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

July 17, 2008
December 27, 2011
July 2008
September 2011   (final data collection date for primary outcome measure)
Premature birth [ Time Frame: between 22 and 37 completed weeks of pregnancy. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00718705 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Reduction of Spontaneous Prematurity by Antibiotic Treatment (Josamycin)
Reduction of Spontaneous Prematurity: Impact of Antibiotic Treatment (Josamycin) in Case of Positive PCR for Ureaplasma Spp and/or Mycoplasma Hominis in Amniotic Fluid

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Prematurity
  • Drug: Josamycin
    josamycin with posology of 2 grams per day by oral way during 10 days
    Other Name: Josamycin
  • Drug: Placebo
    Placebo with posology of 2 grams per day by oral way during 10 days
    Other Name: Placebo
  • Experimental: 1
    josamycin
    Intervention: Drug: Josamycin
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3200
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00718705
P060216
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Bayer
Principal Investigator: Gilles KAYEM Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP