Clarithromycin in 2003: Sustained efficacy and safety in an era of rising antibiotic resistance

International Journal of Antimicrobial Agents

Volumn 24, Issue 1, 2004, Pages 1-17

  Anzueto, Antonio ^a   Norris, Sandra ^b  

^a UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^b WAYNE STATE UNIVERSITY   (United States)

Author keywords

Antibiotic resistance; Clarithromycin; Respiratory tract infection

Indexed keywords

AMOXICILLIN; ANTIBIOTIC AGENT; BETA LACTAM ANTIBIOTIC; CLARITHROMYCIN; CLAVULANIC ACID; ERYTHROMYCIN; GATIFLOXACIN; GREPAFLOXACIN; LEVOFLOXACIN; MACROLIDE; MOXIFLOXACIN; SPARFLOXACIN; TROVAFLOXACIN;

ABDOMINAL PAIN; ANTIBIOTIC RESISTANCE; ANTIMICROBIAL ACTIVITY; BACTERIAL INFECTION; CHRONIC BRONCHITIS; CLINICAL TRIAL; CORRELATION ANALYSIS; DIARRHEA; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG RELEASE; DRUG SAFETY; DRUG TOLERABILITY; GASTROINTESTINAL SYMPTOM; HAEMOPHILUS INFLUENZAE; HAEMOPHILUS PARAINFLUENZAE; HEADACHE; HEALTH SURVEY; HUMAN; INFECTION PREVENTION; INFECTION SENSITIVITY; MORAXELLA CATARRHALIS; OUTPATIENT DEPARTMENT; PHARYNGITIS; PNEUMONIA; PREDICTION; PRIORITY JOURNAL; REVIEW; SIDE EFFECT; SINUSITIS; STATISTICAL ANALYSIS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PYOGENES; TABLET FORMULATION; TREATMENT FAILURE; VOMITING;

ANTI-BACTERIAL AGENTS; CLARITHROMYCIN; DRUG RESISTANCE; HUMANS; RESPIRATORY TRACT INFECTIONS;

EID: 3042600593     PISSN: 09248579     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijantimicag.2004.03.003     Document Type: Review

References (163)

1. EU Economic and Social Committee, Opinion of the Economic and Social Committee on the 'Resistance to antibiotics as a threat to public health'; 1998 (98/C407/02).
2. US Department of Health and Human Services, Draft Public health Action Plan to Combat Antimicrobial Resistance. Federal Register 2000;65(121):38832-33.
3. World Health Organization, WHO Global Strategy for Containment of Antimicrobial Resistance. WHO/CDS/CSR/DRS/2001.2.
4. EMEA, EMEA Discussion Paper on Antimicrobial Resistance, March 1999 (EMEA/9880/99 Rev. 1).
5. EU Council, Council Resolution on antibiotic resistance (a strategy against the microbial threat); 1999 (C195/01).
6. EU Council Recommendation on the Prudent Use of Antimicrobial Agents in Human Medicine; 2002 (77/EC).
7. European Commission. Proposal for a Council Recommendation in the Prudent Use of Antimicrobial Agents in Human Medicine; June 2001 (COM(2001)333 final).
8. Jones R.N., Pfaller M.A. In vitro activity of newer fluoroquinolones for respiratory tract infections and emerging patterns of antimicrobial resistance: data from the SENTRY antimicrobial surveillance program. Clin. Infect. Dis. 31(Suppl. 2):2000;S16-S23
9. Felmingham D, Gruneberg RN, Alexander Project Group. The Alexander Project 1996-1997: latest susceptibility data from this international study of bacterial pathogens from community-acquired lower respiratory tract infections. J Antimicrob Chemother 2000;45:191-203.
10. Schito G.C., Debbia E.A., Marchese A. The evolving threat of antibiotic resistance in Europe: new data from the Alexander Project. J. Antimicrob. Chemother. 46:2000;3-9
11. Hoban D., Felmingham D. The PROTEKT surveillance study: antimicrobial susceptibility of Haemophilus influenzae and Moraxella catarrhalis from community-acquired respiratory tract infections. J. Antimicrob. Chemother. 50(Suppl. S1):2002;49-59
12. Felmingham D., Reinert R.R., Hirakata Y., Rodloff A. Increasing prevalence of antimicrobial resistance among isolates of Streptococcus pneumoniae from the PROTEKT surveillance study, and comparative in vitro activity of the ketolide, telithromycin. J. Antimicrob. Chemother. 50(Suppl. S1):2002;25-37
13. Sahm D.F., Jones M.E., Hickey M.L., Diakun D.R., Mani S.V., Thornsberry C. Resistance surveillance of Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis isolated in Asia and Europe, 1997-1998. J. Antimicrob. Chemother. 45:2000;457-466
14. Thornsberry C., Sahm D.F., Kelly L.J., et al. Regional trends in antimicrobial resistance among clinical isolates of Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis in the United States: results from the TRUST surveillance program, 1999-2000. Clin. Infect. Dis. 34(Suppl. 1):2002;S4-S16
15. Doern G.V., Heilmann K.P., Huynh H.K., et al. Antimicrobial resistance among clinical isolates of Streptococcus pneumoniae in the United States during 1999-2000, including a comparison of resistance rates since 1994-1995. Antimicrob. Agents Chemother. 45:2001;1721-1729
16. Thornsberry C., Jones M.E., Hickey M.L., Mauriz Y., Kahn J., Sahm D.F. Resistance surveillance of Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis isolated in the United States, 1997-1998. J. Antimicrob. Chemother. 44:1999;749-759
17. Breiman R.F., Butler J.C., Tenover F.C., Elliott J.A., Facklam R.R. Emergence of drug-resistant pneumococcal infections in the United States. J. Am. Med. Assoc. 271:1994;1831-1835
18. Doern G.V., Pfaller M.A., Kugler K., Freeman J., Jones R.N. Prevalence of antimicrobial resistance among respiratory isolates of Streptococcus pneumoniae in North America, 1997 results from the SENTRY Antimicrobial Surveillance Program. Clin. Infect. Dis. 27:1998;764-770
19. Goldsmith C.E., Moore J.E., Murphy P.G., Ambler J.E. Increased incidence of ciprofloxacin resistance in penicillin-resistant pneumococci in Northern Ireland. J. Antimicrob. Chemother. 41:1998;420-421
20. Whitney C.G., Farley M.M., Hadler J., et al. Increasing prevalence of multi-drug resistant Streptococcus pneumoniae in the United States. N. Engl. J. Med. 343:2000;1917-1924
21. Corso A., Severina E.P., Petruk V.F., Mauriz Y.R., Tomasz A. Molecular characterization of penicillin-resistant Streptococcus pneumoniae isolates causing respiratory disease in the United States. Microb. Drug Resist. 4:1998;325-337
22. Thornsberry C., Sahm D.F. Resistance in respiratory tract pathogens: an international study 1997-1998. J. Chemother. 12(Suppl. 4):2000;16-20
23. Schmitz F-J, Verhoef J, Fluit AC, The Sentry Participants Group. Prevalence of resistance to MLS antibiotics in 20 European university hospitals participating in the European SENTRY surveillance programme. J Antimicrob Chemother 1999;43:783-92.
24. Washington JA, The Alexander Project Group. A multicenter study of the antimicrobial susceptibility of community-acquired lower respiratory tract pathogens in the United States, 1992-1994. The Alexander project. Diagn Microbiol Infect Dis 1996;25:183-90.
25. Gruneberg RN, Felmingham D, The Alexander Project Group. Results of the Alexander Project: a continuing, multicenter study of the antimicrobial susceptibility of community-acquired lower respiratory tract bacterial pathogens. Diagn Microbiol Infect Dis 1996;25:169-81.
26. Jacobs MR, Felmingham D, Appelbaum PC, Grüneberg RN, The Alexander Project Group. The Alexander Project 1998-2000: susceptibility of pathogens isolated from community-acquired respiratory tract infection to commonly used antimicrobial agents. J Antimicrob Chemother 2003;52:229-46.
27. Hoban D., Waites K., Felmingham D. Antimicrobial susceptibility of community-acquired respiratory tract pathogens in North America in 1999-2000: findings of the PROTEKT surveillance study. Diagn. Microbiol. Infect. Dis. 45:2003;251-259
28. Farrell D.J., Morrissey I., Bakker S., Felmingham D. Molecular characterization of macrolide resistance mechanisms among Streptococcus pneumoniae and Streptococcus pyogenes isolated from the PROTEKT 1999-2000 study. J. Antimicrob. Chemother. 50(Suppl. 1):2002;39
29. Levine O.S., Farley M., Harrison L.H., Lefkowitz L., McGeer A., Schwartz B. Risk factors for invasive pneumococcal disease in children: a population-based case-control study in North America. Pediatrics. 103:1999;E28
30. Bishai W, Olson CA, Shortridge VD, Doern GV. Susceptibility of Streptococcus pneumoniae to macrolides in immunocompetent adults with community-acquired pneumonia. In: Proceedings of the Program and Abstracts of the 38th Annual Meeting of the Infectious Diseases Society of America, New Orleans, 7-10 September 2000 [abstract 95].
31. Reinert R.R., Simic S., Al-Lahham A., Reiner S., Lemperle M., Lutticken R. Antimicrobial resistance of Streptococcus pneumoniae recovered from outpatients with respiratory tract infections in Germany from 1998 to 1999: results of a national surveillance study. J. Clin. Microbiol. 39:2001;1187-1189
32. Tubau F, Linares J, Roson B, Pallares R, Gudiol F, Martin R. In vitro activities of 11 antimicrobials against 246 Streptococcus pneumoniae strains isolated from adult patients with community-acquired pneumonia. In: Proceedings of the Program and Abstracts of the 11th European Congress of Clinical Microbiology and Infectious Disease, Istanbul, Turkey, 1-4 April 2001 [abstract P896].
33. Baquero F. Evolving resistance patterns of Streptococcus pneumoniae: a link with long-acting macrolide consumption? J. Chemother. 11(Suppl. 1):1999;35-43
34. European Antimicrobial Resistance Surveillance System (EARSS) Annual Report 2001. http://www.earss.rivm.nl.
35. Jacobs M.R., Bajaksouzian S., Zilles A., Lin G., Pankuch G.A., Appelbaum P.C. Susceptibilities of Streptococcus pneumoniae and Haemophilus influenzae to 10 oral antimicrobial agents based on pharmacodynamic parameters: 1997 US surveillance study. Antimicrob. Agents Chemother. 43:1999;1901-1908
36. Gotfried M.H. Comparison of bacteriologic eradication of Streptococcus pneumoniae by clarithromycin and reports of increased antimicrobial resistance. Clin. Ther. 22:2000;2-14
37. Benson C.A., Segreti J., Beaudette F.E., et al. In vitro activity of A-56268 (TE-031), a new macrolide, compared with that of erythromycin and clindamycin against selected gram-positive and gram-negative organisms. Antimicrob. Agents Chemother. 31:1987;328-330
38. Chin N.X., Neu N.M., Labthavikul P., Saha G., Neu H.C. Activity of A-56268 compared with that of erythromycin and other oral agents against aerobic and anaerobic bacteria. Antimicrob. Agents Chemother. 31:1987;463-466
39. Eliopoulos G.M., Reiszner E., Ferraro M.J., Moellering R.C. Comparative in-vitro activity of A-56268 (TE-031), a new macrolide antibiotic. J. Antimicrob. Chemother. 20:1987;671-675
40. Fass R.J. Erythromycin, clarithromycin, and azithromycin: use of frequency distribution curves, scattergrams, and regression analyses to compare in vitro activities and describe cross-resistance. Antimicrob. Agents Chemother. 37:1993;2080-2086
41. Loza E., Martinez Beltran J., Baquero F., Leon A, Canton R., Garijo B. Comparative in vitro activity of clarithromycin. Spanish Collaborative Group. Eur. J. Clin. Microbiol. Infect. Dis. 11:1992;856-866
42. Sefton A.M., Maskell J.P., Yong F.J., Chi S.J., Williams J.D. Comparative in vitro activity of A-56268. Eur. J. Clin. Microbiol. Infect. Dis. 7:1988;798-802
43. Shortridge V.D., Flamm R.K., Ramer N., Beyer J., Tanaka S.K. Novel mechanism of macrolide resistance in Streptococcus pneumoniae. Diagn. Microbiol. Infect. Dis. 26:1996;73-78
44. Sutcliffe J., Tait-Kamradt A., Wondrack L. Streptococcus pneumoniae and Streptococcus pyogenes resistant to macrolides but sensitive to clindamycin: a common resistance pattern mediated by an efflux system. Antimicrob. Agents Chemother. 40:1996;1817-1824
45. Doern G.V., Brueggemann A.B., Huynh H., Wingert E., Rhomberg P. Antimicrobial resistance with Streptococcus pneumoniae in the United States, 1997-1998. Emerg. Infect. Dis. 5:1999;757-776
46. Shortridge V.D., Doern G.V., Brueggemann A.B., Beyer J.M., Flamm R.K. Prevalence of macrolide resistance mechanisms in Streptococcus pneumoniae isolates from a multicenter antibiotic resistance surveillance study conducted in the United States in 1994-1995. Clin. Infect. Dis. 29:1999;1186-1188
47. Hoban D.J., Wierzbowski A.K., Nichol K., Zhanel G.G. Macrolide-resistant Streptococcus pneumoniae in Canada during 1998-1999: prevalence of mef(A) and erm(B) and susceptibilities to ketolides. Antimicrob. Agents Chemother. 45:2001;2147-2150
48. Barry A.L. In vitro potency of nine orally administered antimicrobial agents against three respiratory tract pathogens. Eur. J. Clin. Microbiol. Infect. Dis. 11:1992;867-869
49. Canton R., Loza E., Morosini I., Baquero F. Antimicrobial resistance amongst isolates of Streptococcus pyogenes and Staphylococcus aureus in the PROTEKT antimicrobial surveillance programme during 1999-2000. J. Antimicrob. Chemother. 50(Suppl. S1):2002;9-24
50. Roberts M.C., Sutcliffe J., Courvalin P., Bogo Jensen L.B., Rood J., Seppala H. Nomenclature for macrolides and macrolide-lincosamide-streptogramin B resistance determinants. Antimicrob. Agents Chemother. 43:1999;2823-2830
51. Barry A.L., Jones R.N., Thornsberry C. In vitro activities of azithromycin (CP 62, 993), clarithromycin (A-56268; TE-031), erythromycin, roxithromycin, and clindamycin. Antimicrob. Agents Chemother. 32:1988;752-754
52. Fernandes P.B., Bailer R., Swanson R., et al. In vitro and in vivo evaluation of A-56268 (TE-031), a new macrolide. Antimicrob. Agents Chemother. 30:1986;865-873
53. Floyd-Reising S., Hindler J.A., Young L.S. In vitro activity of A-56268 (TE-031), a new macrolide antibiotic, compared with that of erythromycin and other antimicrobial agents. Antimicrob. Agents Chemother. 31:1987;640-642
54. Hardy D.J., Hensey D.M., Beyer J.M., Vojtko C., McDonald E.J., Fernandes P.B. Comparative in vitro activities of new 14-, 15-, and 16-membered macrolides. Antimicrob. Agents Chemother. 32:1988;1710-1719
55. Bergeron M.G., Bernier M., L'Ecuyer J. In vitro activity of clarithromycin and its 14-hydroxy-metabolite against 203 strains of Haemophilus influenzae. Infection. 20:1992;164-167
56. Barry A.L., Fuchs P.C., Pfaller M.A. Susceptibility of Haemophilus influenzae to clarithromycin alone or in combination with its 14-hydroxy metabolite. Eur. J. Clin. Microbiol. Infect. Dis. 10:1991;1080-1081
57. Barry A.L., Thornsberry C., Jones R.N. In vitro activity of a new macrolide, A-56268, compared with that of roxithromycin, erythromycin, and clindamycin. Antimicrob. Agents Chemother. 31:1987;343-345
58. Pankuch G.A., Kelly L.M., Lin G., et al. Activities of a new oral streptogramin XRP 2868, compared to those of other agents against Streptococcus pneumoniae and Haemophilus species. Antimicrob. Agents Chemother. 47:2003;3270-3274
59. Bozdogan B., Clark C., Bryskier A., Jacobs M.R., Appelbaum P.C. Activities of HMR 3787 and RU 64399 compared with those of four other agents against Haemophilus influenzae and Haemophilus parainfluenzae. Antimicrob. Agents Chemother. 47:2003;405-407
60. Johnson D.M., Erwin M.E., Barrett M.S., Gooding B.B., Jones R.N. Antimicrobial activity of ten macrolide, lincosamine and streptogramin drugs tested against Legionella species. Eur. J. Clin. Microbiol. Infect. Dis. 11:1992;751-755
61. Jones R.N., Barry A.L. The antimicrobial activity of A-56268 (TE-031) and roxithromycin (RU965) against Legionella using broth microdilution method. J. Antimicrob. Chemother. 19:1987;841-842
62. Fenelon L.E., Mumtaz G., Ridgway G.L. The in-vitro antibiotic susceptibility of Chlamydia pneumoniae. J. Antimicrob. Chemother. 26:1990;763-767
63. Hammerschlag M.R., Qumei K.K., Roblin P.M. In vitro activities of azithromycin, clarithromycin, L-ofloxacin, and other antibiotics against Chlamydia pneumoniae. Antimicrob. Agents Chemother. 36:1992;1573-1574
64. Qumei M, Roblin P, Hammerschlag M. In vitro activity of clarithromycin, azithromycin, and erythromycin against Chlamydia pneumoniae. In: Proceedings of the Program and Abstracts of the 1st International Conference on Macrolides, Azalides, and Streptogramins, Santa Fe, NM, 22-25 January 1992 [abstract 147].
65. Renaudin H., Bebear C. Comparative in vitro activity of azithromycin, clarithromycin, erythromycin and lomefloxacin against Mycoplasma pneumoniae, Mycoplasma hominis and Ureaplasma urealyticum. Eur. J. Clin. Microbiol. Infect. Dis. 9:1990;838-841
66. Segreti J, Kapell K. In vitro activity of clarithromycin and 14-OH clarithromycin against TWAR compared to doxycycline. In: Proceedings of the Program and Abstracts of the 1st International Conference on Macrolides, Azalides, and Streptogramins, Santa Fe, NM, 22-25 January 1992 [abstract 148].
67. Waites K.B., Cassell G.H., Canupp K.C., Fernandes P.B. In vitro susceptibilities of mycoplasmas and ureaplasmas to new macrolides and aryl-fluoroquinolones. Antimicrob. Agents Chemother. 32:1988;1500-1502
68. Critchley I.A., Jones M.E., Heinze P.D., et al. In vitro activity of levofloxacin against contemporary clinical isolates of Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydia pneumoniae from North America and Europe. Clin. Microbiol. Infect. 8:2002;214-221
69. Guay D.R.P., Gustavson L.E., Devcich K.J., Zhang J., Cao G., Olson C.A. Pharmacokinetics and tolerability of extended-release clarithromycin. Clin. Ther. 23:2001;566-577
70. Data on file, Abbott Laboratories.
71. Chu S., Deaton R., Cavanaugh J. Absolute bioavailability of clarithromycin after oral administration in humans. Antimicrob. Agents Chemother. 36:1992;1147-1150
72. Bearden D.T., Rodvold K.A. Practical pharmacology - penetration of macrolides into pulmonary sites of infection. Infect. Med. 16:1999;480A-484A
73. Rodvold K.A., Gotfried M.H., Danziger L.H., Sorvi R.J. Intrapulmonary steady-state concentrations of clarithromycin and azithromycin in healthy adult volunteers. Antimicrob. Agents Chemother. 41:1997;1399-1402
74. Fish D.N., Gotfried M.H., Danziger L.H., Rodvold K.A. Penetration of clarithromycin into lung tissues from patients undergoing lung resection. Antimicrob. Agents Chemother. 38:1994;876-878
75. Hoover W.W., Barrett M.S., Jones R.N. Clarithromycin in vitro activity enhanced by its major metabolite, 14-hydroxyclarithromycin. Diagn. Microbiol. Infect. Dis. 15:1992;259-266
76. Craig WA. Postantibiotic effects and the dosing of macrolides, azalides, and streptogramins. In: Zinner SH, Young LS, Acar JF, Neu HC, editors. Expanding indications for the new macrolides, azalides, and streptogramins. New York: Marcel Dekker; 1997. p. 27-38.
77. Tessier P.R., Kim M.-K., Zhou W., et al. Pharmacodynamic assessment of clarithromycin in a murine model of pneumococcal pneumonia. Antimicrob. Agents Chemother. 46:2002;1425-1434
78. Craig WA, Kiem S, Andes DR. Free drug 24-h AUC/MIC is the PK/PD target that correlates with in vivo efficacy of macrolides, azalides, ketolides, and clindamycin. In: Proceedings of the Program and Abstracts of the 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, CA, 27-30 September 2002 [abstract A-1264].
79. Periti P., Mazzei T. Clarithromycin: pharmacokinetic and pharmacodynamic interrelationships and dosage regimen. J. Chemother. 11:1999;11-27
80. Noreddin A.M., Roberts D., Nichol K., Wierzbowski A., Hoban D.J., Zhanel G.G. Pharmacodynamic modeling of clarithromycin against macrolide-resistant [PCR-positive mef(A) or erm(B)] Streptococcus pneumoniae simulating clinically achievable serum and epithelial lining fluid free-drug concentrations. Antimicrob. Agents Chemother. 46:2002;4029-4034
81. Stein G.E., Schooley S. Comparative serum bactericidal activity of clarithromycin and azithromycin against macrolide-sensitive and resistant strains of Streptococcus pneumoniae. Diagn. Microbiol. Infect. Dis. 39:2001;181-185
82. National Committee for Clinical Laboratory Standards: Performance Standards for Antimicrobial Susceptibility Testing. Twelfth Informational Supplement; January 2002;22 (1).
83. Amsden G.W. Pneumococcal macrolide resistance: myth or reality? J. Antimicrob. Chemother. 44:1999;1-6
84. Hoffman H.L., Klepser M.E., Ernst E.J., et al. Influence of macrolide susceptibility on efficacies of clarithromycin and azithromycin against Streptococcus pneumoniae in a murine lung infection model. Antimicrob. Agents Chemother. 47:2003;739-746
85. Maglio D, Capitano B, Banevicius MA, Geng Q, Nightingale CH, Nicolau DP. Differential efficacy of clarithromycin in lung versus thigh infection models. Chemotherapy, 2004;50:63-6.
86. Anthonisen N.R., Manfreda J., Warren C.P., Hershfield E.S., Harding G.K., Nelson N.A. Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann. Intern. Med. 106:1987;196-204
87. Fogarty C., Grossman C., Williams J., Haverstock D., Church D. Efficacy and safety of moxifloxacin vs. clarithromycin for community-acquired pneumonia. Inf. Med. 16:1999;748-763
88. Ramirez J, Nguyen TH, Tellier G, et al. Once daily 400 mg oral gatifloxacin (GAT) vs. twice daily 500 mg oral clarithromycin (CLA) in the treatment of community-acquired pneumonia (CAP). In: Proceedings of the Program and Abstracts of the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, CA, 26-29 September 1999 [abstract 2242].
89. Ramirez J., et al. Sparfloxacin vs. clarithromycin in the treatment of community-acquired pneumonia. Clin. Ther. 21:1999;103-116
90. Moola S., Hagverg L., Churchyard G.A., Dylewski J.S., Sedani S., Staley H. A multicenter study of grepafloxacin and clarithromycin in the treatment of patients with community-acquired pneumonia. Chest. 116:1999;974-983
91. Drnec J, Vance A, Avila M, Morris D, Busman T, Notario G. Safety and efficacy comparison of clarithromycin immediate release with trovafloxacin in community-acquired pneumonia. In: Proceedings of the Program and Abstracts of the International Conference on Macrolides, Azalides, Streptogramins, Ketolides, and Oxazolidinones, Seville, Spain, 26-28 January 2000 [abstract 04.25].
92. Hoeffken G, Meyer HP, Winter J, Verhoef L, for the CAP1 Study Group. The efficacy and safety of two oral moxifloxacin regimens (200 mg or 400 mg once-daily × 10 days) compared to oral clarithromycin (500 mg twice-daily × 10 days) in the treatment of community-acquired pneumonia. Respir Med 2001;95:553-64.
93. Gotfried M.H., Dattani D., Riffer E., et al. A controlled, double-blind, multi-center study comparing clarithromycin extended-release tablets and levofloxacin tablets in the treatment of community-acquired pneumonia. Clin. Ther. 24:2002;736-751
94. Sokol W.N., Sullivan J.G., Acampora M.D., et al. A prospective, double-blind, multi-center study comparing clarithromycin extended-release with trovafloxacin in patients with community-acquired pneumonia. Clin. Ther. 24:2002;605-615
95. Bonvehi P., Weber K., Busman T., Shortridge D., Notario G. Comparison of clarithromycin and amoxicillin/clavulanic acid for community-acquired pneumonia in a era of drug-resistant Streptococcus pneumoniae. Clin. Drug Invest. 23:2003;491-501
96. Chodosh S., Schreurs A., Siami G., et al. Efficacy of oral ciprofloxacin vs. clarithromycin for treatment of acute bacterial exacerbations of chronic bronchitis. Clin. Infect. Dis. 27:1998;730-738
97. Ziering W., McElvaine P. Randomized comparison of once-daily ceftibuten and twice-daily clarithromycin in the treatment of acute exacerbation of chronic bronchitis. Infection. 26:1998;68-75
98. DeAbate C.A., Myers D., Henry D., et al. Efficacy and tolerability of once-daily grepafloxacin compared with clarithromycin in the treatment of acute bacterial exacerbations of chronic bronchitis. Clin. Drug Invest. 17:1999;21-31
99. Langan C.E., Zuck P., Vogel F., et al. Randomized, double-blind study of short-course (5 day) grepafloxacin versus 10 day clarithromycin in patients with acute bacterial exacerbations of chronic bronchitis. J. Antimicrob. Chemother. 44:1999;515-523
100. Wilson R., Kubin R., Ballin I., et al. Five day moxifloxacin therapy compared with 7 day clarithromycin therapy for the treatment of acute exacerbations of chronic bronchitis. J. Antimicrob. Chemother. 44:1999;501-513
101. Lipsky B.A., Unowsky J., Zhang H., Townsend L., Talbot G.H. Treating acute bacterial exacerbations of chronic bronchitis in patients unresponsive to previous therapy: sparfloxacin versus clarithromycin. Clin. Ther. 21:1999;954-965
102. Chodosh S, DeAbate CA, Haverstock D, Aneiro L, Church, and the Bronchitis Study Group. Short-course moxifloxacin therapy for treatment of acute bacterial exacerbations of chronic bronchitis. Resp Med 2000;94:18-27.
103. Adler J.L., Jannetti W., Schneider D., Zhang J., Palmer R., Notario G. Phase III, randomized, double-blind study of clarithromycin extended-release and immediate-release formulations in the treatment of patients with acute exacerbation of chronic bronchitis. Clin. Ther. 22:2000;1410-1420
104. Adam D., Glaser-Caldow E., Wachter J., et al. Comparative efficacy of clarithromycin modified-release and clarithromycin immediate-release formulations in the treatment of lower respiratory tract infections. Clin. Ther. 23:2001;585-595
105. Allin D., James I., Zachariah J., et al. Comparison of once- and twice-daily clarithromycin in the treatment of adults with severe acute lower respiratory tract infections. Clin. Ther. 23:2001;1958-1968
106. Anzueto A., Fisher C.L., Busman T., Olson C.A. Comparison of the efficacy of extended-release clarithromycin tablets and amoxicillin/clavulanate tablets in the treatment of acute exacerbation of chronic bronchitis. Clin. Ther. 23:2001;72-86
107. Gotfried M.H., DeAbate C.A., Fogarty C., Mathew C.P., Sokol W.N. Comparison of 5-day, short-course gatifloxacin therapy with 7-day gatifloxacin therapy and 10-day clarithromycin therapy for acute exacerbation of chronic bronchitis. Clin. Ther. 23:2001;97-107
108. Martinot J.B., Carr W.D., Cullen S., et al. A comparative study of clarithromycin modified release and amoxicillin/clavulanic acid in the treatment of acute exacerbation of chronic bronchitis. Adv. Ther. 18:2001;1-11
109. McCarty J.M., Pierce P.F. Five days of cefprozil versus 10 days of clarithromycin in the treatment of an acute exacerbation of chronic bronchitis. Ann. Allergy Asthma Immunol. 87:2001;327-334
110. Wilson R, Schentag JJ, Ball P, Mandell L, for the 068 Study Group. A comparison of gemifloxacin and clarithromycin in acute exacerbations of chronic bronchitis and long-term clinical outcomes. Clin Ther 2002;24:639-52.
111. Nalepa P., Dobryniewska M., Busman T., Notario G. Short-course therapy of acute bacterial exacerbation of chronic bronchitis: a double blind, randomized, multicenter comparison of extended release vs. immediate release clarithromycin. Curr. Med. Res. Opin. 19:2003;411-420
112. Dubois J., Saint-Pierre C., Temblay C. Efficacy of clarithromycin vs. amoxicillin/clavulanate in the treatment of acute maxillary sinusitis. Ear Nose Throat J. 72:1993;804-810
113. Stefansson P., Jacovides A., Jablonicky P., Sedani S., Staley H. Cefuroxime axetil versus clarithromycin in the treatment of acute maxillary sinusitis. Rhinology. 36:1998;173-178
114. Adelglass J., Jones T.M., Ruoff G., et al. A multicenter, investigator-blinded, randomized comparison of oral levofloxacin and oral clarithromycin in the treatment of acute bacterial sinusitis. Phamacotherapy. 18:1998;1255-1263
115. Lasko B., Lau C.Y., Saint-Pierre C., et al. Efficacy and safety of oral levofloxacin compared with clarithromycin in the treatment of acute sinusitis in adults: a multicentre, double-blind, randomized study. J. Int. Med. Res. 26:1998;281-291
116. Fogarty C., et al. Gatifloxacin vs. clarithromycin in the management of acute sinusitis. J. Resp. Dis. 20:1999;S17-S22
117. Henry D.C., Moller D.J., Adelglass J., et al. Comparison of sparfloxacin and clarithromycin in the treatment of acute bacterial maxillary sinusitis. Clin. Ther. 21:1999;340-352
118. Clifford K., Huck W., Shan M., Tosiello R., Echols R.M., Heyd A. Double-blind comparative trial of ciprofloxacin versus clarithromycin in the treatment of acute bacterial sinusitis. Ann. Otol. Rhinol. 108:1999;360-367
119. Murray J.J., et al. Phase III, randomized, double-blind study of clarithromycin extended-release and immediate-release formulations in the treatment of adult patients with acute maxillary sinusitis. Clin. Ther. 22:2000;1421-1432
120. Levenstein J.H. Clarithromycin versus penicillin in the treatment of streptococcal pharyngitis. J. Antimicrob. Chemother. 27(Suppl. A):1991;67-74
121. Bachand R.T. A comparative study of clarithromycin and penicillin VK in the treatment of outpatients with streptococcal pharyngitis. J. Antimicrob. Chemother. 27(Suppl. A):1991;75-82
122. Stein G.E., Christensen S., Mummaw N. Comparative study of clarithromycin and penicillin V in the treatment of streptococcal pharyngitis. Eur. J. Clin. Microbiol. Infect. Dis. 10:1991;949-953
123. Schrock C.G. Clarithromycin vs. penicillin in the treatment of streptococcal pharyngitis. J. Fam. Pract. 35:1992;622-626
124. Still J.G., Hubbard W.C., Poole J.M., Sheaffer C.I., Chartrand S., Jacobs R. Comparison of clarithromycin and penicillin VK suspensions in the treatment of children with streptococcal pharyngitis and review of currently available alternative antibiotic therapies. Pediatr. Infect. Dis. J. 12(Suppl. 3):1993;S134-S141
125. Kearsley N.L., Campbell A., Sanderson A.A., Weir R.D., Kamdar M.K., Coles S.J. Comparison of clarithromycin suspension and amoxycillin syrup for the treatment of children pharyngitis and/or tonsillitis. Br. J. Clin. Pract. 51:1997;133-137
126. Venuta A., Laudizi L., Beverelli A., Bettelli F., Milioli S., Garetti E. Azithromycin compared with clarithromycin for the treatment of streptococcal pharyngitis in children. J. Int. Med. Res. 26:1998;152-158
127. McCarty J., Hedrick J.A., Gooch W.M. Clarithromycin suspension vs. penicillin V suspension in children with streptococcal pharyngitis. Adv. Ther. 17:2000;14-26
128. Kaplan E.L., Gooch W.M., Notario G.F. III, Craft J.C. Macrolide therapy of group A streptococcal pharyngitis: ten days of macrolide therapy (clarithromycin) is more effective in streptococcal eradication than five days (azithromycin). Clin. Infect. Dis. 32:2001;1798-1802
129. Quinn J., Ruoff G.E., Ziter P.S. Efficacy and tolerability of 5-day, once-daily telithromycin compared with 10-day, twice-daily clarithromycin for the treatment of group A beta-hemolytic streptococcal tonsillitis/pharyngitis: a multicenter, randomized, double-blind, parallel-group study. Clin. Ther. 25:2003;422-443
130. Takker U., Dzyublyk O., Busman T., Notario G. Comparison of five days of extended-release clarithromycin versus ten days of penicillin v for the treatment of streptococcal pharyngitis/tonsillitis: results of a multicenter, double-blind, randomized study. Curr. Med. Res. Opin. 19:2003;421-429
131. Ewig S., Ruiz M., Torres A., et al. Pneumonia acquired in the community through drug-resistant S. pneumoniae. Am. J. Respir. Crit. Care Med. 159:1999;1835-1842
132. Kelley M., Weber D.J., Gilligan P., Cohen M.S. Breakthrough pneumococcal bacteremia in patients being treated with azithromycin and clarithromycin. Clin. Infect. Dis. 31:2000;1008-1011
133. Lonks J., Garau J., Gomez L., et al. Failure of macrolide antibiotic in patients with bacteremia due to erythromycin-resistant Streptococcus pneumoniae. Clin. Infect. Dis. 35:2002;556-564
134. Pullman J, Boucner J, Patel M, Lavin B. Clinical and bacteriologic efficacy of telithromycin vs. clarithromycin in patients with community-acquired pneumonia due to Streptococcus pneumoniae, including erythromycin-resistant strains. In: Proceedings of the Program and Abstracts of the 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, CA, 27-30 September 2002 [abstract L-372].
135. Van Kerkhoven D., Peetermans W.E., Verbist L., Verhaegen J. Breakthrough pneumococcal bacteremia in patients treated with clarithromycin or oral β-lactams. J. Antimicrob. Chemother. 51:2003;691-696
136. Rowe BH, Campbell S, Hohrmann JA, Spooner C, Camargo Jr CA. S. pneumoniae and resistance in low-risk patients with pneumonia. In: Proceedings of the Program and Abstracts of 99th Annual Meeting of the American Thoracic Society, Seattle, WA, 16-21 May 2003 [abstract A562].
137. Anderson R., Theron A.J., Feldman C. Membrane-stabilizing, anti-inflammatory interactions of macrolides with human neutrophils. Inflammation. 20:1996;693-705
138. Rubin BK, Tamaoki J. Macrolide antibiotics as biological response modifiers. Curr Opin Invest Drugs 2000;1(2).
139. Culic O., Erakovic V., Parnham M.J. Anti-inflammatory effects of macrolide antibiotics. Eur. J. Pharmacol. 429:2001;209-229
140. Jaffe A., Bush A. Anti-inflammatory effects of macrolides in lung disease. Pediatr. Pulmonol. 31:2001;464-473
141. Zalewska-Kaszubska J., Gorska D. Anti-inflammatory capabilities of macrolides. Pharmacol. Res. 44:2001;451-454
142. Hashiba M., Baba S. Efficacy of long-term administration of clarithromycin in the treatment of intractable chronic sinusitis. Acta Otolaryngol. 525(Suppl.):1996;73-78
143. Rubin B.K., Druce H., Ramirez O.E., et al. Effect of clarithromycin on nasal mucus properties in healthy subjects and in patients with purulent rhinitis. Am. J. Respir. Crit. Care Med. 155:1997;2018-2023
144. Yamada T., Fujieda S., Mori S., et al. Macrolide treatment decreased the size of nasal polyps and IL-8 levels in nasal lavage. Am. J. Rhinol. 14:2000;143-148
145. MacLeod C.M., Hamid Q.A., Cameron L., et al. Anti-inflammatory activity of clarithromycin in adults with chronically inflamed sinus mucosa. Adv. Ther. 18:2001;75-82
146. Cervin A., Kalm O., Sandkull P., et al. One-year low-dose erythromycin treatment of persistent chronic sinusitis after sinus surgery: clinical outcome and effects on mucociliary parameters and nasal nitric oxide. Otolaryngol. Head Neck Surg. 126:2002;481-489
147. Nixon LS, Boorman J, Papagiannis AJ, et al. Circulation and airways inflammatory markers in chronic obstructive pulmonary disease (COPD) during an exacerbation (poster K35, ATS 1998). http://www.abstracts-on-line.com/abstracts/ ATSALL. Accessed 3 January 2003.
148. Suzuki T., Yanai M., Yamaya M., et al. Erythromycin and common cold in COPD. Chest. 120:2001;730-733
149. Nagai H., Shishido H., Yoneda R., et al. Long-term low-dose administration of erythromycin to patients with diffuse panbronchiolitis. Respiration. 58:1991;145-149
150. Garey K.W., Alwani A., Danziger L.H., Rubinstein I. Tissue reparative effects of macrolide antibiotics in chronic inflammatory sinopulmonary diseases. Chest. 123:2003;261-265
151. Kadota J., Mukae H., Ishii H., et al. Long-term efficacy and safety of clarithromycin treatment in patients with diffuse panbronchiolitis. Respir. Med. 97:2003;844-850
152. Gotfried M.H., Jung R., Messick C. Placebo controlled trial evaluating the efficacy of clarithromycin in subjects with corticosteroid-dependent asthma [abstract]. J. Antimicrob. Chemother. 44(Suppl. A):1999;100
153. Amayasu H., Yoshida S., Ebana S., et al. Clarithromycin suppresses bronchial hyperresponsiveness associated with eosinophilic inflammation in patients with asthma. Ann. Allergy Asthma Immunol. 84:2000;594-598
154. Garey K.W., Rubinstein I., Gotfried M.H., et al. Long-term clarithromycin decreases prednisone requirements in elderly patients with prednisone-dependent asthma. Chest. 118:2000;1826-1827
155. Nguyen T., Louie S.G., Beringer P.M., Gill M.A. Potential role of macrolide antibiotics in the management of cystic fibrosis lung disease. Curr. Opin. Pulm. Med. 8:2002;521-528
156. Wolter J., Seeney S., Bell S., Bowler S., Masel P., McCormack J. Effect of long term treatment with azithromycin on disease parameters in cystic fibrosis: a randomized trial. Thorax. 57:2002;212-216
157. Saiman L., Marshall B.C., Mayer-Hamblett N., et al. Azithromycin in patients with cystic fibrosis chronically infected with Pseudomonas aeruginosa. J. Am. Med. Assoc. 290:2003;1749-1756
158. Barradell L.B., Plosker G.L., McTavish D. Clarithromycin: a review of its pharmacological properties and therapeutic use in Mycobacterium avium-intracellulare complex infection in patients with acquired immune deficiency syndrome. Drugs. 46:1993;289-312
159. Langtry H.D., Brogden R.N. Clarithromycin: a review of its efficacy in the treatment of respiratory tract infections in immunocompetent patients. Drugs. 53:1997;973-1004
160. Peters D.H., Clissold S.P. Clarithromycin: a review of antimicrobial activity, pharmacokinetic properties, and therapeutic potential. Drugs. 44:1992;117-164
161. Abbott Laboratories. Biaxin® Prescribing Information. North Chicago, IL, USA; 2002.
162. Craft J.C., Siepman N. Overview of the safety profile of clarithromycin suspension in pediatric patients. Pediatr. Infect. Dis. J. 12(Suppl. 3):1993;S142-147
163. Devcich K, Busman T, Olson C, Notario G. Adverse event severity comparisons with extended-release clarithromycin and immediate-release clarithromycin. In: Proceedings of the Program and Abstracts of the 40th Annual Meeting of the Infectious Diseases Society of America, Chicago, IL, 24-27 October 2002 [abstract 212].