Human African Trypanosomiasis Clinical Trial
— DiTECT-HAT-WP3Official title:
Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP3 Post Elimination Monitoring
Verified date | April 2022 |
Source | Institut de Recherche pour le Developpement |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study determines the feasibility, diagnostic performance and cost for monitoring of eliminated human African trypanosomiasis (HAT) foci using diagnostic algorithms of serological and molecular high throughput tests with and without previous rapid diagnostic test blood screening for early detection of Trypanosoma brucei gambiense HAT re-emergence.
Status | Completed |
Enrollment | 13747 |
Est. completion date | January 31, 2021 |
Est. primary completion date | January 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years and older |
Eligibility | Inclusion Criteria: - Permanent resident of village (in low to zero prevalence HAT focus) for minimum 1 year Exclusion Criteria: - Previously treated for HAT (irrespective of time elapsed since treatment) - No informed consent - < 4 years old |
Country | Name | City | State |
---|---|---|---|
Burkina Faso | CIRDES | Bobo Dioulasso | |
Congo, The Democratic Republic of the | Programme Nationale de Lutte contre la trypanosomiase humaine Africaine | Kinshasa | |
Côte D'Ivoire | Institut Pierre Richet, Institut National de Santé Publique | Bouaké |
Lead Sponsor | Collaborator |
---|---|
Institut de Recherche pour le Developpement | CIRDES, Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo, Institut National de Sante Publique, Institute of Tropical Medicine, Belgium, Ministry of Public Health, Democratic Republic of the Congo, University of Liverpool |
Burkina Faso, Congo, The Democratic Republic of the, Côte D'Ivoire,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity for HAT diagnosis of RDT, RDT combinations, algorithms of RDT and serological and/or molecular tests on the population at risk | Index tests: 3 RDTs on fresh blood, immune trypanolysis on DBS, ELISA on DBS, LAMP on DBS, RT-PCR on DBS.
Reference standard: for index test positives only: combined results of 2 parasitological examinations. Subjects negative in all index tests are considered HAT negative. |
6 months | |
Primary | Specificity for HAT diagnosis of RDT, RDT combinations, algorithms of RDT and serological and/or molecular tests on the population at risk | Index tests: 3 RDTs on fresh blood, immune trypanolysis on DBS, ELISA on DBS, LAMP on DBS, RT-PCR on DBS.
Reference standard: for index test positives only: combined results of 2 parasitological examinations. Subjects negative in all index tests are considered HAT negative. |
6 months |
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