NCT06356974: STROgHAT

Stop Transmission of Gambiense Human African Trypanosomiasis (STROgHAT)

Not yet recruiting Phase 3 Last updated 10 April 2024

What this trial tests

Phase 3 trial testing Treatment of seropositive individuals (positive serology test, but parasitology not confirmed) in Human African Trypanosomiasis in 2,500 participants. Not yet recruiting.

Timeline

8 April 2024

Primary endpoint
30 December 2026

30 December 2027

Quick facts

Lead sponsor	Drugs for Neglected Diseases
Phase	Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2,500
Start date	8 April 2024
Primary completion	30 December 2026
Estimated completion	30 December 2027

Drugs / interventions tested

• Treatment of seropositive individuals (positive serology test, but parasitology not confirmed) — full drug profile →

Conditions studied

• Human African Trypanosomiasis — all drugs for Human African Trypanosomiasis →

Sponsor

Drugs for Neglected Diseases — full company profile →

Who can join

11 and older, any sex, with Human African Trypanosomiasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

The investigators 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, that it 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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The STROGHAT study protocol: An intervention study to evaluate safety, effectiveness and feasibility of treating gambiense HAT seropositive subjects with acoziborole.
   Nicco E, Lejon V, Mwamba Miaka E, Mumba D, et al · · 2025 · cited 6× · PMID 40191624 · DOI 10.12688/openreseurope.19077.1
2. Passive surveillance of human African trypanosomiasis in the Democratic Republic of the Congo: clinical presentation and prospective evaluation of rapid diagnostic and reference laboratory test accuracy.
   Makabuza J, Lukusa IN, Lumbala C, Miaka EM, et al · · 2025 · cited 1× · PMID 41021650 · DOI 10.1371/journal.pntd.0013045
3. The STROGHAT study protocol: An intervention study to evaluate safety, effectiveness and feasibility of treating gambiense HAT seropositive subjects with acoziborole.
   Nicco E, Lejon V, Mwamba Miaka E, Mumba D, et al · · 2025 · DOI 10.12688/openreseurope.19077.1