THiamine for Recovery In Vulnerable Early-life Infections

NCT07868679 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY00030064R01HD122957
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Meningitis; Bacteremia

Keywords

thiamine; meningitis; bacteremia

Outcome Measures

Primary Outcomes (1)

• Cognitive Neurodevelopment

  The primary outcome will be cognitive neurodevelopment as measured by the Bayley Scales of Infant Development at 18 months of age. We will compare the mean cognitive score for infants who received thiamine vs. placebo in addition to standard-of-care treatment.

  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.

Study Arms (2)

Thiamine

EXPERIMENTAL

Participant will receive IV thiamine in addition to standard of care treatment

Drug: thiamine hydrochloride 100 mg

Placebo

PLACEBO COMPARATOR

Participant will receive placebo (IV saline solution) in addition to standard-of-care treatment.

Other: Placebo

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

Thiamine

Placebo OTHER

Participants will receive placebo in addition to standard-of-care treatment

Placebo

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ≤12 months old
• Clinical concern for bacteremia or meningitis (fever or hypothermia and lethargy; fever or hypothermia and poor feeding; fever or hypothermia and seizure, bulging fontanelle or nuchal rigidity)
• Legal guardian has provided informed consent
• No known neurologic or developmental comorbidity (e.g. trisomy 21, congenital structural brain abnormality)
• Weight ≥ 2kg

You may not qualify if:

• Known neurologic or developmental comorbidity including genetic disorders
• Weight \< 2 kg
• Prior episode of bacteremia or meningitis
• Already receiving thiamine as standard-of-care

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (2)

• 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.

  PMID: 38321529 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.

  PMID: 41632684 BACKGROUND

MeSH Terms

Conditions

Meningitis; Bacteremia

Interventions

thiamine hydrochloride

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jessica Ericson, MD

CONTACT

717 531 0003; jericson@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pediatrics and Infectious Diseases

Model Details: Thiamine vs. placebo in addition to standard-of-care treatment

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): November 30, 2031
• Study Completion (Estimated): November 30, 2031
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE

Locations

US (2)