Last reviewed · How we verify

NCT01719510: Col-Strepto B

Interest of the Detection of Hyper-virulent Clone ST17 of Group B Strep (GBS) for the Prevention of Neonatal GBS Meningitis

Completed NA Last updated 5 September 2025
What this trial tests

NA trial testing Samples in Neonatal Infections Colonize With Group B Streptococci in 949 participants. Completed in 3 June 2015.

Timeline
12 November 2012
Primary endpoint
3 June 2015
3 June 2015

Quick facts

Lead sponsorAssistance Publique - Hôpitaux de Paris
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposescreening
Enrollment949
Start date12 November 2012
Primary completion3 June 2015
Estimated completion3 June 2015
Sites2 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, female only, with Neonatal Infections Colonize With Group B Streptococci. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main objective of this study : Demonstrate that GBS (group B streptococci) "ST-17" colonize and persist to 60 days twice in the digestive tract of newborns that strains of GBS non-ST-17. Secondary objectives:Determine: * The frequency of colonization with GBS ST-17 and GBS non-ST-17 of at risk pregnant women. * The frequency of colonization of neonates by GBS ST-17 at birth. * The preferential site of colonization in the mother (rectum, vagina, breast milk). * The kinetics of colonization after birth in the newborn. * The sensitivity and specificity of different GBS detection methods (conventional phenotypic versus molecular) in the different types of samples from the mother and the newborn.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Samples

Trials testing the same drug.

Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT01719510.

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