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NCT05645822
Screen and Treat Implementation for HAT Control
Conditions: Sleeping Sickness, Trypanosomiasis, African
Sex: All
Ages: 6 Years – N/A
Enrollment: 300
Sponsor: Institute of Tropical Medicine, Belgium
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.
Eligibility Criteria
Inclusion Criteria:Show any suggestive symptoms of gHAT, such as headache (>14 days), long-term fever unless other obvious cause(s), malaise, weakness, arthralgia, facial edema, pruritus, lymphadenopathy, weight loss, mental confussion, abnormal behavior, logorrhea, speech impairment, anxiety, tremor, motor weakness, ataxia, abnormal gait, abnormal movements or seizures;Being older than 6 years old and weighing at least 20 kg;Willing and able to provide written informed consent (assent for minors);Minors (6 to 17 years old) willing and able to provide a written assent, after obtaining written informed consent from their parents.Exclusion Criteria:Being younger than 6 years old or weighing less than 20 kg;Refusal to provide informed consent;Previously treated for HAT (questionnaire to patients and/or family members);Pregnant women.
Source: ClinicalTrials.gov (NCT05645822). StuddyBuddy aggregates publicly available trial information.