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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population [ Time Frame: 7 - 14 days after completion of study drug therapy ]

Original Primary Outcome:

• TOC visit (7-14 days after EOT). The primary efficacy analysis will be performed on the per protocol population
• Subjects will be included in the per protocol analysis if they satisfy the following criteria of a valid course
• The diagnosis of uncomplicated pelvic inflammatory disease must have been confirmed
• No other systemic antimicrobial agent (with the exception of one single dose of ceftriaxone in subjects with a gonococcal infection) was administered concomitantly with the study drug unless the subject was a treatment failure
• The study drug was given for a minimum of 72 hours (in case of clinical failure) or 8 full days (in case of success)
• Compliance with >= 80% of study medication administered, must be documented
• No protocol violations influencing the treatment efficacy must have been observed
• The clinical evaluation at TOC visit must be available and different from “indeterminate”
• The subject was not given an immunosuppressive therapy, and had no neutropenia (<1000/mm3), no HIV infection with CD4 count < 200/mm3, no AIDS-defining event, and was not under HAART
• Study blind must have been maintained.

Current Secondary Outcome:

• Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population [ Time Frame: 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".
• Clinical Response on Treatment for Per Protocol Population [ Time Frame: 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).
• Clinical Response on Treatment for Intent To Treat Population [ Time Frame: 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.
• Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid [ Time Frame: 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.
• Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism [ Time Frame: 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.
• Clinical Response at Follow-up Visit on Per Protocol Population [ Time Frame: 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.
• Clinical Response at Follow-up Visit on Intent To Treat Population [ Time Frame: 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.
• Bacteriological Response at Follow-up Visit Microbiologically Valid [ Time Frame: 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.
• Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism [ Time Frame: 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.
• Number of Subjects Who Received Alternative Medicine [ Time Frame: Up to 42 days after end of treatment ]
  As alternative medicine any systemic antibacterial medication was considered.

Original Secondary Outcome:

• Clinical response during treatment (4 to 7 days after start of treatment)
• Bacteriological response at the TOC visit (7-14 days after the end of treatment)
• Clinical and bacteriological response at the Follow-up visit (28 to 42 days post-therapy)
• Clinical response at the TOC visit in subjects with bacteriologically documented infection.

Information By: Bayer

Dates:
Date Received: March 27, 2007
Date Started: January 2007
Date Completion:
Last Updated: September 2, 2014
Last Verified: September 2014