Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06356974
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-29
Brief Title:
Stop Transmission of Gambiense Human African Trypanosomiasis STROgHAT
Sponsor:
Drugs for Neglected Diseases
Organization:
Drugs for Neglected Diseases
Study Overview
Official Title:
An Intervention Study to Evaluate the Impact of Treating gHAT Seropositive Subjects With Acoziborole on Transmission of Tb Gambiense and Obtain Further Safety Data on Acoziborole in gHAT Seropositive Individuals
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STROgHAT
Brief Summary:
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 Tbgambiense in a mainland focus and to assess the safety of acoziborole in gHAT seropositve individuals and parasitologically negative
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 Tbgambiense in a mainland focus and to assess the safety of acoziborole in gHAT seropositve individuals and parasitologically negative
Detailed Description:
Recently acoziborole a non-toxic single dose oral drug for gHAT has passed phase 3 evaluation in adult patients This drug is envisioned to be used to treat gHAT irrespective of disease stage thus rendering the lumbar puncture for stage determination redundant Having available a single dose oral treatment with limited risk of toxicity opens up new perspectives for eliminating the disease Treating anyone testing positive to a serological screening test without further need for on the spot parasitological confirmation and stage determination will greatly simplify procedures in the field avoid missing many cases has the potential to increase uptake of screening and may thus even curb transmission of the causative parasite which is assumed to have only a human reservoir
Although this innovative option for gHAT control is now feasible its true effectiveness and cost effectiveness for curtailing transmission remain to be determined
The current gHAT control strategy is based on active screening of people living in villages at risk for gHAT by mobile screening teams All villages from which gHAT cases were reported are screened for three years in a row until no further cases are found They are then screened once more two years after the last case was reported If no further cases are found transmission is assumed to have been interrupted However it has also previously been shown estimated that up to 50 of prevalent cases are not detected or not cured with major losses occurring during the parasitological confirmation step Other important barriers are the fear of the lumbar puncture required for stage determination and of toxicity of treatment in particular associated with melarsoprol no longer in use for gHAT but still well-known especially by the elder population Even if up to 50 of prevalent gHAT cases were not treated the epidemiological data shows that the disease is on the decline This may however be insufficient to achieve complete elimination of transmission 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 Bearing in mind that acoziborole has not yet been registered and that screen treat has not yet been adopted as the new policy the investigators will for the duration of this study continue performing parasitological confirmation on the spot and treat anyone confirmed by parasitology with standard of care Any serological suspect not confirmed by parasitology on the spot will be offered treatment with acoziborole study Part B conditional on a set of inclusion and exclusion criteria If acoziborole allows the investigators to implement a screen treat strategy allowing to detect and treat all g-HAT prevalent cases and possibly in the future without the limitations of cumbersome diagnostic confirmation on the spot the investigators expect that elimination of transmission is also possible in a mainland focus Implementing such a study under relatively well controlled conditions will also allow gathering further evidence on safety of acoziborole before a screen treat strategy is rolled out on a larger scale In addition it will provide information on the cost of such a strategy and on some essential parameters of the tests utilized
Although this innovative option for gHAT control is now feasible its true effectiveness and cost effectiveness for curtailing transmission remain to be determined
The current gHAT control strategy is based on active screening of people living in villages at risk for gHAT by mobile screening teams All villages from which gHAT cases were reported are screened for three years in a row until no further cases are found They are then screened once more two years after the last case was reported If no further cases are found transmission is assumed to have been interrupted However it has also previously been shown estimated that up to 50 of prevalent cases are not detected or not cured with major losses occurring during the parasitological confirmation step Other important barriers are the fear of the lumbar puncture required for stage determination and of toxicity of treatment in particular associated with melarsoprol no longer in use for gHAT but still well-known especially by the elder population Even if up to 50 of prevalent gHAT cases were not treated the epidemiological data shows that the disease is on the decline This may however be insufficient to achieve complete elimination of transmission 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 Bearing in mind that acoziborole has not yet been registered and that screen treat has not yet been adopted as the new policy the investigators will for the duration of this study continue performing parasitological confirmation on the spot and treat anyone confirmed by parasitology with standard of care Any serological suspect not confirmed by parasitology on the spot will be offered treatment with acoziborole study Part B conditional on a set of inclusion and exclusion criteria If acoziborole allows the investigators to implement a screen treat strategy allowing to detect and treat all g-HAT prevalent cases and possibly in the future without the limitations of cumbersome diagnostic confirmation on the spot the investigators expect that elimination of transmission is also possible in a mainland focus Implementing such a study under relatively well controlled conditions will also allow gathering further evidence on safety of acoziborole before a screen treat strategy is rolled out on a larger scale In addition it will provide information on the cost of such a strategy and on some essential parameters of the tests utilized
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None