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
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary efficacy endpoint is survival of patients treated with suramin compared to the natural history cohort.