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To Compare Ofloxacin With Azitromycin for Pelvic Inflammatory Disease (PID) Treatment (CTO)

This study has been completed.
Sponsor:
Information provided by:
Guilan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01241110
First received: November 15, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

Objective: To compare two oral treatments: Ofloxacin + Metronidazole, and Azitromycin +Metronidazole in outpatients with Pelvic Inflammatory Disease.

Materials and Methods: Two hundred patients divided to two groups( A , B). Group A (treated by Ofloxacin 400 mg. + Metronidazole 500mg) and Group B (a single dose of oral Azitromicine 1gr + Metronidazole 500mg) for 10 days, were compared in terms of side effects and efficacy


Condition Intervention Phase
Pelvic Inflammatory Disease
 Drug: Ofloxacin group A, Azitromycin group B
Drug: azitromycin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4 Study of Azitromicin in the Treatment of PID

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Guilan University of Medical Sciences:

Primary Outcome Measures:
  • to compare two oral antibiotic protocols in terms of side effects and efficacy. [ Time Frame: Jan 2010- Aug 2010 ] [ Designated as safety issue: Yes ]
    side effects- and efficacy


Secondary Outcome Measures:
  • single oral dose of Azitromicine could be the drug of choice in the outpatient treatment of Pelvic Inflammatory Disease [ Time Frame: Jan 2010- Aug 2010 ] [ Designated as safety issue: Yes ]
    compliance and cost
Enrollment: 100
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: azitromicin,PID treatment,ofluxacin Drug: Ofloxacin group A, Azitromycin group B
Group A (treated by Ofloxacin 400 mg. + Metronidazole 500mg) and Group B (a single dose of oral Azitromicine 1gr + Metronidazole 500mg) for 10 days, were compared in terms of side effects and efficacy.
Other Name: azitromicin, ofluxacin
Drug: azitromycin
azitromicin vs ofluxacin
Other Names:
  • azitromicin
  • ofluxacin

Detailed Description:
Two hundred patients divided to two groups( A , B). Group A (treated by Ofloxacin 400 mg. + Metronidazole 500mg) and Group B (a single dose of oral Azitromicine 1gr + Metronidazole 500mg) for 10 days, were compared in terms of side effects and efficacy
  Eligibility
Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Eligibility criteria were having three out of five following symptoms: a-lower abdominal pain, b-vaginal discharges, c- adnexal tenderness, d-cervical motion tenderness (CMT), e-cervisitis.

Exclusion Criteria:Excluding criteria were as follows: a-unmarried women, b-pregnant women, c-women with infection during menstruation, d- history of abortion or miscarriage during the last month, e-underlying diseases such as diabetes, f-used antibiotics in the last month, or allergy to the antibiotics used in the study, g-history of Pelvic Inflammatory Disease within the last year, and h- suspicion of being multi partner.

  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: NCT01241110

Locations
Iran, Islamic Republic of
Alzahra Maternity Hospital
Rasht, Guilan, Iran, Islamic Republic of, 16746
Sponsors and Collaborators
Guilan University of Medical Sciences
Investigators
Principal Investigator: Fariba Mirblook, MD Guilan University of Medical Sciences
  More Information

Responsible Party: fariba mirblook, GUMS
ClinicalTrials.gov Identifier: NCT01241110     History of Changes
Other Study ID Numbers: ClinicalTrials.gov  R01DA013131 
Study First Received: November 15, 2010
Last Updated: November 15, 2010
Health Authority: Iran: Ministry of Health

Keywords provided by Guilan University of Medical Sciences:
PID, Ofloxacin, Azitromicine, Metronidazole

Additional relevant MeSH terms:
Pelvic Inflammatory Disease
Pelvic Infection
Adnexal Diseases
Genital Diseases, Female
Infection
Metronidazole
Ofloxacin
Levofloxacin
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
 Anti-Infective Agents, Urinary
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 26, 2016