Evidence map›Paper›PMID 16723364›Full record

Trial reportSexually transmitted infections2006

Moxifloxacin versus ofloxacin plus metronidazole in uncomplicated pelvic inflammatory disease: results of a multicentre, double blind, randomised trial.

J D C Ross, H S Cronjé, T Paszkowski, I Rakoczi, D Vildaite, A Kureishi, M Alefelder, P Arvis, P Reimnitz, MAIDEN Study Group

Open access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Sexually transmitted infections, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 7 pooled it
1.9field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 7 syntheses or guidelines pooled it, 65 citations in OpenAlex.

  1. Antibiotic therapy for pelvic inflammatory disease.The Cochrane database of systematic reviews · 2020
    Pooled it
  2. Pooled it
  3. Antibiotic therapy for pelvic inflammatory disease.The Cochrane database of systematic reviews · 2017
    Pooled it
  4. Sexually transmitted diseases treatment guidelines, 2015.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2015
    Guideline
  5. Pelvic inflammatory disease.BMJ clinical evidence · 2013
    Pooled it
  6. Pooled it
  7. Pelvic inflammatory disease.BMJ clinical evidence · 2008
    Pooled it
  8. Standard treatment regimens for nongonococcal urethritis have similar but declining cure rates: a randomized controlled trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2013
    Trial
  9. Systematic Review and Meta-analysis of the Association Between Mycoplasma genitalium and Pelvic Inflammatory Disease (PID).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  10. Article
  11. Mycoplasma genitalium: An Overlooked Sexually Transmitted Pathogen in Women?Infectious diseases in obstetrics and gynecology · 2016
    Review
  12. Gender analysis of moxifloxacin clinical trials.Journal of women's health (2002) · 2014
    Review
  13. Review
  14. Mycoplasma genitalium: should we treat and how?Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2011
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 5 countries.

J D C RossWhittall Street Clinic, Whittall Street, Birmingham B4 6DH, UK. jonathan.ross@hobtpct.nhs.uk
H S Cronjé
T Paszkowski
I Rakoczi
D Vildaite
A Kureishi
M Alefelder
P Arvis
P Reimnitz
MAIDEN Study Group
Bayer (Germany) · DEBayer (France) · FRMedical University of Lublin · PLSzent Imre Egyetemi Oktatókórház · HUUniversity of the Free State · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis 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.

methodsWomen 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).

resultsOf 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).

conclusionIn 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.

Indexed as

Administration, OralAdultAnti-Infective AgentsAza CompoundsDouble-Blind MethodDrug Therapy, CombinationFemaleFluoroquinolonesHumansMetronidazoleMoxifloxacinOfloxacinPainPain MeasurementPelvic Inflammatory DiseaseProspective StudiesAnti-Infective AgentsAza CompoundsFluoroquinolonesMetronidazoleMoxifloxacinOfloxacinQuinolines

Identifiers

PMID16723364
PMCPMC2563874
OpenAlexW2049559774

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.