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Reduction of Spontaneous Prematurity by Antibiotic Treatment (Josamycin)

NCT00718705 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3200

Last updated 2011-12-29

No results posted yet for this study

Summary

The purpose of this study is to test the effectiveness of an antibiotic treatment (Josamycin) in the case of positive PCR for Ureaplasma spp. and/or Mycoplasma hominis in the second quarter on the risk of premature birth.

Conditions

  • Prematurity

Interventions

DRUG

Josamycin

josamycin with posology of 2 grams per day by oral way during 10 days

DRUG

Placebo

Placebo with posology of 2 grams per day by oral way during 10 days

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Gilles KAYEM · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • France

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00718705 on ClinicalTrials.gov