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

This study has been completed.
Information provided by (Responsible Party):
Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital Identifier:
First received: February 16, 2013
Last updated: August 27, 2013
Last verified: August 2013
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Clinically cure [ Time Frame: 21 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Microbiological cure [ Time Frame: 21 Days ] [ Designated as safety issue: Yes ]

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


Ages Eligible for Study:   14 Years to 45 Years
Genders 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
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Please refer to this study by its identifier: NCT01799356

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

Responsible Party: Osman Aşıcıoğlu, Istanbul Sisli Etfal Training Research Hospital, Istanbul Bakirkoy Maternity and Children Diseases Hospital Identifier: NCT01799356     History of Changes
Other Study ID Numbers: Asicioglu03  treatment  treatment uPID 
Study First Received: February 16, 2013
Last Updated: August 27, 2013
Health Authority: United States: Food and Drug Administration
Turkey: Ethics Committee

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

Additional relevant MeSH terms:
Pelvic Infection
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Contraceptive Agents, Female
Anti-Bacterial Agents
Antibiotics, Antitubercular
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antineoplastic Agents
Antiparasitic Agents
Antiprotozoal Agents
Antitubercular Agents
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Renal Agents
Reproductive Control Agents
Topoisomerase II Inhibitors processed this record on May 22, 2016