To Compare Ofloxacin With Azitromycin for Pelvic Inflammatory Disease (PID) Treatment - Full Text View

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 Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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


Genders 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.

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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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Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided


Responsible Party:	fariba mirblook, GUMS
ClinicalTrials.gov Identifier:	NCT01241110 History of Changes
Other Study ID Numbers:	ClinicalTrials.gov, R01DA013131
Study First Received:	November 15, 2010
Last Updated:	November 15, 2010
Health Authority:	Iran: Ministry of Health

Keywords provided by Guilan University of Medical Sciences:


PID, Ofloxacin, Azitromicine, Metronidazole

Additional relevant MeSH terms:


Pelvic Infection Pelvic Inflammatory Disease Adnexal Diseases Genital Diseases, Female Infection Levofloxacin Ofloxacin Anti-Bacterial Agents Anti-Infective Agents	Anti-Infective Agents, Urinary Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Renal Agents Therapeutic Uses Topoisomerase II Inhibitors Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on February 25, 2015

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