MedTrace Logo

Screen and Treat Implementation for HAT Control

NCT05645822 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2024-02-02

No results posted yet for this study

Summary

Human African Trypanosomiasis (HAT), or sleeping sickness, is one of the parasitic diseases targeted for interruption of transmission by 2030 by the WHO. The development of fexinidazole as treatment is a huge step towards this achievement; however, the diagnostic algorithm remains complex due to limited sensitivity and specificity of the available tests. A combination of serological screening and confirmation of infection through parasite visualization remains the preferred strategy, although it can be difficult to ensure its full performance in areas that are hard to reach or have limited access to electricity and other means.

The present study would like to test an approach of ensuring treatment with fexinidazole of sero-suspects without confirmation of disease, among patients that consult fixed health infrastructures in the provinces of Maniema, Lomami and Tanganyika. This should enable access to gHAT treatment for patients living in hard to reach areas, actively seeking health care.

Conditions

  • Sleeping Sickness
  • Trypanosomiasis, African

Interventions

OTHER

Screen&treat

Study participants will be tested with an RDT to prove the presence of antibodies against Trypanosoma brucei gambiense. Should the RDT be positive, they will be offered the 10-day treatment with fexinidazole, and an additional blood sample will be taken for the post hoc confirmation of the disease.

Sponsors & Collaborators

  • Ministry of Public Health, Democratic Republic of the Congo

    collaborator OTHER_GOV

  • Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

    collaborator OTHER

  • SANRU Asbl, Soins de Santé Primaires en Milieu Rural, République Démocratique du Congo

    collaborator UNKNOWN

  • Drugs for Neglected Diseases

    collaborator OTHER

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Raquel Inocencio da Luz, PhD · Institute of Tropical Medicine

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-01-30
Completion
2024-01-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05645822 on ClinicalTrials.gov