MeningitisPhase 2THRIVENCT07868679
THiamine for Recovery In Vulnerable Early-life Infections
A Phase 2 study testing thiamine hydrochloride 100 mg in people with Meningitis and Bacteremia, run by Milton S. Hershey Medical Center at 2 sites in United States.
Trial summary
To determine if the addition of thiamine to standard-of-care treatment will improve neurodevelopmental outcomes for infants with meningitis or bacteremia Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Meningitis, Bacteremia
- What is being tested?
- thiamine hydrochloride 100 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2026to 30 Nov 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≤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
Who cannot join
- Known neurologic or developmental comorbidity including genetic disorders
- Weight < 2 kg
- Prior episode of bacteremia or meningitis
- Already receiving thiamine as standard-of-care
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Sarah U. Morton, MD, PhD, 617-355-6000, Sarah.Morton@childrens.harvard.edu
Sarah U. Morton, MD, PhD
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Brennen Harding, MS, 717-531-5656, bharding@pennstatehealth.psu.edu
Jessica Ericson, MD
About this study
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
- Being tested
- thiamine hydrochloride 100 mg, Placebo
- Keywords
- thiamine, meningitis, bacteremia
- Medical subject headings
- Meningitis, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thiamine hydrochloride 100 mgDrug
Patients will receive 100mg of IV thiamine in addition to standard-of-care treatment, once a day for three days
PlaceboOther
Participants will receive placebo in addition to standard-of-care treatment
| Study group | Role | What they receive |
|---|---|---|
| Thiamine | Experimental | Participant will receive IV thiamine in addition to standard of care treatment Receives: Drug: thiamine hydrochloride 100 mg |
| Placebo | Placebo comparator | Participant will receive placebo (IV saline solution) in addition to standard-of-care treatment. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Nov 2031 (estimated)
- Study completion30 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MeningitisStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Thiamine vs. placebo in addition to standard-of-care treatment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jessica Ericson, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868679
- Sponsor's protocol ID
- STUDY00030064
- Other IDs
- R01HD122957
- Acronym
- THRIVE
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD will be made available following study completion
Publications
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.
PubMed 38321529Smith 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.
PubMed 41632684
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THiamine for Recovery In Vulnerable Early-life Infections
- ClinicalTrials.gov ID
- NCT07868679
- Acronym / sponsor ID
- THRIVE / STUDY00030064
- Conditions
- Meningitis, Bacteremia
- Keywords
- thiamine, meningitis, bacteremia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Nov 2031 (estimated)
- Study completion
- 30 Nov 2031 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if the addition of thiamine to standard-of-care treatment will improve neurodevelopmental outcomes for infants with meningitis or bacteremia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Thiamine vs. placebo in addition to standard-of-care treatment
| Arm | Type | Receives |
|---|---|---|
| Thiamine | Experimental | Drug: thiamine hydrochloride 100 mgParticipant will receive IV thiamine in addition to standard of care treatment |
| Placebo | Placebo comparator | Other: PlaceboParticipant will receive placebo (IV saline solution) in addition to standard-of-care treatment. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- ≤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
Key exclusion criteria (4 listed)
- Known neurologic or developmental comorbidity including genetic disorders
- Weight < 2 kg
- Prior episode of bacteremia or meningitis
- Already receiving thiamine as standard-of-care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thiamine hydrochloride 100 mgPatients will receive 100mg of IV thiamine in addition to standard-of-care treatment, once a day for three days | Drug | Thiamine |
| PlaceboParticipants will receive placebo in addition to standard-of-care treatment | Other | Placebo |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 38321529Vine 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: PubMed 41632684Smith 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.
- Individual participant dataSharing planned: Yes. De-identified IPD will be made available following study completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing thiamine hydrochloride 100 mg in people with Meningitis and Bacteremia, run by Milton S. Hershey Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Ericson, MD (717 531 0003 ext. 282277, jericson@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07868679, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.