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

Pelvic Inflammatory Disease Clinical Trial

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 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453349
• Other study ID #: 11981
• Secondary ID: 2006-000874-56
• Status: Completed
• Phase: Phase 3
• First received: March 27, 2007
• Last updated: September 2, 2014
• Start date: January 2007
• Est. completion date: May 2008

Study information

• Verified date: September 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Inflammatory Disease

Intervention

Drug:
• Moxifloxacin (Avelox, BAY12-8039)
Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
• Levofloxacin & Metronidazole
Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

China,  Indonesia,  Korea, Republic of,  Pakistan,  Philippines,  Taiwan,  Thailand, 

References & Publications (1)

Judlin P, Liao Q, Liu Z, Reimnitz P, Hampel B, Arvis P. Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study. BJOG. 2010 Nov;117(12):1475-84. doi: 10.1111/j.1471-0528.2010.02687.x. Epub 2010 Aug 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Clinical Response at Follow-up Visit on Intent To Treat 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 treated as non-successes.	28 - 42 days after completion of study drug therapy	No
Secondary	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	No
Secondary	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	No
Secondary	Number of Subjects Who Received Alternative Medicine	As alternative medicine any systemic antibacterial medication was considered.	Up to 42 days after end of treatment	No

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