Text Size

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

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
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

No publications provided

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
Infection
Adnexal Diseases
Genital Diseases, Female
Metronidazole
Ofloxacin
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on May 16, 2013