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

G

Guilan University of Medical Sciences

Status and phase

Completed
Phase 4

Conditions

Pelvic Inflammatory Disease

Treatments

Drug: Ofloxacin group A, Azitromycin group B
Drug: azitromycin

Study type

Interventional

Funder types

Other

Identifiers

NCT01241110
R01DA013131 (U.S. NIH Grant/Contract)
ClinicalTrials.gov

Details and patient eligibility

About

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

Full 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

Enrollment

100 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 1 patient group

azitromicin,PID treatment,ofluxacin
Active Comparator group
Treatment:
Drug: azitromycin
Drug: Ofloxacin group A, Azitromycin group B

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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