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PrematurityPhase 3PREMYCNCT00718705

Reduction of Spontaneous Prematurity by Antibiotic Treatment (Josamycin)

A Phase 3 study testing Josamycin in people with Prematurity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Prematurity
What is being tested?
Josamycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,200 participants
Where
1 siteFrance
Study dates
Jul 2008to Sep 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 11Show fewer
  • 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

Who cannot join

  • No speaking french
  • Having an allergy to macrolides
  • Having a multiple pregnancy
  • Morphological Anomaly
  • Patient no consented
  • Lactose Intolerance
  • Not agreed to participate

Trial locations and contacts

1 site in 1 country.

France1 site

  • Groupe Hospitalier Chenevier-Mondor, CHI

    Créteil, 94

Other trials in France

About this study

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

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.

Read the 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.

Conditions
Prematurity
Being tested
Josamycin, Placebo
Keywords
Prematurity, Ureaplasma spp, Mycoplasma Hominis, Amniotic fluid, Josamycine
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JosamycinDrug

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

  • PlaceboDrug

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

Study groups in NCT00718705
Study groupRoleWhat they receive
1Experimentaljosamycin
Receives: Drug: Josamycin
2Placebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Premature birth

    Measured: between 22 and 37 completed weeks of pregnancy.

Secondary outcomes (16)

  1. Antenatal :occurence of a miscarriage late

    Measured: between 16 and 22 weeks of amenorrhoea

  2. Antenatal : premature delivery

    Measured: at week of amenorrhea <= 34, 32, 28

  3. Antenatal : hospitalisation for risk of premature delivery

    Measured: antenatal period

  4. antenatal : Number of day of hospitalisation for risk of premature delivery

    Measured: antenatal period

  5. Antenatal : premature rupture of membranes

    Measured: before 37 week of amenorrhea

  6. 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

    Measured: antenatal period

  7. During childbirth : Hyperthermia > 38°C

    Measured: Childbirth period

  8. During childbirth : fetal tachycardia > 160 bpm

    Measured: childbirth period

  9. Post-partum : Hyperthermia > 38°C for more than 24hours

    Measured: post partum period

  10. Post partum :need an antibiotic treatment for more than 48 hours

    Measured: post partum period

  11. Neonatal : neonatal mortality late

    Measured: from day 7 to day 28

  12. Neonatal : early neonatal mortality

    Measured: from day 0 to day 6

  13. Neonatal morbidity : immediate neonatal state

    Measured: neonatal period

  14. Neonatal morbidity : infection

    Measured: neonatal period

  15. Neonatal morbidity : respiratory disease

    Measured: neonatal period

  16. Neonatal morbidity : digestive disease

    Measured: neonatal period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionSep 2011
  4. Study completionSep 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00718705
Sponsor's protocol ID
P060216
Acronym
PREMYC
Status last verified
May 2011
First submitted
17 Jul 2008
Last updated
29 Dec 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Marcellin L, Batteux F, Chouzenoux S, Schmitz T, Lorthe E, Mehats C, Goffinet F, Kayem G. Second-trimester amniotic fluid proteins changes in subsequent spontaneous preterm birth. Acta Obstet Gynecol Scand. 2023 May;102(5):597-604. doi: 10.1111/aogs.14544. Epub 2023 Mar 14.

    PubMed 36918342

  • Kayem G, Doloy A, Schmitz T, Chitrit Y, Bouhanna P, Carbonne B, Jouannic JM, Mandelbrot L, Benachi A, Azria E, Maillard F, Fenollar F, Poyart C, Bebear C, Goffinet F. Antibiotics for amniotic-fluid colonization by Ureaplasma and/or Mycoplasma spp. to prevent preterm birth: A randomized trial. PLoS One. 2018 Nov 7;13(11):e0206290. doi: 10.1371/journal.pone.0206290. eCollection 2018.

    PubMed 30403730

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Josamycin in people with Prematurity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Premature birth (time frame: between 22 and 37 completed weeks of pregnancy.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00718705, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2011.

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