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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
NA trial testing Samples in Neonatal Infections Colonize With Group B Streptococci in 949 participants. Completed in 3 June 2015.
3 June 2015
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 949 |
| Start date | 12 November 2012 |
| Primary completion | 3 June 2015 |
| Estimated completion | 3 June 2015 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Samples — full drug profile →
Conditions studied
- Neonatal Infections Colonize With Group B Streptococci — all drugs for Neonatal Infections Colonize With Group B Streptococci →
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:
- PubMed search for NCT01719510
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01719510 (US National Library of Medicine, public domain)
- 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: 5 September 2025
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