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

Study Overview
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Brief Summary
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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
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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

Official Title
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Phase 4 Study of Azitromicin in the Treatment of PID

Conditions
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Pelvic Inflammatory Disease

Intervention / Treatment
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* Drug: Ofloxacin group A, Azitromycin group B
* Drug: azitromycin


Participation Criteria
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Eligibility Criteria
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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. -
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: azitromicin,PID treatment,ofluxacin<br> | Drug: Ofloxacin group A, Azitromycin group B<br>* 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.<br>* Other names: azitromicin, ofluxacin;Drug: azitromycin<br>* azitromicin vs ofluxacin<br>* Other names: ofluxacin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare two oral antibiotic protocols in terms of side effects and efficacy. | side effects- and efficacy | Jan 2010- Aug 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PID, Ofloxacin, Azitromicine, Metronidazole