Status:
COMPLETED
Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP2 Passive Case Detection
Lead Sponsor:
Institut de Recherche pour le Developpement
Collaborating Sponsors:
Ministry of Public Health, Democratic Republic of the Congo
Ministry of Health, Guinea
Conditions:
African Trypanosomiases
West African; Trypanosomiasis
Eligibility:
All Genders
4+ years
Phase:
NA
Brief Summary
The study determines the diagnostic performance and cost of rapid diagnostic tests (RDTs) performed on human African trypanosomiasis clinical suspects in peripheral health centres, whether or not foll...
Detailed Description
In the last decade, the prevalence of Trypanosoma brucei gambiense human African trypanosomiasis (HAT) has fallen and HAT has been targeted for elimination. At low disease prevalence, integration of c...
Eligibility Criteria
Inclusion
- Visit of or residence in a HAT endemic area
- Clinical suspicion of HAT based on: Recurrent fever not responding to anti-malarial medication; or Headache for a long duration (\>14 days); or presence of swollen lymph nodes in the neck; or Important weight loss; or Weakness; or Important scratching; or Amenorrhea, abortion(s), or sterility; or Coma; or Psychiatric problems (aggressiveness, apathy, mental confusion, increasing unusual hilarity, ...); or Sleep disruption (nocturnal insomnia and excessive diurnal sleeping); or Motor abnormalities (convulsions, abnormal movements, shaking, walking difficulties); or Speech disorders.
Exclusion
- Previously treated for HAT (irrespective of time elapsed since treatment)
- No informed consent
- \< 4 years old
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
10700 Patients enrolled
Trial Details
Trial ID
NCT03356665
Start Date
August 1 2017
End Date
January 31 2021
Last Update
February 21 2021
Active Locations (3)
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1
Institut Pierre Richet, Institut National de Santé Publique
Bouaké, Côte d’Ivoire
2
Programme Nationale de Lutte contre la trypanosomiase humaine Africaine
Kinshasa, Democratic Republic of the Congo
3
Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine, Ministère de Santé, Division Prévention et Lutte contre la Maladie
Conakry, Guinea