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

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.

Time frame: 7 - 14 days after completion of study drug therapy

Population: 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.

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.

Time frame: 28 - 42 days after completion of study drug therapy

Population: At the follow-up visit, the bacteriological success response was classified as Eradication, and recurrence/persistence as bacteriological failures.

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.

Time frame: 28 - 42 days after completion of study drug therapy

Population: At the follow-up visit, the bacteriological success response was classified as eradication, and recurrence/persistence as bacteriological failures.

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.

Time frame: 7 - 14 days at TOC visit

Population: 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.

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.

Time frame: 7 - 14 days at TOC visit

Population: 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.

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.

Time frame: 7 - 14 days after completion of study drug therapy

Population: 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.

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.

Time frame: 28 - 42 days after completion of study drug therapy

Population: 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.

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.

Time frame: 28 - 42 days after completion of study drug therapy

Population: 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.

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.

Time frame: 4 - 7 days after start of therapy

Population: 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.

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).

Time frame: 4 - 7 days after start of therapy

Population: Analysis was performed for the per protocol population.

As alternative medicine any systemic antibacterial medication was considered.

Time frame: Up to 42 days after end of treatment

Population: The number of subjects who received alternative medicine in the PP population was analyzed. The clinical response was graded as alternative medicine (clinical cure, improvement, continued clinical cure) versus no alternative medicine.