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

Sponsor
Istanbul Bakirkoy Maternity and Children Diseases Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01799356
Collaborator
(none)
1,303
Enrollment
4
Locations
2
Arms
33
Duration (Months)
325.8
Patients Per Site
9.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
1303 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: moxifloxacin Group

Treatment at uPID with moxifloxacin

Drug: Moxifloxacin
daily 400 mg moksifloksasin
Other Names:
  • new generetaion flouroquinolon antibiotics

    		•
    Placebo Comparator: Ofloxacin Group

    Treatment at uPID with Ofloxacin plus metronidazole

    Drug: Ofloxacin
    daily 800 mg oflaksasin plus 1000 mg metronidazol treatment
    Other Names:
  • floroquinolon antibiotics

    • Drug: Metronidazole
    daily 1000 mg metronidazol plus 800 mg oflaksasin treatment for uPID
    Other Names:
  • anaerobic antibiotics

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinically cure [21 Days]

    Secondary Outcome Measures

    1. Microbiological cure [21 Days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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. Hıstory of antibiotics treatment

    4. Other pelvic pain causes

    5. Endometriosis

    6. Delivery,abortion and surgery within last months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 T.C.S.B. İstanbul Training Research Hospital Samatya Fatih Turkey 34180
    2 T.C.S.B. Kanuni Sultan Suleyman Training Hospital İstanbul Kucukcekmece Turkey 34280
    3 T.C.S.B Mardin Women and Children Hospital Mardin Turkey 47000
    4 T.C.S.B. Şişli Etfal Training Research Hospital Şişli Turkey 34150

    Sponsors and Collaborators

    • Istanbul Bakirkoy Maternity and Children Diseases Hospital

    Investigators

    • Study Chair: Kemal Gungorduk, md, T.C.S.B. Kanıni Sultan Suleyman Training Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Osman Aşıcıoğlu, Istanbul Sisli Etfal Training Research Hospital, Istanbul Bakirkoy Maternity and Children Diseases Hospital
    ClinicalTrials.gov Identifier:
    NCT01799356
    Other Study ID Numbers:
    • Asicioglu03
    • treatment
    • treatment uPID
    First Posted:
    Feb 26, 2013
    Last Update Posted:
    Aug 28, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by Osman Aşıcıoğlu, Istanbul Sisli Etfal Training Research Hospital, Istanbul Bakirkoy Maternity and Children Diseases Hospital
    Treatment, moksifloksasin
    Additional relevant MeSH terms:
    Pelvic Inflammatory Disease
    Pelvic Infection
    Anti-Bacterial Agents
    Moxifloxacin
    Metronidazole
    Ofloxacin
    Antibiotics, Antitubercular

    Study Results

    No Results Posted as of Aug 28, 2013