NCT01241110

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
Last Updated

November 16, 2010

Status Verified

October 1, 2010

Enrollment Period

7 months

First QC Date

November 15, 2010

Last Update Submit

November 15, 2010

Conditions

Pelvic Inflammatory Disease

Keywords

PID, Ofloxacin, Azitromicine, Metronidazole

Outcome Measures

Primary Outcomes (1)

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

    side effects- and efficacy

    Jan 2010- Aug 2010

Secondary Outcomes (1)

  • single oral dose of Azitromicine could be the drug of choice in the outpatient treatment of Pelvic Inflammatory Disease

    Jan 2010- Aug 2010

Study Arms (1)

azitromicin,PID treatment,ofluxacin

ACTIVE COMPARATOR
Drug: Ofloxacin group A, Azitromycin group BDrug: azitromycin

Interventions

Ofloxacin group A, Azitromycin group BDRUG

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.

Also known as: azitromicin, ofluxacin
azitromicin,PID treatment,ofluxacin
azitromycinDRUG

azitromicin vs ofluxacin

Also known as: azitromicin, ofluxacin
azitromicin,PID treatment,ofluxacin

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alzahra Maternity Hospital

Rasht, Gilan Province, 16746, Iran

Location

MeSH Terms

Conditions

Pelvic Inflammatory Disease

Condition Hierarchy (Ancestors)

Pelvic InfectionInfectionsAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Fariba Mirblook, MD

    Guilan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 16, 2010

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

November 16, 2010

Record last verified: 2010-10

Locations

IR(1)