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

  • Turkey
      • Mardin, Turkey, 47000
        • T.C.S.B Mardin Women and Children Hospital
      • Şişli, Turkey, 34150
        • T.C.S.B. Şişli Etfal Training Research Hospital
    • Fatih
      • Samatya, Fatih, Turkey, 34180
        • T.C.S.B. İstanbul Training Research Hospital
    • Kucukcekmece
      • İstanbul, Kucukcekmece, Turkey, 34280
        • T.C.S.B. Kanuni Sultan Suleyman Training Hospital

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:

  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

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
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

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.

Sponsor

Istanbul Bakirkoy Maternity and Children Diseases Hospital

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

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

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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