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Reduction of Spontaneous Prematurity by Antibiotic Treatment (Josamycin) (PREMYC)

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00718705
First received: July 17, 2008
Last updated: December 27, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Prematurity
 Drug: Josamycin
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Reduction of Spontaneous Prematurity: Impact of Antibiotic Treatment (Josamycin) in Case of Positive PCR for Ureaplasma Spp and/or Mycoplasma Hominis in Amniotic Fluid

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Premature birth [ Time Frame: between 22 and 37 completed weeks of pregnancy. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Antenatal :occurence of a miscarriage late [ Time Frame: between 16 and 22 weeks of amenorrhoea ] [ Designated as safety issue: Yes ]
  • Antenatal : premature delivery [ Time Frame: at week of amenorrhea <= 34, 32, 28 ] [ Designated as safety issue: Yes ]
  • Antenatal : hospitalisation for risk of premature delivery [ Time Frame: antenatal period ] [ Designated as safety issue: Yes ]
  • antenatal : Number of day of hospitalisation for risk of premature delivery [ Time Frame: antenatal period ] [ Designated as safety issue: Yes ]
  • Antenatal : premature rupture of membranes [ Time Frame: before 37 week of amenorrhea ] [ Designated as safety issue: Yes ]
  • Antenatal : occurence of chorioamnionitis defined by 2 of the following criteria :maternal temperature > 38°C, uterine contractions, Fetid leucorrhoeas, foetal tachycardia > 160bpm, C reactive protein >10mg/l [ Time Frame: antenatal period ] [ Designated as safety issue: Yes ]
  • During childbirth : Hyperthermia > 38°C [ Time Frame: Childbirth period ] [ Designated as safety issue: Yes ]
  • During childbirth : fetal tachycardia > 160 bpm [ Time Frame: childbirth period ] [ Designated as safety issue: Yes ]
  • Post-partum : Hyperthermia > 38°C for more than 24hours [ Time Frame: post partum period ] [ Designated as safety issue: Yes ]
  • Post partum :need an antibiotic treatment for more than 48 hours [ Time Frame: post partum period ] [ Designated as safety issue: Yes ]
  • Neonatal : neonatal mortality late [ Time Frame: from day 7 to day 28 ] [ Designated as safety issue: Yes ]
  • Neonatal : early neonatal mortality [ Time Frame: from day 0 to day 6 ] [ Designated as safety issue: Yes ]
  • Neonatal morbidity : immediate neonatal state [ Time Frame: neonatal period ] [ Designated as safety issue: Yes ]
  • Neonatal morbidity : infection [ Time Frame: neonatal period ] [ Designated as safety issue: Yes ]
  • Neonatal morbidity : respiratory disease [ Time Frame: neonatal period ] [ Designated as safety issue: Yes ]
  • Neonatal morbidity : digestive disease [ Time Frame: neonatal period ] [ Designated as safety issue: Yes ]

Enrollment: 3200
Study Start Date: July 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
josamycin
 Drug: Josamycin
josamycin with posology of 2 grams per day by oral way during 10 days
Other Name: Josamycin
Placebo Comparator: 2
Placebo
 Drug: Placebo
Placebo with posology of 2 grams per day by oral way during 10 days
Other Name: Placebo

Detailed Description:

Infection would be the cause of 40 % of spontaneous premature deliveries. The physiopathological hypothesis accepted is a premature ascent of present bacteria in the low genital ways towards the decidual, the foetal membranes then the amniotic liquid. These bacteria are responsible for an inflammatory reaction to the interface feto-maternal characterized by the production of proinflammatory cytokines and pro-contractants agents (prostaglandins, oxytocin) by the decidual and the membranes.

These mediators cause uterine contractions, a maturation of the uterine collar, a rupture of the membranes then a premature birth.

Several recent publications show on the one hand that Mycoplasma hominis and Ureaplasma spp. are the bacteria most frequently found in the amniotic liquid in the second quarter of the pregnancy and that a positive PCR for these bacteria is associated with a premature birth.

A probable assumption would be that Mycoplasma hominis or Ureaplasma spp. cause a premature birth by infecting the fetal membranes and the decidual, then activating the immune system and the pro-inflammatory production of cytokines. These bacteria are sensitive to antibiotic treatment.

Nevertheless, no randomized controlled trials have been carried out to determine wether an antibiotic treatment would decrease spontaneous prematurity in the case of positive PCR in the amniotic liquid.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient older ≥ 18 years
  • French speaking
  • Women who have an amniocentesis between 15 and 20 weeks of amenorrhoea for an antenatal diagnosis
  • Affiliated to social security or an equivalent system
  • Karyotype analysis and ultrasound morphological normal (apart from minor signs of trisomy 21)
  • Clear amniotic fluid (not contaminated by the mother's blood)
  • Gestational age is between 15 WA(day+0) and 20 WA(day+6)
  • Patient have not allergy to macrolides
  • Do not have cure underway by macrolide
  • Patient followed during her pregnancy in an investigator site
  • Informed consent and signed

Exclusion Criteria:

  • No speaking french
  • Having an allergy to macrolides
  • Having a multiple pregnancy
  • Morphological Anomaly
  • Patient no consented
  • Lactose Intolerance
  • Not agreed to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718705

Locations
France
Groupe Hospitalier Chenevier-Mondor, CHI
Creteil, France, 94
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Bayer
Investigators
Principal Investigator: Gilles KAYEM Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00718705     History of Changes
Other Study ID Numbers: P060216
Study First Received: July 17, 2008
Last Updated: December 27, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Prematurity
Ureaplasma spp
Mycoplasma Hominis
Amniotic fluid
Josamycine

Additional relevant MeSH terms:
Anti-Bacterial Agents
Josamycin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013