We updated the design of this site on September 25th. Learn more.

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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01241110

First Posted: November 16, 2010

Last Update Posted: November 16, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Guilan University of Medical Sciences

Purpose

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	Intervention	Phase
Pelvic Inflammatory Disease	Drug: Ofloxacin group A, Azitromycin group B Drug: azitromycin	Phase 4


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Inflammatory Disease

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Guilan University of Medical Sciences:

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


Enrollment:	100
Study Start Date:	January 2010
Study Completion Date:	September 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	Child, Adult, Senior
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 Submitted:	November 15, 2010
First Posted:	November 16, 2010
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

To Top