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

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ClinicalTrials.gov Identifier: NCT01241110

Recruitment Status : Completed

First Posted : November 16, 2010

Last Update Posted : November 16, 2010

Sponsor:

Information provided by:

Guilan University of Medical Sciences

Study Description

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

Condition or disease	Intervention/treatment	Phase
Pelvic Inflammatory Disease	Drug: Ofloxacin group A, Azitromycin group B Drug: azitromycin	Phase 4

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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase 4 Study of Azitromicin in the Treatment of PID
Study Start Date :	January 2010
Actual Primary Completion Date :	August 2010
Actual Study Completion Date :	September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Inflammatory Disease

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

to compare two oral antibiotic protocols in terms of side effects and efficacy. [ Time Frame: Jan 2010- Aug 2010 ]
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 ]
compliance and cost

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


Responsible Party:	fariba mirblook, GUMS
ClinicalTrials.gov Identifier:	NCT01241110 History of Changes
Other Study ID Numbers:	ClinicalTrials.gov R01DA013131 ( U.S. NIH Grant/Contract )
First Posted:	November 16, 2010 Key Record Dates
Last Update Posted:	November 16, 2010
Last Verified:	October 2010

Keywords provided by Guilan University of Medical Sciences:


PID, Ofloxacin, Azitromicine, Metronidazole

Additional relevant MeSH terms:


Pelvic Inflammatory Disease Pelvic Infection Adnexal Diseases Genital Diseases, Female Infection Metronidazole Ofloxacin Levofloxacin Anti-Infective Agents Antiprotozoal Agents Antiparasitic Agents	Anti-Infective Agents, Urinary Renal Agents Anti-Bacterial Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors

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