Trial · NCT07227779

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 16 of 16

List	Outcome	Time frame	Description
Primary	24-week Survival	24 Weeks	Survival Time
Primary	Hierarchical composite endpoint (survival time + functional status)	24 Weeks	Hierarchical composite endpoint of survival time and Rankin score (0-5 scale) assessed by Win Ratio
Secondary	Serious adverse events (SAE)	28 weeks	Incidience of Serious adverse events
Secondary	Clinical Adverse Events	28 weeks	Clinical Adverse Events, by grade (1-5) associated with TB drug discontinuation, dose reduction, or interruption \>=3 days
Secondary	Laboratory abnormalities	28 weeks	Number of participants with grade 3 or 4 abnormal laboratory values, by the Division of AIDS toxicity grading scale
Secondary	Neuropathy	28 weeks	Incidence of Neuropathy
Secondary	Drug induced liver injury	28 weeks	Drug induced liver injury with Grade \>=3 with serum alanine aminotransferase (ALT) \>5x upper limit or normal or total bilirubin \>2.5x upper limit of normal)
Secondary	Change in CSF inflammatory markers	14 days	Change in CSF leukocytes from baseline to day 7 and 14 visits.
Secondary	Modified Rankin Scale	24 weeks	Modified Rankin Score as an ordinal score (0-6 scale) of: 0 Alive: no residual symptoms or disability. 1. No significant disability: symptoms are present but do not prevent carrying out all usual duties and activities; able to carry out all pre-TBM activities. 2. Slight disability: unable to carry out all pre-TBM activities but able to look after self without daily help. 3. Moderate disability: requires some assistance with tasks but able to walk without assistance. 4. Moderately severe disability: unable attend to bodily functions or walk without assistance. 5. Severe disabilities: bedridden, incontinent, requires continuous care and attention. 6. Dead
Secondary	Change in blood inflammatory markers	7 days	Change in white blood cell count from baseline to day 7 visit
Secondary	Quantitative neurocognitive performance Z-score	24 weeks	Quantitative neurocognitive performance Z-score scaled to Ugandan population adult norms where population average = 0. Performance is Z-scored such that performance that is one standard deviation better than average is +1 and one standard deviation worse is -1.
Secondary	Change in PCR cycle threshold (Ct) value in CSF	14 days	Change in PCR cycle threshold (Ct) value in CSF from baseline to Day 7 and 14 visits.
Secondary	Altered Mental Status over time	10 days	Number of days with Glasgow Coma Scale score = 15 within the first 10 days
Secondary	Additional corticosteroids use	24 weeks	Additional corticosteroids use in TBM survivors (beyond initial use)
Secondary	Change in CSF glcuose	14 days	Change in CSF glucose from baseline to day 7 to day 14
Secondary	Change in serum C-reactive protein	7 days	Change in serum C-reactive protein (CRP) from baseline to day 7

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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