A Phase 2 interventional study of thiamine hydrochloride 100 mg and Placebo in Meningitis and Bacteremia, sponsored by Milton S. Hershey Medical Center. Not yet recruiting at 2 sites in United States. Open to participants aged Up to 12 Months. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Milton S. Hershey Medical Center · Phase 2, Interventional, and Treatment
To determine if the addition of thiamine to standard-of-care treatment will improve neurodevelopmental outcomes for infants with meningitis or bacteremia
381 studies on the registry are indexed under Meningitis; 33 are open to participants now.
This study's planned enrollment of 240 is above the median of 215 across 262 interventional studies indexed under Meningitis.
Browse Meningitis studies →Milton S. Hershey Medical Center is the lead sponsor of 491 studies on the registry; 59 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 44 (76%) have results posted.
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Exclusion Criteria:
Participant will receive IV thiamine in addition to standard of care treatment
Drug: thiamine hydrochloride 100 mg
Participant will receive placebo (IV saline solution) in addition to standard-of-care treatment.
Other: Placebo
Patients will receive 100mg of IV thiamine in addition to standard-of-care treatment, once a day for three days
Participants will receive placebo in addition to standard-of-care treatment
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.
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.
Plan to share: Yes — De-identified IPD will be made available following study completion
Supporting information: Study protocol, Clinical study report, Analytic code
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Thiamine hydrochloride
Milton S. Hershey Medical Center →