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

Phase 4 Study of Azitromicin in the Treatment of PID

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01241110

Acronym

CTO

Enrollment

100

Registered

2010-11-16

Start date

2010-01-31

Completion date

2010-09-30

Last updated

2010-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Inflammatory Disease

Keywords

PID, Ofloxacin, Azitromicine, Metronidazole

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

Interventions

DRUGOfloxacin 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.

DRUGazitromycin

azitromicin vs ofluxacin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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. \-

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. \-

Design outcomes

Primary

Measure	Time frame	Description
to compare two oral antibiotic protocols in terms of side effects and efficacy.	Jan 2010- Aug 2010	side effects- and efficacy

Secondary

Measure	Time frame	Description
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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026