drugset / Trial / NCT07868679
THiamine for Recovery In Vulnerable Early-life Infections
Phase 2
Not yet recruiting
240 enrolled
Milton S. Hershey Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To determine if the addition of thiamine to standard-of-care treatment will improve neurodevelopmental outcomes for infants with meningitis or bacteremia
Timeline
- Start
- 2026-12-01
- Primary completion
- 2031-11-30
- Completion
- 2031-11-30
Publications
- Background Vine J, Lee JH, Kravitz MS, Grossestreuer AV, Balaji L, Leland SB, Berlin N, Moskowitz A, Donnino MW. Thiamine administration in septic shock: a post hoc analysis of two randomized trials. Crit Care. 2024 Feb 6;28(1):41. doi: 10.1186/s13054-024-04818-1.
- Background Smith D, Garikipati R, Bastug K, Broach JR, Schneper L, Sheldon K, Smith J, Osman M, Schiff SJ, Ericson JE. Paenibacillus dendritiformis as a Cause of Destructive Meningitis in Infants. NEJM Evid. 2026 Mar;5(3):EVIDpha2500297. doi: 10.1056/EVIDpha2500297. Epub 2026 Feb 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Thiamine | Other / unclassified | 100 mg | Intravenous |