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The problem
Intervention: Clofazimine treatment with weight-based dosing: 100 mg once daily (≥20 kg), every second day (10 to <20 kg), or thrice weekly (<10 kg)
Who it was tested with: 54 South African children aged <18 years (median 3.3 years, range 0.5-15.6 years) with rifampicin-resistant tuberculosis, including 5 living with HIV.
The same group is measured before the intervention and again afterwards, with a baseline and an endline and sometimes a midline. Change is visible, but other causes cannot be ruled out.
"An observational cohort study of South African children <18 years old routinely treated for RR-TB with a clofazimine-containing regimen was analyzed... PK sampling and electrocardiograms were completed pre-dose and at 1, 4, and 10 hours post-dose." This describes a pre-post measurement design without a comparison group, characterising drug exposure and cardiac safety in treated children.
Observational design without control group; small sample size, particularly for HIV-positive subgroup (n=5); single-centre study in South Africa; limited ability to determine optimal dosing strategies
Across countries and designs
1 study · 2 countries
