Trial record 8 of 77 for:    pelvic inflammatory disease AND (woman OR women OR female)

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
ClinicalTrials.gov Identifier:
NCT01799356
First received: February 16, 2013
Last updated: August 27, 2013
Last verified: August 2013
  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
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

  Eligibility

Ages Eligible for Study:   14 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, 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 Inflammatory Disease
Pelvic Infection
Adnexal Diseases
Genital Diseases, Female
Contraceptive Agents, Female
Infection
Anti-Bacterial Agents
Ofloxacin
Antibiotics, Antitubercular
Metronidazole
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 22, 2014