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

Primary Purpose

Pelvic Inflammatory Disease

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ofloxacin group A, Azitromycin group B
azitromycin
Sponsored by
Guilan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Inflammatory Disease focused on measuring PID, Ofloxacin, Azitromicine, Metronidazole

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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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Sites / Locations

  • Alzahra Maternity Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

azitromicin,PID treatment,ofluxacin

Arm Description

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
November 15, 2010
Last Updated
November 15, 2010
Sponsor
Guilan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01241110
Brief Title
To Compare Ofloxacin With Azitromycin for Pelvic Inflammatory Disease (PID) Treatment
Acronym
CTO
Official Title
Phase 4 Study of Azitromicin in the Treatment of PID
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Guilan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Inflammatory Disease
Keywords
PID, Ofloxacin, Azitromicine, Metronidazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
azitromicin,PID treatment,ofluxacin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ofloxacin group A, Azitromycin group B
Other Intervention Name(s)
azitromicin, ofluxacin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
azitromycin
Other Intervention Name(s)
azitromicin, ofluxacin
Intervention Description
azitromicin vs ofluxacin
Primary Outcome Measure Information:
Title
to compare two oral antibiotic protocols in terms of side effects and efficacy.
Description
side effects- and efficacy
Time Frame
Jan 2010- Aug 2010
Secondary Outcome Measure Information:
Title
single oral dose of Azitromicine could be the drug of choice in the outpatient treatment of Pelvic Inflammatory Disease
Description
compliance and cost
Time Frame
Jan 2010- Aug 2010

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fariba Mirblook, MD
Organizational Affiliation
Guilan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alzahra Maternity Hospital
City
Rasht
State/Province
Guilan
ZIP/Postal Code
16746
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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