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NCT01799356 Clinical Trial

Moxifloxacin Versus Ofloxacin Plus Metronidazole in Uncomplicated Pelvic Inflammatory Disease: Multicenter Randomized Controlled Trials

Pelvic Inflammatory Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01799356
Other study ID # Asicioglu03
Secondary ID treatmenttreatme
Status Completed
Phase Phase 4
First received February 16, 2013
Last updated August 27, 2013
Start date June 2010
Est. completion date March 2013

Study information
Verified date August 2013
Source Istanbul Bakirkoy Maternity and Children Diseases Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationTurkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 1303
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 45 Years
Eligibility Inclusion Criteria:

1. Women diagnosed uncomplicated PID

2. Patients age are between 14 with 45

3. Pelvic tenderness and vaginal discharge

Exclusion Criteria:

1. Urinary Tract Enfections

2. Tubo-ovarian abscess and complicated PID

3. History of antibiotics treatment

4. Other pelvic pain causes

5. Endometriosis

6. Delivery,abortion and surgery within last months

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Moxifloxacin
daily 400 mg moksifloksasin
• Ofloxacin
daily 800 mg oflaksasin plus 1000 mg metronidazol treatment
• Metronidazole
daily 1000 mg metronidazol plus 800 mg oflaksasin treatment for uPID

Locations
Country Name City State
Turkey T.C.S.B. Kanuni Sultan Suleyman Training Hospital Istanbul Kucukcekmece
Turkey T.C.S.B Mardin Women and Children Hospital Mardin
Turkey T.C.S.B. Istanbul Training Research Hospital Samatya Fatih
Turkey T.C.S.B. Sisli Etfal Training Research Hospital Sisli

Sponsors (1)
Lead Sponsor Collaborator
Istanbul Bakirkoy Maternity and Children Diseases Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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: 10.125 — View Citation

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 Clinically cure 21 Days Yes
Secondary Microbiological cure 21 Days Yes
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