Stop Transmission of Gambiense Human African Trypanosomiasis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age11+
SponsorInstitute of Tropical Medicine, Belgium
About this trial
This protocol describes both the epidemiological study which aims at assessing whether over a three-year period a zero prevalence can be achieved when implementing a screen \& treat approach with acoziborole, as well as a nested clinical study aimed at generating further evidence on safety of acoziborole in gambiense human African trypanosomiasis (gHAT) seropositives individuals. The overall coordinator will be ITM. ITM will be fully responsible for the epidemiological study (study Part A), including cost effectiveness and evaluation of diagnostic tests. DNDi will be the legal sponsor of the nested safety clinical study (study Part B) and will ensure compliance with regulatory requirements and good clinical practices (GCP) for this part of the study.
We hypothesize that by systematically screening the populations of all endemic villages in a well-defined HAT focus and by expanding gHAT treatment to all seropositives, we will be able to arrive at a zero prevalence over a three-year period.
The objectives are to evaluate whether a strategy based on widened treatment for all parasitologically negative seropositive gHAT suspects with acoziborole can lead to interruption of transmission of T.b.gambiense in a mainland focus and to assess the safety of acoziborole in gHAT seropositve individuals and parasitologically negative.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants able to give signed informed consent and assent form for adolescents, which includes willingness to comply with the schedule of follow-up visits and other requirements and restrictions listed in the informed consent form (ICF) and in this protocol
All sexes
11 years of age or older at the start of the study and weight ≥30 kg at the screening of Part B
Participants who are CATT test or HAT RDT positive (information provided by the mobile team and included into TrypElim (see Part A)
Disqualifiers
Individuals with a positive parasitological exam on the spot at baseline (mAECT or lymph gland puncture)
Participants previously treated for g-HAT or previously treated because of gHAT seropositive results
Pregnant women
Breast-feeding women
Trial design
Design model
Single group
Treatments tested in this trial
Acoziborole
Drugtreatment of seropositive individuals (positive serology test, but parasitology not confirmed). Subjects agreeing to participate study and matching the inclusion/exclusion criteria will receive acoziborole 960 or 640 mg in a single intake at study day 1. Following treatment, participants will attend follow-up visits at home or at the study centre at 3 days and 3-months post-treatment.
Treatment groups
2,500 Participants
are divided into 1 treatment groupGroup A: treatment of seropositivesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
interruption of transmission of T.b. gambiense
\- To evaluate whether a strategy based on widened treatment for all parasitologically negative seropositive gHAT suspects with acoziborole can lead to interruption of transmission of T.b. gambiense in a mainland focus. The number of parasitologically negative seropositive gHAT suspects is reduced to zero or near zero within the timeframe of the project
Time frame
4 years2
Assessment of Safety
To assess the safety of acoziborole in gHAT seropositive individuals and parasitologically-negative by measuring the proportion of participants who present related treatment emergent severe adverse events. Mild, moderate and severe related ermergent adverse events will be measured.
Time frame
3 yearOther outcomes
1
economic evaluation
Cost data will be gathered throughout the study and used to perform an economic evaluation of the screen \& treat strategy. Recurrent and capital costs of the screen \& treat strategy will be considered.
Time frame
4 years2
assessment of the performance of several diagnostic tests
\- Prospective assessment of specificity and positive predictive value of the screening tests used in the field, CATT and RDT, and of the referral laboratory tests, ELISA/T.b. gambiense, immune trypanolysis and Trypanozoon-RT-PCR multiplex. If a functional inhibition ELISA and a T.b. gambiense specific qPCR become available during STROGHAT, their specificity will be determined retrospectively on the collected study specimens. For the specificity evaluation parasitology will be used as reference test. The specificity will be calculated by measuring the number of index tests negatives over the number of index test negatives plus intex test positives testing negative with the reference test. The reference standard will be parasitological confirmation.
Time frame
4 yearsSponsors and contacts
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Institute of Tropical Medicine, Belgium
Lead sponsor
Drugs for Neglected Diseases
Collaborator
Institut de Recherche pour le Developpement
Collaborator
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Collaborator
Ministry of Public Health, Democratic Republic of the Congo
Collaborator
Source ClinicalTrials.gov