Screen and Treat Implementation for HAT Control

Trypanosomiasis, African Clinical Trial

Official title:

Screen and Treat Implementation in Insecure Areas With Limited Capacities for HAT Control

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05645822
• Other study ID #: Screen&treat
• Status: Withdrawn
• Start date: January 1, 2024
• Est. completion date: January 30, 2024

Study information

• Verified date: January 2024
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sleeping Sickness
• Trypanosomiasis
• Trypanosomiasis, African

Intervention

Other:
• Screen&treat
Study participants will be tested with an RDT to prove the presence of antibodies against Trypanosoma brucei gambiense. Should the RDT be positive, they will be offered the 10-day treatment with fexinidazole, and an additional blood sample will be taken for the post hoc confirmation of the disease.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	Drugs for Neglected Diseases, Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo, Ministry of Public Health, Democratic Republic of the Congo, SANRU Asbl, Soins de Santé Primaires en Milieu Rural, République Démocratique du Congo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the feasibility of an alternative operational approach for the diagnosis and treatment of gHAT patients in areas with limited access and diagnostic capacities.	This qualitative study will assess: Number of people with suggestive symptoms; Number of participants that test positive in the rapid diagnostic test; Number of sero-positive individuals who accept fexinidazole treatment and; Number of treated individuals who test positive in further serological/molecular tests.	11 months
Secondary	Assess gHAT transmission in the provinces of Maniema, Tanganyka and partially Lomami.	Based on the number of sero-positive individuals and confirmed infections, calculate gHAT incidence in the study areas.	11 months
Secondary	Contribute to the collection of evidence of the use of fexinidazole.	The frequency and severity of any adverse effect due to the fexinidazole treatment will be recorded by a healthcare professional during the 10-day regime as well as in the 6-month follow-up visit.	11 months.