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

Sponsor
Guilan University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01241110
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
8
Duration (Months)
12.5
Patients Per Site Per Month

Study Details

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
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
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 :
Jan 1, 2010
Actual Primary Completion Date :
Aug 1, 2010
Actual Study Completion Date :
Sep 1, 2010

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 Names:
  • azitromicin, ofluxacin

    • Drug: azitromycin
    azitromicin vs ofluxacin
    Other Names:
  • azitromicin
  • ofluxacin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. to compare two oral antibiotic protocols in terms of side effects and efficacy. [Jan 2010- Aug 2010]

      side effects- and efficacy

    Secondary Outcome Measures

    1. single oral dose of Azitromicine could be the drug of choice in the outpatient treatment of Pelvic Inflammatory Disease [Jan 2010- Aug 2010]

      compliance and cost

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01241110
    Other Study ID Numbers:
    • ClinicalTrials.gov
    • R01DA013131
    First Posted:
    Nov 16, 2010
    Last Update Posted:
    Nov 16, 2010
    Last Verified:
    Oct 1, 2010
    Keywords provided by , ,
    PID, Ofloxacin, Azitromicine, Metronidazole
    Additional relevant MeSH terms:
    Pelvic Inflammatory Disease
    Pelvic Infection
    Ofloxacin

    Study Results

    No Results Posted as of Nov 16, 2010