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NCT01241110 Clinical Trial

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

Pelvic Inflammatory Disease Clinical Trial

— CTO  

Official title:
Phase 4 Study of Azitromicin in the Treatment of PID

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01241110
Other study ID # ClinicalTrials.gov
Secondary ID R01DA013131
Status Completed
Phase Phase 4
First received November 15, 2010
Last updated November 15, 2010
Start date January 2010
Est. completion date September 2010

Study information
Verified date October 2010
Source Guilan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date September 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.
• azitromycin
azitromicin vs ofluxacin

Locations
Country Name City State
Iran, Islamic Republic of Alzahra Maternity Hospital Rasht Guilan

Sponsors (1)
Lead Sponsor Collaborator
Guilan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary to compare two oral antibiotic protocols in terms of side effects and efficacy. side effects- and efficacy Jan 2010- Aug 2010 Yes
Secondary single oral dose of Azitromicine could be the drug of choice in the outpatient treatment of Pelvic Inflammatory Disease compliance and cost Jan 2010- Aug 2010 Yes
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