Optimizing Treatment to Improve TBM Outcomes in Children
Summary:
This study, known as TBM Kids, is being conducted in India and Malawi.
Primary Objectives
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To characterize the pharmacokinetics (PK) (plasma and cerebrospinal fluid (CSF)) of rifampicin given at model-derived optimal daily doses and levofloxacin in children ages 6 months to 12 years of age with TBM -
To assess the relationship between rifampicin concentrations and longitudinal functional outcomes, adjusting for factors known to affect treatment response, such as stage at presentation, leukotriene A4 hydrolase (LTA4H) genotype, levofloxacin co-administration -
To evaluate the safety of TBM treatment over eight weeks, by Arm
Secondary Objectives
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To assess functional outcomes among children treated for TBM at end of intensive phase of TB treatment (2 months) and at end of treatment (12 months), by Arm -
To describe neurocognitive outcomes among children ages 6 months to 6 years treated for TBM, longitudinally over 18 months, by Arm -
To describe TBM treatment outcomes (favorable, unfavorable) at 12 months
Tuberculosis in Children - The World Health Organization (WHO) estimates that of the nine million incident cases of tuberculosis (TB) each year, one million occur in children. These numbers likely underestimate the burden of pediatric TB because of diagnostic challenges in children and because pediatric cases are not always registered with public health authorities. For these reasons, childhood TB has been called the “hidden epidemic”.
Tuberculous Meningitis (TBM) - TBM is a devastating illness, killing and disabling more patients than any other form of tuberculosis, particularly young children under the age of 5. In endemic regions, TBM is often the leading cause of childhood bacterial meningitis. In 2012, a pediatric referral center in South Africa reported that tuberculosis was a more common cause of meningitis than Streptococcus pneumoniae, Neisseria meningitides, and Haemophilus influenzae combined. There has only ever been one trial of TBM in children done decades ago. This will be the second clinical trial ever done for TBM in children and will use innovative pharmacokinetic modeling data and approaches to optimize dosing approaches for treatment of pediatric TB
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