Trypanosoma Brucei Gambiense; Infection Clinical Trial
— DiTECT-WP2Official title:
Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP2 Passive Case Detection
Verified date | February 2021 |
Source | Institut de Recherche pour le Developpement |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 followed by serological and/or molecular tests on dried blood spots done at regional reference centres
Status | Completed |
Enrollment | 10700 |
Est. completion date | January 31, 2021 |
Est. primary completion date | January 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - Previously treated for HAT (irrespective of time elapsed since treatment) - No informed consent - < 4 years old |
Country | Name | City | State |
---|---|---|---|
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 | |
Guinea | Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine, Ministère de Santé, Division Prévention et Lutte contre la Maladie | Conakry |
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 Health, Guinea, Ministry of Public Health, Democratic Republic of the Congo, University of Liverpool |
Congo, The Democratic Republic of the, Côte D'Ivoire, Guinea,
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* Note: There are 12 references in all — Click here to view all references
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 HAT clinical suspects | Index tests: 4 RDTs on fresh blood, and for RDT positives also immune trypanolysis on DBS, ELISA on DBS, LAMP on DBS, RT-PCR on DBS.
Reference standard: for RDT positives only: combined results of parasitological examination at inclusion and if one of tests on DBS positive, at 3 and 6 months. Subjects negative in all RDTs 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 HAT clinical suspects | Index tests: 4 RDTs on fresh blood, and for RDT positives also immune trypanolysis on DBS, ELISA on DBS, LAMP on DBS, RT-PCR on DBS.
Reference standard: for RDT positives only: combined results of parasitological examination at inclusion and if one of tests on DBS positive, at 3 and 6 months. Subjects negative in all RDTs are considered HAT negative. |
6 months |
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