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Moxifloxacin versus ofloxacin plus metronidazole in uncomplicated pelvic inflammatory disease: results of a multicentre, double blind, randomised trial.
Sex Transm Infect. 2006 Dec; 82(6):446-51.ST

Abstract

OBJECTIVE

This multinational, multicentre, prospective, randomised, double blind, parallel group, non-inferiority study compared the efficacy and safety of moxifloxacin monotherapy with ofloxacin plus metronidazole in women with uncomplicated pelvic inflammatory disease.

METHODS

Women from hospitals throughout 13 countries received a 14 day course of either oral moxifloxacin, 400 mg once daily (n = 384), or oral ofloxacin, 400 mg twice daily plus oral metronidazole, 500 mg twice daily (n = 365).

RESULTS

Of the 741 patients in the intent to treat (ITT) population, 564 (74.2%) were valid for the per protocol (PP) analyses; 112 (19.9%) of these were included in the microbiologically valid population (MBV). Clinical resolution rates in the PP population at the test of cure visit (TOC, 5-24 days post-therapy, primary efficacy end point) were 90.2% (248/275) for moxifloxacin and 90.7% (262/289) for ofloxacin plus metronidazole (95% CI: -5.7% to 4.0%). At follow up (28-42 days post-therapy), resolution rates in the PP population were 85.8% (236/275) and 87.9% (254/289) for moxifloxacin and comparator, respectively (95% CI: -8.0% to 3.1%). Bacteriological success rates in the MBV population at TOC were 87.5% (49/56) for moxifloxacin and 82.1% (46/56) for comparator (95% CI: -8.3% to 18.8%). Against Chlamydia trachomatis and Neisseria gonorrhoeae, bacteriological success rates with moxifloxacin were 88.5% (23/26) and 100% (13/13) and for comparator 85.7% (18/21) and 81.8% (18/22), respectively. Drug related adverse events occurred less frequently with moxifloxacin (22.5% (85/378)) versus the comparator (30.9% (112/363)) (p = 0.01).

CONCLUSION

In uncomplicated PID, once daily moxifloxacin monotherapy was clinically and bacteriologically as efficacious as twice daily ofloxacin plus metronidazole therapy and was associated with fewer drug related adverse events.

Authors+Show Affiliations

Whittall Street Clinic, Whittall Street, Birmingham B4 6DH, UK. jonathan.ross@hobtpct.nhs.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16723364

Citation

Ross, J D C., et al. "Moxifloxacin Versus Ofloxacin Plus Metronidazole in Uncomplicated Pelvic Inflammatory Disease: Results of a Multicentre, Double Blind, Randomised Trial." Sexually Transmitted Infections, vol. 82, no. 6, 2006, pp. 446-51.
Ross JD, Cronjé HS, Paszkowski T, et al. Moxifloxacin versus ofloxacin plus metronidazole in uncomplicated pelvic inflammatory disease: results of a multicentre, double blind, randomised trial. Sex Transm Infect. 2006;82(6):446-51.
Ross, J. D., Cronjé, H. S., Paszkowski, T., Rakoczi, I., Vildaite, D., Kureishi, A., Alefelder, M., Arvis, P., & Reimnitz, P. (2006). Moxifloxacin versus ofloxacin plus metronidazole in uncomplicated pelvic inflammatory disease: results of a multicentre, double blind, randomised trial. Sexually Transmitted Infections, 82(6), 446-51.
Ross JD, et al. Moxifloxacin Versus Ofloxacin Plus Metronidazole in Uncomplicated Pelvic Inflammatory Disease: Results of a Multicentre, Double Blind, Randomised Trial. Sex Transm Infect. 2006;82(6):446-51. PubMed PMID: 16723364.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Moxifloxacin versus ofloxacin plus metronidazole in uncomplicated pelvic inflammatory disease: results of a multicentre, double blind, randomised trial. AU - Ross,J D C, AU - Cronjé,H S, AU - Paszkowski,T, AU - Rakoczi,I, AU - Vildaite,D, AU - Kureishi,A, AU - Alefelder,M, AU - Arvis,P, AU - Reimnitz,P, AU - ,, Y1 - 2006/05/24/ PY - 2006/5/26/pubmed PY - 2007/1/12/medline PY - 2006/5/26/entrez SP - 446 EP - 51 JF - Sexually transmitted infections JO - Sex Transm Infect VL - 82 IS - 6 N2 - OBJECTIVE: This multinational, multicentre, prospective, randomised, double blind, parallel group, non-inferiority study compared the efficacy and safety of moxifloxacin monotherapy with ofloxacin plus metronidazole in women with uncomplicated pelvic inflammatory disease. METHODS: Women from hospitals throughout 13 countries received a 14 day course of either oral moxifloxacin, 400 mg once daily (n = 384), or oral ofloxacin, 400 mg twice daily plus oral metronidazole, 500 mg twice daily (n = 365). RESULTS: Of the 741 patients in the intent to treat (ITT) population, 564 (74.2%) were valid for the per protocol (PP) analyses; 112 (19.9%) of these were included in the microbiologically valid population (MBV). Clinical resolution rates in the PP population at the test of cure visit (TOC, 5-24 days post-therapy, primary efficacy end point) were 90.2% (248/275) for moxifloxacin and 90.7% (262/289) for ofloxacin plus metronidazole (95% CI: -5.7% to 4.0%). At follow up (28-42 days post-therapy), resolution rates in the PP population were 85.8% (236/275) and 87.9% (254/289) for moxifloxacin and comparator, respectively (95% CI: -8.0% to 3.1%). Bacteriological success rates in the MBV population at TOC were 87.5% (49/56) for moxifloxacin and 82.1% (46/56) for comparator (95% CI: -8.3% to 18.8%). Against Chlamydia trachomatis and Neisseria gonorrhoeae, bacteriological success rates with moxifloxacin were 88.5% (23/26) and 100% (13/13) and for comparator 85.7% (18/21) and 81.8% (18/22), respectively. Drug related adverse events occurred less frequently with moxifloxacin (22.5% (85/378)) versus the comparator (30.9% (112/363)) (p = 0.01). CONCLUSION: In uncomplicated PID, once daily moxifloxacin monotherapy was clinically and bacteriologically as efficacious as twice daily ofloxacin plus metronidazole therapy and was associated with fewer drug related adverse events. SN - 1368-4973 UR - https://www.unboundmedicine.com/medline/citation/16723364/Moxifloxacin_versus_ofloxacin_plus_metronidazole_in_uncomplicated_pelvic_inflammatory_disease:_results_of_a_multicentre_double_blind_randomised_trial_ L2 - https://sti.bmj.com/lookup/pmidlookup?view=long&pmid=16723364 DB - PRIME DP - Unbound Medicine ER -