- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01799356
Moxifloxacin Versus Ofloxacin Plus Metronidazole in Uncomplicated Pelvic Inflammatory Disease: Multicenter Randomized Controlled Trials
August 27, 2013 updated by: Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
We aimed to compare efficacy and safety of combination therapy with oral ofloxacin, 400 mg twice daily, plus oral metronidazole, 500 mg twice daily, for 14 days, with moxifloxacin monotherapy, 400 mg once daily, for 14 days
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1303
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Mardin, Turkey, 47000
- T.C.S.B Mardin Women and Children Hospital
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Şişli, Turkey, 34150
- T.C.S.B. Şişli Etfal Training Research Hospital
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Fatih
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Samatya, Fatih, Turkey, 34180
- T.C.S.B. İstanbul Training Research Hospital
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Kucukcekmece
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İstanbul, Kucukcekmece, Turkey, 34280
- T.C.S.B. Kanuni Sultan Suleyman Training Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 43 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women diagnosed uncomplicated PID
- Patients age are between 14 with 45
- Pelvic tenderness and vaginal discharge
Exclusion Criteria:
- Urinary Tract Enfections
- Tubo-ovarian abscess and complicated PID
- Hıstory of antibiotics treatment
- Other pelvic pain causes
- Endometriosis
- Delivery,abortion and surgery within last months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: moxifloxacin Group
Treatment at uPID with moxifloxacin
|
daily 400 mg moksifloksasin
Other Names:
|
Placebo Comparator: Ofloxacin Group
Treatment at uPID with Ofloxacin plus metronidazole
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daily 800 mg oflaksasin plus 1000 mg metronidazol treatment
Other Names:
daily 1000 mg metronidazol plus 800 mg oflaksasin treatment for uPID
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinically cure
Time Frame: 21 Days
|
21 Days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Microbiological cure
Time Frame: 21 Days
|
21 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Kemal Gungorduk, md, T.C.S.B. Kanıni Sultan Suleyman Training Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Boothby M, Page J, Pryor R, Ross JD. A comparison of treatment outcomes for moxifloxacin versus ofloxacin/metronidazole for first-line treatment of uncomplicated non-gonococcal pelvic inflammatory disease. Int J STD AIDS. 2010 Mar;21(3):195-7. doi: 10.1258/ijsa.2009.009374.
- Savaris RF, Fuhrich DG, Maissiat J, Duarte RV, Ross J. Antibiotic therapy for pelvic inflammatory disease. Cochrane Database Syst Rev. 2020 Aug 20;8(8):CD010285. doi: 10.1002/14651858.CD010285.pub3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
February 16, 2013
First Submitted That Met QC Criteria
February 23, 2013
First Posted (Estimate)
February 26, 2013
Study Record Updates
Last Update Posted (Estimate)
August 28, 2013
Last Update Submitted That Met QC Criteria
August 27, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Adnexal Diseases
- Pelvic Inflammatory Disease
- Pelvic Infection
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Antitubercular Agents
- Cytochrome P-450 CYP1A2 Inhibitors
- Anti-Infective Agents, Urinary
- Renal Agents
- Moxifloxacin
- Metronidazole
- Anti-Bacterial Agents
- Antibiotics, Antitubercular
- Ofloxacin
Other Study ID Numbers
- Asicioglu03
- treatment (treatment pelvic inflammatuary disease)
- treatment uPID (Other Identifier: we aimed this study treatment uPID)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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