Thiamine for Bacterial Blood Infection

(THRIVE Trial)

Not yet recruiting at 1 trial location
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: Milton S. Hershey Medical Center
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for infants who have been diagnosed with meningitis or serious bacterial blood infections. It focuses on babies in early life who are receiving standard medical care for these conditions.

Inclusion Criteria

I am 12 months old or younger.
My legal guardian has given informed consent for my participation.
No known neurologic or developmental comorbidity such as trisomy 21 or congenital structural brain abnormality
See 2 more

Exclusion Criteria

Weight less than 2 kg
I am currently taking thiamine as part of my regular treatment.
I have a known neurologic or developmental disorder.
See 1 more

What Are the Treatments Tested in This Trial?

Interventions

  • Thiamine Hydrochloride

Trial Overview

The study is testing whether giving thiamine (vitamin B1) along with usual treatment helps improve brain development and recovery compared to a placebo. Infants are randomly assigned to receive either thiamine or a placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ThiamineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials
515
Recruited
2,873,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+