THiamine for Recovery In Vulnerable Early-life Infections

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT07868679
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Bacteremia
  • Meningitis

Eligibility Criteria

Sex
ALL
Age
N/A - 12 Months
Healthy Volunteers
Not accepted

Interventions

  • thiamine hydrochloride 100 mg — DRUG
    Patients will receive 100mg of IV thiamine in addition to standard-of-care treatment, once a day for three days
  • Placebo — OTHER
    Participants will receive placebo in addition to standard-of-care treatment

Study Details

To determine if the addition of thiamine to standard-of-care treatment will improve neurodevelopmental outcomes for infants with meningitis or bacteremia

Key Dates

First listed
Oct 9, 2026
Start date
Dec 1, 2026
Status verified
Oct 2026
Primary completion
Nov 30, 2031
Completion
Nov 30, 2031

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Thiamine
    Participant will receive IV thiamine in addition to standard of care treatment
  • Placebo Comparator: Placebo
    Participant will receive placebo (IV saline solution) in addition to standard-of-care treatment.

Primary Outcome Measure

Cognitive Neurodevelopment [ Time Frame: The end-of-study visit will be conducted at 18 months of age for all participants. This will mean that some participants will be assessed nearly 18 months after their infection and others will be assessed ~6 months from their infection. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Sarah U. Morton, MD, PhD
[email protected]
617-355-6000
Sarah U. Morton, MD, PhD (PRINCIPAL_INVESTIGATOR)
Penn State Health Milton S. Hershey Medical CenterHersheyPennsylvania17033
Brennen Harding, MS
[email protected]
717-531-5656
Jessica Ericson, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Boston Children's Hospital· Boston, MAPenn State Health Milton S. Hershey Medical Center· Hershey, PA

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