Trypanosoma Brucei Rhodesiense; Infection Clinical Trial
Official title:
A Retrospective Analysis of Suramin Treatment for Stage 1 Trypanosoma Brucei Rhodesiense Human African Trypanosomiasis (S1 TBR HAT) in Uganda and Malawi
NCT number | NCT06060600 |
Other study ID # | PAX-HAT-301 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2, 2023 |
Est. completion date | August 2, 2023 |
Verified date | September 2023 |
Source | Paxmedica |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 345 |
Est. completion date | August 2, 2023 |
Est. primary completion date | August 2, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | 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 acceptable. Exclusion Criteria: Patient records that meet any of the following criteria will be excluded from the suramin-treated cohort: - Reported duration of symptoms for more than 2 months at time of presentation at a healthcare facility. - Stage 2 TBR HAT as determined by examination of cerebrospinal fluid (CSF) using WHO criteria, which classify patients with the presence of trypanosomes in the CSF and/or a WBC count >5 cells/mm3 as Stage 2 TBR HAT at time of presentation to a healthcare facility. - Evidence of Stage 2 TBR HAT symptoms at time of presentation to a healthcare facility. - Required medication treatment for Stage 2 illness (melarsoprol) prior to time of presentation to a healthcare facility. - Known to have had Trypanosoma Brucei Gambiense (TBG) HAT or became ill while travelling from an area known to be endemic for TBG HAT - Duration of HAT symptoms for more than 6 months. Survival for more than 6 months with TBR HAT is unlikely. |
Country | Name | City | State |
---|---|---|---|
United States | PaxMedica | Tarrytown | New York |
Lead Sponsor | Collaborator |
---|---|
Paxmedica |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
30 Days | |
Secondary | The secondary objective is to describe the safety and tolerability of suramin. | • Incidence of adverse events. | 30 Days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03974178 -
Efficacy and Safety of Fexinidazole in Patients With Human African Trypanosomiasis (HAT) Due to Trypanosoma Brucei Rhodesiense
|
Phase 2/Phase 3 |