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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01799356
First Posted: February 26, 2013
Last Update Posted: August 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
  Purpose
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 Intervention Phase
Pelvic Inflammatory Disease Drug: Moxifloxacin Drug: Ofloxacin Drug: Metronidazole Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital:

Primary Outcome Measures:
  • Clinically cure [ Time Frame: 21 Days ]

Secondary Outcome Measures:
  • Microbiological cure [ Time Frame: 21 Days ]

Enrollment: 1303
Study Start Date: June 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: moxifloxacin Group
Treatment at uPID with moxifloxacin
Drug: Moxifloxacin
daily 400 mg moksifloksasin
Other Name: 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 Name: floroquinolon antibiotics
Drug: Metronidazole
daily 1000 mg metronidazol plus 800 mg oflaksasin treatment for uPID
Other Name: anaerobic antibiotics

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799356


Locations
Turkey
T.C.S.B. İstanbul Training Research Hospital
Samatya, Fatih, Turkey, 34180
T.C.S.B. Kanuni Sultan Suleyman Training Hospital
İstanbul, Kucukcekmece, Turkey, 34280
T.C.S.B Mardin Women and Children Hospital
Mardin, Turkey, 47000
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
  More Information

Publications:
Responsible Party: Osman Aşıcıoğlu, Istanbul Sisli Etfal Training Research Hospital, Istanbul Bakirkoy Maternity and Children Diseases Hospital
ClinicalTrials.gov Identifier: NCT01799356     History of Changes
Other Study ID Numbers: Asicioglu03
treatment ( Other Identifier: treatment pelvic inflammatuary disease )
treatment uPID ( Other Identifier: we aimed this study treatment uPID )
First Submitted: February 16, 2013
First Posted: February 26, 2013
Last Update Posted: August 28, 2013
Last Verified: August 2013

Keywords provided by Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital:
Treatment, moksifloksasin

Additional relevant MeSH terms:
Pelvic Inflammatory Disease
Pelvic Infection
Adnexal Diseases
Genital Diseases, Female
Contraceptive Agents, Female
Infection
Anti-Bacterial Agents
Moxifloxacin
Fluoroquinolones
Ofloxacin
Levofloxacin
Antibiotics, Antitubercular
Metronidazole
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Urinary