Generic versus non-generic formulation of extended-release clarithromycin in patients with community-acquired respiratory tract infections: A prospective, randomized, comparative, investigator-blind, multicentre study

Clinical Drug Investigation

Volumn 29, Issue 4, 2009, Pages 265-274

  Snyman, J R ^a   Schoeman, H S ^b   Grobusch, M P ^c   Henning, M ^d   Rabie, W ^e   Hira, M ^f   Parshotam, K ^b   Mithal, Y ^b   Singh, S ^g   Ramdas, Z ^g  

^a UNIVERSITY OF PRETORIA   (South Africa)

^b University of the Witwatersrand ^*

^c UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^d Vermaak and Partners Pathologists   (South Africa)

^e UNIVERSITY OF THE FREE STATE   (South Africa)

^f Tshepong Health Centre   (South Africa)

^g Ranbaxy (SA) (Pty) Ltd   (South Africa)

Author keywords

[No Author keywords available]

Indexed keywords

CLARITHROMYCIN; GENERIC DRUG; KLACID XL; KLARITHRAN MR; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ABDOMINAL TENDERNESS; ADULT; ARTICLE; CLINICAL TRIAL; COMMUNITY ACQUIRED PNEUMONIA; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PHARYNGITIS; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RHINOSINUSITIS; SINGLE BLIND PROCEDURE; TASTE DISORDER; TONSILLITIS;

EID: 62949127574     PISSN: 11732563     EISSN: None     Source Type: Journal    
DOI: 10.2165/00044011-200929040-00005     Document Type: Article

References (21)

1. Fogarty CM, Kohno S, Buchanan P, et al. Community-acquired respiratory tract infections caused by resistant pneumococci: clinical and bacteriological efficacy of the ketolide telithromycin. J Antimicrob Chemother 2003 Mar 13; 51: 947-55
2. Lieberman D, Shvartzman P, Lieberman D, et al. Etiology of respiratory tract infection in adults in a general practice setting. Eur J Clin Microbiol Infect Dis 1998; 17: 685-9
3. Klugman KP. Implications for antimicrobial prescribing of strategies based on bacterial eradication. Int J Infect Dis 2003; 7: S27-31
4. Dagan R, Klugman KP, Craig WA, et al. Evidence to support the rationale that bacterial eradication in respiratory tract infection is an important aim of antimicrobial therapy. J Antimicrob Chemother 2001; 47: 129-40
5. Feldman C, Brink AJ, Richards GA, et al. Management of community-acquired pneumonia in adults. S Afr Med J 2007; 97 (12): 1296-306
6. Gotfried MH. Clarithromycin (Biaxin) extended-release tablet: a therapeutic review. Expert Rev Anti-infect Ther 2003; 1 (1): 9-20
7. Esposito S, Noviello S, Boccazzi A, et al. Management of upper respiratory tract infections in primary care in Italy: a national survey. Int J Antimicrob Agents 2001; 17: 189-94
8. Brink AJ, Working Group of the Infectious Diseases Society of Southern Africa. Guideline for the management of upper respiratory tract infections. S Afr Med J 2004 Jun; 94 (6): 473-84
9. Anzueto A, Norris S. Clarithromycin in 2003: sustained efficacy and safety in an era of rising antibiotic resistance. Int J Antimicrob Agents 2004; 24: 1-17
10. Drehobl MA, De Salvo MC, Lewis DE, et al. Single-dose azithromycin microspheres vs clarithromycin extended release for the treatment of mild-to-moderate community-acquired pneumonia in adults. Chest 2005; 128: 2230-7
11. Clinical and Laboratory Standards Institute. Performance standards for antimicrobial susceptibility testing. 17th Informational Supplement 2007 January 27; 1: M100-S17
12. AIDS Clinical Trial Group. Table of grading severity of adverse experiences. Rockville (MD): Division of Aids, National Institute of Allergy and Infectious Diseases, 1996
13. Darkes MJM, Perry CM. Clarithromycin extended-release tablet: a review of its use in the management of respiratory tract infections. Am J Respir Med 2003; 2 (2): 175-201
14. Murray JJ, Solomon E, McCluskey D, et al. Phase III, randomized, double-blind study of clarithromycin extended-release formulations in the treatment of adult patients with acute maxillary sinusitis. Clin Ther 2000; 22: 1421-32
15. Pichichero ME. Pathogen shifts and changing cure rates for otitis media and tonsillopharyngitis. Clin Pediatr 2006; 45: 493-502
16. Bloom BS. Daily regimen and compliance with treatment [editorial]. BMJ 2001; 323: 647
17. Rudd P, Lenert L. Pharmacokinetics as an aid to optimizing compliance with medications. Clin Pharmacokinet 1995; 28: 1-6
18. Robinson DH, Narducci WA, Ueda CT. Drug delivery and administration. In: DiPiro JT, Talbert FL, Yee GC, editors. Pharmacotherapy: a pathophysiologic approach. 4th ed. Stamford (CT): Appleton & Lange, 1999: 49-76
19. Denny FW, Wannamaker LW, Brink WR, et al. Prevention of rheumatic fever: treatment of the preceding streptococcal infection. Landmark article May 13, 1950. JAMA 1985; 254: 534-7
20. Shaw E, Anderson JG, Maloney M, et al. Factors associated with noncompliance of patients taking antihypertensive medications. Hosp Pharm 1995; 30: 201-3, 206-7
21. National Antimicrobial Surveillance Forum (NASF): South Africa, 2005