NCT00718705 (PREMYC) is a Phase 3 clinical trial of Josamycin in Prematurity, sponsored by Assistance Publique - Hôpitaux de Paris.

Who is sponsoring NCT00718705?

NCT00718705 is sponsored by Assistance Publique - Hôpitaux de Paris.

What drugs are being tested in NCT00718705?

Interventions in NCT00718705: Josamycin, Placebo.

What condition does NCT00718705 study?

NCT00718705 studies Prematurity.

Is NCT00718705 still recruiting?

NCT00718705 is currently completed. Last updated 27 December 2011.

Last reviewed 2011-12-27 · How we verify

NCT00718705: PREMYC

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Reduction of Spontaneous Prematurity: Impact of Antibiotic Treatment (Josamycin) in Case of Positive PCR for Ureaplasma Spp and/or Mycoplasma Hominis in Amniotic Fluid

Completed Phase 3 Last updated 27 December 2011

What this trial tests

Phase 3 trial testing Josamycin in Prematurity in 3,200 participants. Completed in 1 September 2011.

Timeline

1 July 2008

Primary endpoint
1 September 2011

1 September 2011

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	3,200
Start date	1 July 2008
Primary completion	1 September 2011
Estimated completion	1 September 2011
Sites	1 location across France

Drugs / interventions tested

Josamycin (JOSAMYCIN) — full drug profile →
Placebo

Conditions studied

Prematurity — all drugs for Prematurity →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, female only, with Prematurity. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Premature birth
Time frame: between 22 and 37 completed weeks of pregnancy.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Antibiotics for amniotic-fluid colonization by Ureaplasma and/or Mycoplasma spp. to prevent preterm birth: A randomized trial.
Kayem G, Doloy A, Schmitz T, Chitrit Y, et al · · 2018 · cited 17× · PMID 30403730 · DOI 10.1371/journal.pone.0206290
Second-trimester amniotic fluid proteins changes in subsequent spontaneous preterm birth.
Marcellin L, Batteux F, Chouzenoux S, Schmitz T, et al · · 2023 · cited 2× · PMID 36918342 · DOI 10.1111/aogs.14544

Verify or expand the search:

Other recruiting trials for Prematurity

Currently open trials in the same condition.

NCT06965530 — Nourishing Tomorrow: Role of Medically Tailored Groceries in Addressing Food Insecurity During Pregnancy · NA · recruiting
NCT06420531 — Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial · NA · recruiting
NCT07183462 — Azithromycin and Ampicillin for Late PPROM · Phase 4 · recruiting
NCT06536296 — The Impact of Music Medicine on Preterm Brain Development and Behavior · NA · recruiting
NCT07213414 — Metagenomic & Metabolomic Study: Bifidobacterium Probiotic Effects on Gut Microbiota & SCFA in Preterm NICU Infants · EARLY_PHASE1 · active not recruiting

Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

NCT07443436 — Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants · Phase 2 · not yet recruiting
NCT07499492 — Red Blood Cell Transfusion to Optimize Extubation · NA · not yet recruiting
NCT07379918 — Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer · recruiting
NCT07473869 — Smartphone Application for Automated Measurement of Capillary Refill Time (CRT) · not yet recruiting
NCT07505394 — Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00718705 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
Last refreshed: 27 December 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00718705.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing