Results of a Randomized Trial Comparing Sequential Intravenous/ Oral Treatment with Ciprofloxacin Plus Metronidazole to Imipenem/ Cilastatin for Intra-Abdominal Infections

Annals of Surgery

Volumn 223, Issue 3, 1996, Pages 303-315

  Solomkin, Joseph S ^a   Reinhart, Harald H ^b   Dellinger, E Patchen ^c   Bohnen, John M ^d   Rotstein, Ori D ^e   Vogel, Stephen B ^f   Hank Simms, H ^g   Hill, Carol S ^a   Stephen Bjornson, H ^a   Haverstock, Daniel C ^b   Coulter, Holly O ^b   Echols, Roger M ^b  

^a UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^b BAYER CORPORATION   (United States)

^c UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^d ST MICHAEL'S HOSPITAL   (Canada)

^e UNIVERSITY HEALTH NETWORK   (Canada)

^f UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

^g BROWN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CILASTATIN; CIPROFLOXACIN; IMIPENEM; METRONIDAZOLE;

ABDOMINAL INFECTION; ADULT; ALPHA HEMOLYTIC STREPTOCOCCUS; ANTIMICROBIAL ACTIVITY; ARTICLE; BACTEROIDES FRAGILIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG MIXTURE; DRUG SENSITIVITY; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MICROBIOLOGICAL EXAMINATION; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; PATIENT COMPLIANCE; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ABDOMEN; ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; ANTI-INFECTIVE AGENTS; CILASTATIN; CIPROFLOXACIN; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; HUMANS; IMIPENEM; INFECTION; INFUSIONS, INTRAVENOUS; METRONIDAZOLE; MIDDLE AGED; TREATMENT OUTCOME;

EID: 0029867744     PISSN: 00034932     EISSN: None     Source Type: Journal    
DOI: 10.1097/00000658-199603000-00012     Document Type: Article

References (43)

1. Lennard ES, Dellinger EP, Wertz MJ, Minshew BH. Implications of leukocytosis and fever at conclusion of antibiotic therapy for intra-abdominal sepsis. Ann Surg 1982; 195:19-24.
2. Bohnen JMA, Solomkin JS, Dellinger EP, et al. Guidelines for clinical care: anti-infective agents for intra-abdominal infection. Arch Surg 1992; 127:83-89.
3. Stratton C. Fluoroquinolone antibiotics: properties of the class and individual agents [review]. Clin Ther 1992; 14:348-375; discussion 347.
4. Bauernfeind A. Comparative in-vitro activities of the new quinolone, Bay y 3118, and ciprofloxacin, sparfloxacin, tosufloxacin, CI-960 and CI-990. Antimicrob Agents Chemother 1993; 31:505-522.
5. Thadepalli H, Bansal MB, Rao B, et al. Ciprofloxacin: in vitro, experimental, and clinical evaluation. Rev Infect Dis 1988; 10: 505-515.
6. Paradis D, Vallee F, Allard S, et al. Comparative study of pharmacokinetics and serum bactericidal activities of cefpirome, ceftazidime, ceftriaxome, imipenem, and ciprofloxacin. Antimicrob Agents Chemother 1992; 36:2085-2092.
7. Davis RL, Koup JR, Williams-Warren J, et al. Pharmacokinetics of three oral formulations of ciprofloxacin. Antimicrob Agents Chemother 1985; 28:74-77.
8. Whiting JL, Cheng N, Chow AW. Interactions of ciprofloxacin with clindamycin, metronidazole, cefoxitin, cefotaxime, and mezlocillin against gram-positive and gram-negative anaerobic bacteria. Antimicrob Agents Chemother 1987; 31:1379-1382.
9. Brook I. In vivo efficacies of quinolones and clindamycin for treatment of infections with Bacteroides fragilis and/or Escherichia coli in mice: correlation with in vitro susceptibilities. Antimicrob Agents Chemother 1993; 37:997-1000.
10. Fink MP, Snydman DR, Niederman MS, et al. Treatment of severe pneumonia in hospitalized patients: results of a multicenter, randomized, double-blind trial comparing intravenous ciprofloxacin with imipenem-cilastatin. Antimicrob Agents Chemother 1994; 38:547-557.
11. Lettieri JT, Rogge MC, Kaiser L, et al. Pharmacokinetics profiles of ciprofloxacin after single intravenous and oral doses. Antimicrob Agents Chemother 1992; 36:993-996.
12. Peacock JE Jr, Pegram PS, Weber SF, Leone PA. Prospective, randomized comparison of sequential intravenous followed by oral ciprofloxacin with intravenous ceftazidime in the treatment of serious infections. Am J Med 1989; 87:185S-190S.
13. Sanders Jr. Efficacy, safety, and potential economic benefits of oral ciprofloxacin in the treatment of infections. Rev Infect Dis 1988; 10:528-543.
14. Hoffken G, Lode H, Prinzing C, et al. Pharmacokinetics of ciprofloxacin after oral and parenteral administration. Antimicrob Agents Chemother 1985; 27:375-379.
15. Solomkin JS, Dellinger EP, Christou NV, Busuttil RW. Results of a multicenter trial comparing imipenem/cilastatin to tobramycin/ clindamycin for intra-abdominal infections. Ann Surg 1990; 212: 581-591.
16. Hackford AW, Tally FP, Reinhold RB et al. Prospective study comparing imipenem-cilastatin with clindamycin and gentamicin for the treatment of serious surgical infections. Arch Surg 1988; 123:322-326.
17. Walker AP, Nichols RL, Wilson RF, et al. Efficacy of a beta-lactamase inhibitor combination for serious intraabdominal infections. Ann Surg 1993; 217:115-121.
18. National Committee for Clinical Laboratory Standards. Approved Standard M7-A2. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically. Villanova, PA: National Committee for Clinical Laboratory Standards; 1990.
19. National Committee for Clinical Laboratory Standards. Approved Standard M2-A4. Performance Standards for Antimicrobial Disk Susceptibility Tests. Villanova, PA: National Committee for Clinical Laboratory Standards; 1990.
20. National Committee for Clinical Laboratory Standards. Approved Standard M11-T2. Methods of Susceptibility Testing of Anaerobic Bacteria. Villanova, PA: National Committee for Clinical Laboratory Standards; 1988.
21. Solomkin JS, Hemsell DL, Sweet R, et al. Evaluation of new anti-infectious drugs for the treatment of intraabdominal infections: Infectious Diseases Society of America and the Food and Drug Administration. Clin Infect Dis 1992; 15:S33-S42.
22. Beam TR Jr, Gilbert DN, Kunin CM. General guidelines for the clinical evaluation of anti-infective drug products: Infectious Diseases Society of America and the Food and Drug Administration. Gin Infect Dis 1992; 15:S5-S32.
23. Muller EL, Pitt HA, Thompson JE Jr, et al. Antibiotics in infections of the biliary tract. Surg Gynecol Obstet 1987; 165:285-292.
24. Bohnen JM, Boulanger M, Meakins JL. Prognosis in generalized peritonitis. Arch Surg 1983; 118:285-290.
25. Brismar B, Malmborg AS, Tunevall G, et al. Piperacillin-tazobactam versus imipenem-cilastatin for treatment of intra-abdominal infections. Antimicrob Agents Chemother 1992; 36:2766-2773.
26. Nord CE. Meropenem versus Imipenem/Cilastatin for Treatment of Intraabdominal Infections: Report from a Swedish Study Group. Presented at the 33rd Interscience Conference on Antimicrobial Agents and Chemotherapy; 1993; New Orleans, LA. (abstract).
27. Wise R, Donovan IA, Lockley MR, et al. The pharmacokinetics and tissue penetration of imipenem. Antimicrob Agents Chemother 1986; 18:93-101.
28. Dan M, Serour F, Poch F. Penetration of ciprofloxacin into human peritoneal tissue following a single oral dose of 750 milligrams. Chemotherapy 1992; 4:27-29.
29. Dan M, Zuabi T, Quassem C, Rotmensch HH. Distribution of ciprofloxacin in ascitic fluid following administration of single oral dose of 750 milligrams. Antimicrob Agents Chemother 1992; 36: 677-678.
30. Barie PS, Christou NV, Dellinger EP, et al. Pathogenicity of the enterococcus in surgical infections. Ann Surg 1990; 21:155-159.
31. Ledergerber B, Bettex J, Joos B, et al. Effect of standard breakfast on drug absorption and multiple-dose pharmacokinetics of ciprofloxacin. Antimicrob Agents Chemother 1985; 27:350-352.
32. Frost RW, Lasseter KC, Noe AJ, et al. Effects of aluminum hydroxide and calcium carbonate antacids on the bioavailability of ciprofloxacin. Antimicrob Agents Chemother 1992; 36:830-832.
33. Solomkin JS, Meakins JL, Alto MD, et al. Antibiotic trials in intraabdominal infections: a critical evaluation of study design and outcome reporting. Ann Surg 1984; 200:29-39.
34. Solomkin JS, Dellinger EP, Christou NV, Mason ADJ. Design and conduct of antibiotic trials: a report of the Scientific Studies Committee of the Surgical Infection Society. Arch Surg 1987; 122:158-164.
35. Polk HC Jr, Fink MP, Laverdiere M, et al. Prospective randomized study of piperacillin/tazobactam therapy of surgically treated intra-abdominal infection: the Piperacillin/Tazobactam Intra-Abdominal Infection Study Group. Am Surg 1993; 59:598-605.
36. Sirinek KR, Levine BA. A randomized trial of ticarcillin and clavulanate versus gentamicin and clindamycin in patients with complicated appendicitis. Surg Gynecol Obstet 1991; 172:30-35.
37. Berne TV, Yellin AE, Appleman MD, et al. A clinical comparison of cefepime and metronidazole versus gentamicin and clindamycin in the antibiotic management of surgically treated advanced appendicitis. Surg Gynecol Obstet 1993; 177(suppl): 18-22.
38. Heseltine PNR, Yellin AE, Appleman MD, et al. Perforated and gangrenous appendicitis: an analysis of antibiotic failures. J Infect Dis 1983; 148:322-329.
39. Yellin AE, Heseltine PN, Berne TV, et al. The role of Pseudomonas species in patients treated with ampicillin and sulbactam for gangrenous and perforated appendicitis. Surg Gynecol Obstet 1985; 161:303-307.
40. Bennion RS, Baron EJ, Thompson JE, et al. The bacteriology of gangrenous and perforated appendicitis - revisited. Ann Surg 1990; 211:165-171.
41. Roberts JP. Quantitative bacterial flora of acute appendicitis. Arch Dis Child 1988; 63:536-540.
42. Gilbert DN, Beam TR Jr, Kunin CM. The path to new FDA guidelines for clinical evaluation of anti-infective drugs. Rev Infect Dis 1991; 13:S890-S894.
43. Beam TR Jr, Gilbert DN, Kunin CM. European guidelines for anti-infective drug products: introduction. Clin Infect Dis 1993; 17:787-788.