The study will include TBR HAT patients treated with suramin between 2000 and 2020 at three sites in Uganda and Malawi A natural history cohort composed of source data from approximately 200 patients from a published epidemiological study will be used as a comparator. This study's objectives are to evaluate the efficacy and safety of suramin in the Stage 1 treatment of TBR HAT.
The study will include TBR HAT patients treated with suramin between 2000 and 2020 at three sites in Uganda and Malawi (e.g., the retrospective suramin-treated cohort). The study will include all the approximately 145 patients who are deemed eligible through chart review and who have sufficient data. A natural history cohort composed of source data from approximately 200 patients from a published epidemiological study will be used as a comparator. The primary objective is to determine whether standard of care treatment with suramin, as currently practiced in Uganda and Malawi, leads to better health outcomes in patients with S1 TBR HAT than observed in a natural history cohort with source data from a published epidemiologic study.
Study Type
OBSERVATIONAL
Enrollment
345
PaxMedica
Tarrytown, New York, United States
The primary efficacy endpoint is survival of patients treated with suramin compared to the natural history cohort.
The primary efficacy analysis will compare the proportion alive and not meeting any of the following criteria * Death (both cohorts). * Progression from Stage 1 to Stage 2 TBR HAT as defined by meeting any of the following: * presence of TBR trypanosomes in the cerebrospinal fluid (CSF) * abnormal symptoms . * presence of TBR HAT symptoms for more than 2 months * Use of melarsoprol for clinical worsening or treatment failure * Moribund status
Time frame: 30 Days
The secondary objective is to describe the safety and tolerability of suramin.
• Incidence of adverse events.
Time frame: 30 Days
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