Trial · NCT00453349

A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease

NCT00453349, Phase 3, Completed, Bayer; results first posted 2009-11-30

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease. Trials, record NCT00453349. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00453349

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease
NCT number: NCT00453349
Status: Completed
Phases: Phase 3
Enrollment: 460 participants, actual
Lead sponsor: Bayer
Conditions: Pelvic Inflammatory Disease
Interventions: Moxifloxacin (Avelox, BAY12-8039), Levofloxacin & Metronidazole
First posted: 2007-03-28
Last updated: 2014-09-08
Other registries' IDs: eudract:2006-000874-56
Results first posted: 2009-11-30
Limitations and caveats: Out of the 460 randomized subjects, 5 subjects (3 moxifloxacin subjects, 2 placebo subjects) did not receive any study medication. Only one of these patients had an adverse event (stomachache, randomized to Moxifloxacin).

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population	7 - 14 days after completion of study drug therapy	Clinical cure was defined as: Reduction of the tenderness score (modified McCormack) by \> 70% and apyrexia (rectal/tympanic/oral temperature value \< 38.0°C or axillary temperature value \< 37.5°C) and white blood cell count \< 10,500/mm\^3.
Secondary	Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population	7 - 14 days after completion of study drug therapy	For any subject in the ITT population also valid for the PP analysis, same clinical response as in the PP analysis was applied to the ITT analysis. For those subjects in the ITT population invalid for the PP analysis, any clinical response different from clinical cure was set to "non-success".
Secondary	Clinical Response on Treatment for Per Protocol Population	4 - 7 days after start of therapy	At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement (severity score reduced by \>30% with improvement in temperature, clinical failure (reduction in severity score of \< or equal 30% and/or no improvement in temperature) or indeterminate (clinical assessment not possible to determine).
Secondary	Clinical Response on Treatment for Intent To Treat Population	4 - 7 days after start of therapy	Clinical response during treatment was analyzed exploratively in the same way as the primary efficacy variable. At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement, clinical failure or indeterminate accordingly. Clinical improvement was considered success, all other outcomes as non-success.
Secondary	Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid	7 - 14 days at TOC visit	The bacteriological responses was based on the results of appropriate cultures taken before and, if necessary, during treatment, at the TOC visit and within the follow-up period. Bacteriological response at the TOC visit would also be based on repeated PCR tests for N. gonorrhoeae and C. trachomatis.
Secondary	Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism	7 - 14 days at TOC visit	Bacteriological response at the TOC was analyzed exploratively in the same way as the primary efficacy variable based on the subgroup of microbiologically valid subjects. At the TOC visit, eradication was considered a bacteriological success, and persistence, presumed persistence and superinfection were considered bacteriological failures.
Secondary	Clinical Response at Follow-up Visit on Per Protocol Population	28 - 42 days after completion of study drug therapy	Clinical response at follow up was analyzed exploratively in the same way as the primary efficacy variable. At Follow-up, the clinical response was graded as continued cure, clinical relapse, or indeterminate, of which only continued cure was considered success. Failures from end of treatment were carried forward.
Secondary	Clinical Response at Follow-up Visit on Intent To Treat Population	28 - 42 days after completion of study drug therapy	All successfully treated subjects and subjects evaluated as"indeterminate" at TOC, who were not administered an additional antibiotic therapy would have their clinical response rate assessed at the follow-up visit. Patients with missing or indeterminate outcome were treated as non-successes.
Secondary	Bacteriological Response at Follow-up Visit Microbiologically Valid	28 - 42 days after completion of study drug therapy	Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.
Secondary	Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism	28 - 42 days after completion of study drug therapy	Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population	7 - 14 days after completion of study drug therapy	The number of subjects in the PP population was slightly higher than the planned number of subjects (184 subjects per treatment group). The most common reasons for exclusion from the population valid for efficacy in both the Moxifloxacin and Comparator were essential data missing/invalid, followed by violation of inclusion/exclusion criteria.	participants	NUMBER
SECONDARY	Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population	7 - 14 days after completion of study drug therapy	Subjects who were randomized, had received at least one dose of study medication and had at least one observation after drug intake would be included in the ITT analysis.	participants	NUMBER
SECONDARY	Clinical Response on Treatment for Per Protocol Population	4 - 7 days after start of therapy	Analysis was performed for the per protocol population.	participants	NUMBER
SECONDARY	Clinical Response on Treatment for Intent To Treat Population	4 - 7 days after start of therapy	Subjects who were randomized, had received at least one dose of study medication and had at least one observation after drug intake would be included in the ITT analysis. For any subject in the ITT population also valid for the PP analysis, same clinical response as in the PP analysis was applied to the ITT analysis.	participants	NUMBER
SECONDARY	Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid	7 - 14 days at TOC visit	All subjects for whom a specific bacterial pathogen was isolated/identified from any pre-treatment culture and which was considered responsible for the infection would be assessed for bacteriological efficacy.	participants	NUMBER
SECONDARY	Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism	7 - 14 days at TOC visit	Patients were included in this analysis if a causative organism could be established pre-therapy by culture or PCR, and if the patient was valid for intent-to-treat.	participants	NUMBER
SECONDARY	Clinical Response at Follow-up Visit on Per Protocol Population	28 - 42 days after completion of study drug therapy	All successfully treated subjects and subjects evaluated as indeterminate at TOC, who were not administered an additional antibiotic therapy would have their clinical response rate assessed at the follow up visit. Patients with missing or indeterminate outcome were omitted.	participants	NUMBER
SECONDARY	Clinical Response at Follow-up Visit on Intent To Treat Population	28 - 42 days after completion of study drug therapy	At the follow-up visit, the clinical response in subjects who were non-failures at the TOC visit were graded as Continued cure, Clinical relapse or Indeterminate.	participants	NUMBER
SECONDARY	Bacteriological Response at Follow-up Visit Microbiologically Valid	28 - 42 days after completion of study drug therapy	At the follow-up visit, the bacteriological success response was classified as eradication, and recurrence/persistence as bacteriological failures.	participants	NUMBER
SECONDARY	Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism	28 - 42 days after completion of study drug therapy	At the follow-up visit, the bacteriological success response was classified as Eradication, and recurrence/persistence as bacteriological failures.	participants	NUMBER

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group44

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population	Moxifloxacin	Clinical cure	152	participants
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population	Levofloxacin Plus Metronidazole	Clinical cure	155	participants
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population	Moxifloxacin	Clinical non-success	42	participants
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population	Levofloxacin Plus Metronidazole	Clinical non-success	35	participants
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population	Moxifloxacin	Clinical cure	163	participants
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population	Levofloxacin Plus Metronidazole	Clinical cure	171	participants
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population	Moxifloxacin	Clinical non-success	62	participants
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population	Levofloxacin Plus Metronidazole	Clinical non-success	59	participants
Clinical Response on Treatment for Per Protocol Population	Moxifloxacin	Clinical Improvement	177	participants
Clinical Response on Treatment for Per Protocol Population	Levofloxacin Plus Metronidazole	Clinical Improvement	181	participants

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow22

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Randomized	STARTED	Moxifloxacin	228
Randomized	STARTED	Levofloxacin Plus Metronidazole	232
Randomized	COMPLETED	Moxifloxacin	203
Randomized	COMPLETED	Levofloxacin Plus Metronidazole	209
Randomized	NOT COMPLETED	Moxifloxacin	25
Randomized	NOT COMPLETED	Levofloxacin Plus Metronidazole	23
Reaching of Primary Endpoint (TOC)	STARTED	Moxifloxacin	225
Reaching of Primary Endpoint (TOC)	STARTED	Levofloxacin Plus Metronidazole	230
Reaching of Primary Endpoint (TOC)	Valid for Primary Efficacy Analysis	Moxifloxacin	194
Reaching of Primary Endpoint (TOC)	Valid for Primary Efficacy Analysis	Levofloxacin Plus Metronidazole	190

1 to 10 of 22Source ClinicalTrials.gov

See all 22 participant flow

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain upper	Gastrointestinal disorders	Moxifloxacin	10	225
other	Abdominal pain upper	Gastrointestinal disorders	Levofloxacin Plus Metronidazole	14	230
other	Nausea	Gastrointestinal disorders	Moxifloxacin	43	225
other	Nausea	Gastrointestinal disorders	Levofloxacin Plus Metronidazole	54	230
other	Vomiting	Gastrointestinal disorders	Moxifloxacin	7	225
other	Vomiting	Gastrointestinal disorders	Levofloxacin Plus Metronidazole	15	230
other	Dizziness	Nervous system disorders	Moxifloxacin	39	225
other	Dizziness	Nervous system disorders	Levofloxacin Plus Metronidazole	36	230
other	Insomnia	Psychiatric disorders	Moxifloxacin	7	225
other	Insomnia	Psychiatric disorders	Levofloxacin Plus Metronidazole	14	230

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Moxifloxacin
Total, all-cause mortality	Levofloxacin Plus Metronidazole
Total, other adverse events	Moxifloxacin	83	225
Total, other adverse events	Levofloxacin Plus Metronidazole	94	230
Total, serious adverse events	Moxifloxacin	3	225
Total, serious adverse events	Levofloxacin Plus Metronidazole	1	230

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20716255	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Moxifloxacin vs Levofloxacin Plus Metronidazole: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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