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

Phase 4

Completed

• Conditions: Pelvic Inflammatory Disease
• Interventions: Drug: Ofloxacin group A, Azitromycin group B; Drug: azitromycin

• Registration Number: NCT01241110
• Lead Sponsor: Guilan University of Medical Sciences

Brief Summary

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

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

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Status Verified: 2010-10
• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-15
• Last Update Submitted: 2010-11-15
• Study First Posted: 2010-11-16
• Last Update Posted: 2010-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
azitromicin,PID treatment,ofluxacin	Ofloxacin group A, Azitromycin group B	-
azitromicin,PID treatment,ofluxacin	azitromycin	-

Primary Outcome Measures

Name	Time	Method
to compare two oral antibiotic protocols in terms of side effects and efficacy.	Jan 2010- Aug 2010	side effects- and efficacy

Secondary Outcome Measures

Name	Time	Method
single oral dose of Azitromicine could be the drug of choice in the outpatient treatment of Pelvic Inflammatory Disease	Jan 2010- Aug 2010	compliance and cost

Trial Locations

Locations (1)

Alzahra Maternity Hospital; 🇮🇷 Rasht, Guilan, Iran, Islamic Republic of