A Retrospective Analysis of Suramin Treatment for Stage 1 TBR
NCT ID: NCT06060600
Last Updated: 2023-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
345 participants
OBSERVATIONAL
2023-01-02
2023-08-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study's objectives are to evaluate the efficacy and safety of suramin in the Stage 1 treatment of TBR HAT.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
ECOLOGIC_OR_COMMUNITY
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
Retrospective cohort
The hospital records of TBR HAT patients will be examined for date of symptom onset (if available) and hospital admission, race, sex, age, geographic area of origin, parasites, concomitant medications and illnesses, co-infections, and disease stage. Patients are normally screened for HAT and other tropical diseases using standard parasitological World Health Organization (WHO) criteria. Briefly, blood is obtained from the patients and checked for the presence of trypanosomes using direct wet smear and capillary centrifugation technique methods. Disease stage determination is by examination of CSF using the 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. Stage 2 patients would be disqualified from inclusion in the study.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Paxmedica
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
jennifer L bonfrisco
Role: STUDY_DIRECTOR
Paxmedica
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
PaxMedica
Tarrytown, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PAX-HAT-301
Identifier Type: -
Identifier Source: org_study_id