A Retrospective Analysis of Suramin Treatment for Stage 1 TBR (NCT06060600) | Clinical Trial Compass
CompletedNot Applicable
A Retrospective Analysis of Suramin Treatment for Stage 1 TBR
United States345 participantsStarted 2023-01-02
Plain-language summary
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.
Who can participate
SexALL
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Inclusion Criteria:
* Suramin-treated cohort:
* Patient records must meet all the following criteria to be included in the suramin-treated cohort:
* Male or female of any age; age or sex must be included.
* Treatment with at least four full doses of suramin (not including the test dose).
* Onset date or duration of symptoms associated with S1 TBR HAT is available.
* An outcome is required; any mention of a clinical outcome is acceptable.
* Must live in an area endemic for TBR HAT
* Documented HAT diagnosis
* Positive parasitology for HAT (observed in blood sample or a standard test).
Natural History cohort:
* Treatment records from a cohort of approximately 200 patients who were hospitalized between 1901 and 1910 during the 1900-1920 HAT epidemic
* Treatment records must have sufficient information for analysis including:
* Demographic data: age or sex must be included
* Diagnosis: HAT diagnosis is confirmed by blood or lymph gland fluid analysis and parasites observed or HAT symptoms during the epidemic. For example, if the records state that a lymph node biopsy was performed, any result of the biopsy (e.g., documentation that trypanosomes were observed), a documentation of the HAT diagnosis, or mention of HAT symptoms such as sleepiness or excess sleeping are all acceptable. Symptoms alone are not sufficient, but a notation of biopsy and mention of HAT symptoms is acceptable.
* Outcome: An outcome is required; any mention of a clinical outcome is …
What they're measuring
1
The primary efficacy endpoint is survival of patients treated with suramin compared to the natural history cohort.