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Completed

NCT Number: NCT01241110

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

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

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Key information

Conditions

Pelvic Inflammatory Disease Adnexal Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Pelvic Infection Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Alzahra Maternity Hospital

Rasht, Gilan Province, 16746, Iran

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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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.

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Treatment and study plan

Ofloxacin group A, Azitromycin group B

Drug

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 names: azitromicin, ofluxacin

azitromycin

Drug

azitromicin vs ofluxacin

Other names: azitromicin, ofluxacin

Primary outcomes

  1. to compare two oral antibiotic protocols in terms of side effects and efficacy.

    Time frame: Jan 2010- Aug 2010

    side effects- and efficacy

Secondary outcomes

  1. 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

    compliance and cost

Sponsors and collaborators

Lead sponsor

Guilan University of Medical Sciences

Other

Registry information

Official study title

Phase 4 Study of Azitromicin in the Treatment of PID

Acronym: CTO

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 16, 2010
Registry last updated
Nov 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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