Clinical trial NCT05645822: Screen and Treat Implementation for HAT Control
Official title: Screen and Treat Implementation in Insecure Areas With Limited Capacities for HAT Control
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sleeping Sickness
Trypanosomiasis, African
Keywords: Sleeping sickness
Human African Trypanosomiasis
Fexinidazole
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Ministry of Public Health, Democratic Republic of the Congo
name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
name: SANRU Asbl, Soins de Santé Primaires en Milieu Rural, République Démocratique du Congo
name: Drugs for Neglected Diseases
First posted: 2022-12-12
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 9 health facilities in the endemic health zones of Kasongo, Kikombo, Kunda and Samba in the province of Maniema, Kongolo in the province of Tanganyika and Lubao in the province of Lomami are selected based on reported HAT cases 3 years prior, where fexinidazole treatment has been provided through PNLTHA or DNDi and where sample transport will be ensured by the NGO SANRU, despite difficult accessibility.

The study aims to include every person that attends the participating fixed healthcare facilitie with suggestive symptoms of gHAT (see above) and is willing to provide informed consent. Since the feasibility of this approach is being tested, as many participants as possible will be included from the pool of people that attend participating healthcare centers during the study period.

Brief 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.

Detailed description: In this study, all gHAT suspects that attend participating health facilities with suggestive symptoms and test positive in an antibody detection rapid test, will presumptively be treated with fexinidazole. Blood samples will be collected for the post-hoc confirmation of the infection. Nine Health facilities have been selected in the health zones of Kasongo, Kibombo, Kunda and Samba (province of Maniema), Kongolo (province of Tanganyika) and Lubao (province of Lomami) by the PNLTHA, and ITM, based on both epidemiological data and operational considerations.

All patients that consult the selected facilities showing any symptom that could be attributed to gHAT will be offered to participate in the study and kindly requested to provide informed consent. Participants will be tested using the rapid diagnostic test (RDT) HAT Sero-K-SeT. All positive individuals will be asked to provide a venous blood sample, that will be sent to the Institut National de Recherche Biomédical (INRB) or Centre de Recherche en Santé de Kimpese (CRSK) for further serological testing with iELISA and/or immune trypanolysis (TL) and to confirm diagnosis with molecular testing. They will also be offered a 10-day fexinidazole treatment, as inpatient. After treatment, the study participants will be asked to return to the health facility after six months for a clinical follow-up.

Two follow -up visits (3 and 6 months) will be actively organized for all patients with a positive result in iELISA and/or molecular tests conducted at INRB/Kimpese laboratory, through active tracing by health facilities and community members. At the 3 month visit, a clinical examination and DNA/RNA sampling for molecular testing will be performed. At the 6 month visit, adverse events and disease status will be assessed based on clinical signs or symptoms. After the 6-month visit, all patients with a confirmed gHAT infection will be invited to come back to health facility 12, 18 and 24 months after treatment, following WHO guidelines, to confirm cure.

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.

Primary outcomes:
measure: Assess the feasibility of an alternative operational approach for the diagnosis and treatment of gHAT patients in areas with limited access and diagnostic capacities.
timeFrame: 11 months
Secondary outcomes:
measure: Assess gHAT transmission in the provinces of Maniema, Tanganyka and partially Lomami.
timeFrame: 11 months
measure: Contribute to the collection of evidence of the use of fexinidazole.
timeFrame: 11 months.
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Tropical Medicine
name: Raquel Inocencio da Luz, PhD
role: PRINCIPAL_INVESTIGATOR
References: