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PMID: 3286511 Published · ppublish English Clinical Trial Journal Article Review

Worldwide clinical data on efficacy and safety of ciprofloxacin.

Infection ·Vol. 16 Suppl 1 ·1988-00-00 ·Pages S29-43

Schacht P, Arcieri G, Branolte J, Bruck H, Chyský V, Griffith E, Gruenwaldt G, Hullmann R, Konopka CA, O'Brien B

Abstract

During the clinical trials 8,861 patients have been treated with ciprofloxacin worldwide. 3,822 of the therapeutic courses were valid for analysis of efficacy according to FDA standards. The following dosages were usually administered: UTI: 100 to 500 mg twice daily orally or 100 mg twice daily intravenously; RTI: 250 to 1000 mg twice daily orally or 200 mg twice daily intravenously; septicemia: 200 mg intravenously twice daily; gonorrhea: 250 to 500 mg single tablet orally; all other infections: 500 to 1000 mg twice daily orally or 200 mg twice daily intravenously. Ciprofloxacin was administered to 762 courses of lower RTI, 88 courses of upper RTI, 108 courses of bacteremia, 766 courses of skin structure infection, 142 courses of bone and joint infections, 149 courses of intra-abdominal infections, 33 courses of gastrointestinal infections, 1,633 courses of UTI, 49 courses of pelvic infections, 279 courses of STD, mainly gonorrhea, and three courses of meningitis. The clinical response was resolution in 76%, improvement in 18% and failure in only 6%. Bacteriologic response by all sites evaluable: pathogens were eradicated from 74%, markedly reduced in 2%, persisted in 10%. Relapse occurred in 4% and reinfection was observed in another 6%. The overall response was favourable for 90% of the patients. Drug safety was established on a data base of 8,861 courses worldwide. The following side-effects according to COSTART terminology were observed: digestive 5%, metabolic nutritional 4.6%, central nervous 1.6%, skin 1.4%, hemic and lymphatic 1%, cardiovascular 0.4%, body as a whole 0.4%, urogenital 0.3%, special senses 0.3%, musculo-skeletal 0.1%, respiratory 0.08%. Several courses had more than one reaction. Thus the total incidence of side-effects for the treated patient population was 10.2%. Ciprofloxacin is a highly effective drug and a breakthrough in several areas of medical interest. It is relatively safe and side-effects are usually mild or moderate in intensity and transient.

MeSH Terms
Bacterial Infections/drug therapy Ciprofloxacin/therapeutic use,toxicity Clinical Trials as Topic Female Humans Male
Chemicals
Ciprofloxacin
Authors & Affiliations
10 authors, click to expand affiliations / ORCID
Schacht P
Bayer AG, Pharma Forschungszentrum, Wuppertal 1.
Arcieri G
Branolte J
Bruck H
Chyský V
Griffith E
Gruenwaldt G
Hullmann R
Konopka C A
O'Brien B
References (52)
52 references, click to expand
  1. Dose- and sex-independent disposition of ciprofloxacin.
    Eur J Clin Microbiol. 1984 Aug;3(4):363-6 PMID: 6489328
  2. Oral ciprofloxacin compared with conventional intravenous treatment for Pseudomonas aeruginosa infection in adults with cystic fibrosis.
    Lancet. 1987 Jan 31;1(8527):235-7 PMID: 2880066
  3. Ciprofloxacin for soft tissue infections.
    J Antimicrob Chemother. 1986 Nov;18 Suppl D:159-64 PMID: 3804904
  4. Comparative clinical efficacy of two different single-dose ciprofloxacin treatments for uncomplicated gonorrhea.
    Sex Transm Dis. 1986 Jul-Sep;13(3):169-71 PMID: 3764628
  5. Treatment of chronic salmonella carriers with ciprofloxacin.
    Eur J Clin Microbiol. 1986 Apr;5(2):260-1 PMID: 2941298
  6. Oral ciprofloxacin therapy of infection caused by multiply resistant bacteria other than Pseudomonas aeruginosa.
    J Antimicrob Chemother. 1986 Nov;18 Suppl D:179-85 PMID: 3804906
  7. Comparison of intravenous ciprofloxacin and mezlocillin in treatment of complicated urinary tract infection.
    Eur J Clin Microbiol. 1986 Apr;5(2):253-5 PMID: 2941295
  8. In vitro activity of Bay 09867, a new quinoline derivative, compared with those of other antimicrobial agents.
    Antimicrob Agents Chemother. 1983 Apr;23(4):559-64 PMID: 6222695
  9. Ciprofloxacin, a quinolone carboxylic acid compound active against aerobic and anaerobic bacteria.
    Antimicrob Agents Chemother. 1984 Mar;25(3):319-26 PMID: 6232895
  10. Tissue distribution of ciprofloxacin following oral and intravenous administration.
    Infection. 1985 Mar-Apr;13(2):78-81 PMID: 3158611
  11. Ciprofloxacin in the treatment of urinary tract infections caused by Pseudomonas aeruginosa and multiresistant bacteria.
    Eur J Clin Microbiol. 1986 Apr;5(2):255-7 PMID: 2941296
  12. A comparative study of ciprofloxacin and trimethoprim in the treatment of urinary tract infections in geriatric patients.
    J Antimicrob Chemother. 1986 Nov;18 Suppl D:111-5 PMID: 3542942
  13. Quinolones in the treatment of gonorrhoea and Chlamydia trachomatis infections.
    Pharm Weekbl Sci. 1986 Feb 21;8(1):60-2 PMID: 3515313
  14. Pharmacokinetics of ciprofloxacin after intravenous and increasing oral doses.
    Eur J Clin Microbiol. 1986 Apr;5(2):187-92 PMID: 2941278
  15. Successful treatment with ciprofloxacin of Salmonella typhimurium infection in an immunocompromised host.
    Infection. 1985 Nov-Dec;13(6):288 PMID: 2934339
  16. Multiple-dose ciprofloxacin kinetics in normal subjects.
    Clin Pharmacol Ther. 1984 Sep;36(3):384-8 PMID: 6467798
  17. The in vitro and in vivo activity of ciprofloxacin.
    Eur J Clin Microbiol. 1984 Aug;3(4):339-43 PMID: 6237902
  18. Chloramphenicol-resistant Salmonella tennessee osteomyelitis.
    Infection. 1984 Sep-Oct;12(5):359 PMID: 6511092
  19. In vitro activity of ciprofloxacin, norfloxacin and nalidixic acid.
    Eur J Clin Microbiol. 1983 Apr;2(2):111-5 PMID: 6222896
  20. Comparative, double-blind study of oral ciprofloxacin and intravenous cefotaxime in skin and skin structure infections.
    Am J Med. 1987 Apr 27;82(4A):220-3 PMID: 3555040
  21. Pharmacokinetics of ciprofloxacin in peripheral lymph and skin blisters.
    Eur J Clin Microbiol. 1986 Aug;5(4):458-61 PMID: 3758057
  22. Ciprofloxacin concentrations in tonsils following a single intravenous infusion.
    Infection. 1984 Sep-Oct;12(5):355-7 PMID: 6511090
  23. Overview of clinical experience with ciprofloxacin.
    Eur J Clin Microbiol. 1986 Apr;5(2):214-9 PMID: 3013631
  24. Ciprofloxacin in acute male gonorrhea.
    Arzneimittelforschung. 1986 Dec;36(12):1840-2 PMID: 3566847
  25. In-vitro studies with ciprofloxacin, a new 4-quinolone compound.
    J Antimicrob Chemother. 1984 Apr;13(4):333-46 PMID: 6233250
  26. Pharmacokinetics of ciprofloxacin and effect of repeated dosage on salivary and fecal microflora.
    Antimicrob Agents Chemother. 1986 Feb;29(2):298-302 PMID: 2940965
  27. Penetration of ciprofloxacin into gynecological tissues following oral and intravenous administration.
    Chemotherapy. 1986;32(1):7-17 PMID: 2936582
  28. Ciprofloxacin in the treatment of urinary and respiratory tract infections in patients with chronic liver disease.
    Chemioterapia. 1986 Oct;5(5):322-6 PMID: 3791479
  29. Pharmacokinetics of intravenously administered ciprofloxacin.
    Antimicrob Agents Chemother. 1984 Aug;26(2):208-10 PMID: 6486762
  30. [A cross-over study on the effectiveness of ofloxacin and ciprofloxacin administered orally].
    Infection. 1986;14 Suppl 1:S82-6 PMID: 2937740
  31. Pharmacokinetics of single dose intravenous ciprofloxacin in patients undergoing gastrointestinal surgery.
    J Antimicrob Chemother. 1986 Jul;18(1):107-12 PMID: 2944864
  32. Ciprofloxacin in the treatment of acute bacterial diarrhea: a double blind study.
    Eur J Clin Microbiol. 1986 Apr;5(2):241-3 PMID: 2941290
  33. Pharmacokinetics of ciprofloxacin after oral and parenteral administration.
    Antimicrob Agents Chemother. 1985 Mar;27(3):375-9 PMID: 3158275
  34. [Ciprofloxacin in Salmonella infection and abdominal typhoid].
    Dtsch Med Wochenschr. 1986 Oct 17;111(42):1599-602 PMID: 3769803
  35. Experience with ciprofloxacin in the treatment of various infections caused mainly by Pseudomonas aeruginosa.
    Drugs Exp Clin Res. 1985;11(5):351-6 PMID: 2941264
  36. Treatment of uncomplicated gonococcal urethritis in men with two dosages of ciprofloxacin.
    Eur J Clin Microbiol. 1986 Apr;5(2):244-6 PMID: 2941291
  37. Antibacterial activities of ciprofloxacin, norfloxacin, oxolinic acid, cinoxacin, and nalidixic acid.
    Antimicrob Agents Chemother. 1984 May;25(5):633-7 PMID: 6233935
  38. Ciprofloxacin in the treatment of Pseudomonas infection in cystic fibrosis patients.
    J Antimicrob Chemother. 1986 Nov;18 Suppl D:147-52 PMID: 3100490
  39. Concentrations of ciprofloxacin in serum and prostatic tissue in patients undergoing transurethral resection.
    Eur J Clin Microbiol. 1986 Apr;5(2):211-2 PMID: 2424755
  40. Ciprofloxacin: an overview of adverse experiences.
    J Antimicrob Chemother. 1986 Nov;18 Suppl D:187-93 PMID: 3542945
  41. Multiple-dose pharmacokinetics and safety of ciprofloxacin in normal volunteers.
    Antimicrob Agents Chemother. 1984 Nov;26(5):741-4 PMID: 6517556
  42. Clinical experience with ciprofloxacin in the USA.
    Eur J Clin Microbiol. 1986 Apr;5(2):220-5 PMID: 2941286
  43. Multiple-dose pharmacokinetics of ciprofloxacin administered intravenously to normal volunteers.
    Antimicrob Agents Chemother. 1985 Aug;28(2):235-9 PMID: 2939794
  44. Open, prospective study of the clinical efficacy of ciprofloxacin.
    Antimicrob Agents Chemother. 1985 Jul;28(1):128-32 PMID: 2931046
  45. Treatment of skin and soft tissue infections with oral ciprofloxacin.
    J Antimicrob Chemother. 1986 Nov;18 Suppl D:153-7 PMID: 3804903
  46. Ciprofloxacin in the treatment of urinary tract infection due to enterobacteria.
    Eur J Clin Microbiol. 1986 Apr;5(2):247-8 PMID: 2941292
  47. Quinolones in chest infections.
    J Antimicrob Chemother. 1986 Sep;18(3):296-9 PMID: 3533884
  48. Ciprofloxacin and co-trimoxazole in urinary tract infection.
    J Antimicrob Chemother. 1986 Nov;18 Suppl D:107-10 PMID: 3492487
  49. Ciprofloxacin pharmacokinetics in patients with cystic fibrosis.
    Infection. 1986 Jan-Feb;14(1):17-21 PMID: 2937737
  50. Diffusion of ciprofloxacin into prostatic fluid.
    Eur J Clin Microbiol. 1984 Aug;3(4):360-2 PMID: 6489327
  51. New 4-quinolones in the treatment of urinary tract infections.
    Pharm Weekbl Sci. 1986 Feb 21;8(1):46-52 PMID: 2938070
  52. Pharmacokinetics of ciprofloxacin in healthy volunteers after oral and intravenous administration.
    Eur J Clin Microbiol. 1986 Apr;5(2):179-86 PMID: 2941277
Article Info
Journal
Infection
Abbr.
Infection
ISSN
0300-8126
DOI
10.1007/BF01650504
Published
1988-00-00
Pages
S29-43
Language
English
Region
Germany
NLM ID
0365307
Subset
IM
External Links
PubMed source DOI: 10.1007/BF01650504 View journal details
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