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

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. Identifier: NCT01799356
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : August 28, 2013
Information provided by (Responsible Party):
Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital

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
Pelvic Inflammatory Disease Drug: Moxifloxacin Drug: Ofloxacin Drug: Metronidazole Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : June 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
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

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

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

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

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

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 identifier (NCT number): NCT01799356

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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
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Study Chair: Kemal Gungorduk, md T.C.S.B. Kanıni Sultan Suleyman Training Hospital
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Osman Aşıcıoğlu, Istanbul Sisli Etfal Training Research Hospital, Istanbul Bakirkoy Maternity and Children Diseases Hospital Identifier: NCT01799356    
Other Study ID Numbers: Asicioglu03
treatment ( Other Identifier: treatment pelvic inflammatuary disease )
treatment uPID ( Other Identifier: we aimed this study treatment uPID )
First Posted: February 26, 2013    Key Record Dates
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:
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Pelvic Inflammatory Disease
Pelvic Infection
Adnexal Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Urinary
Renal Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors