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

This study has been completed.
Sponsor:
Information provided by:
Guilan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01241110
First received: November 15, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted

November 15, 2010
November 15, 2010
January 2010
August 2010   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
To Compare Ofloxacin With Azitromycin for Pelvic Inflammatory Disease (PID) Treatment
Phase 4 Study of Azitromicin in the Treatment of PID

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

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pelvic Inflammatory Disease
  • 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
Active Comparator: azitromicin,PID treatment,ofluxacin
Interventions:
  • Drug: Ofloxacin group A, Azitromycin group B
  • Drug: azitromycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2010
August 2010   (final data collection date for primary outcome measure)

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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Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01241110
ClinicalTrials.gov, R01DA013131
Yes
fariba mirblook, GUMS
Guilan University of Medical Sciences
Not Provided
Principal Investigator: Fariba Mirblook, MD Guilan University of Medical Sciences
Guilan University of Medical Sciences
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP