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

Study Overview
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Brief Summary
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To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus oral metronidazole in uncomplicated pelvic inflammatory disease (PID)

Official Title
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A Prospective, Randomized, Double Dummy, Double Blind, Multi-center Multinational Trial Comparing the Efficacy and Safety of Moxifloxacin 400 mg PO QD 24 Hours for 14 Days to That of Levofloxacin 500 mg PO QD 24 Hours Plus Metronidazole 500 mg BID for 14 Days in Subjects With an Uncomplicated Pelvic Inflammatory Disease (PID). Moxifloxacin, Metronidazole, and Levofloxacin in Asia (MONALISA Study)

Conditions
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Pelvic Inflammatory Disease

Intervention / Treatment
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* Drug: Moxifloxacin (Avelox, BAY12-8039)
* Drug: Levofloxacin & Metronidazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of uncomplicated PID based on the absence of pelvic or tubo-ovarian abscess at pelvic ultrasound and/or laparoscopic examination. Exclusion Criteria: Subjects with impaired liver and renal function; known hypersensitivity to study drugs, related compounds or any of the excipients.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxifloxacin<br>Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days | Drug: Moxifloxacin (Avelox, BAY12-8039)<br>* Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days<br>|
| Active Comparator: Levofloxacin plus Metronidazole<br>Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days | Drug: Levofloxacin & Metronidazole<br>* Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population | 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. | 7 - 14 days after completion of study drug therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population | 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. | 7 - 14 days after completion of study drug therapy | 
| Clinical Response on Treatment for Per Protocol Population | 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). | 4 - 7 days after start of therapy | 
| Clinical Response on Treatment for Intent To Treat Population | 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. | 4 - 7 days after start of therapy | 
| Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid | 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. | 7 - 14 days at TOC visit | 
| Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism | 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. | 7 - 14 days at TOC visit | 
| Clinical Response at Follow-up Visit on Per Protocol Population | 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. | 28 - 42 days after completion of study drug therapy | 
| Clinical Response at Follow-up Visit on Intent To Treat Population | All successfully treated subjects and subjects evaluated asindeterminate 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. | 28 - 42 days after completion of study drug therapy | 
| Bacteriological Response at Follow-up Visit Microbiologically Valid | 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. | 28 - 42 days after completion of study drug therapy | 
| Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism | 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. | 28 - 42 days after completion of study drug therapy | 
| Number of Subjects Who Received Alternative Medicine | As alternative medicine any systemic antibacterial medication was considered. | Up to 42 days after end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uncomplicated pelvic inflammatory disease