[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653728":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":32,"studyPopulation":17,"armGroups":33,"interventions":40,"overallOfficials":46,"centralContacts":51,"locations":60,"responsibleParty":82,"collaborators":86,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":17,"enrollmentInfo":106,"targetDuration":17,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":63,"whyStopped":17,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Institute of Tropical Medicine, Belgium","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":18},[9,13],{"measure":10,"description":11,"timeFrame":12},"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","4 years",{"measure":14,"description":15,"timeFrame":16},"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.","3 year",null,[19,22],{"measure":20,"description":21,"timeFrame":12},"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.",{"measure":23,"description":24,"timeFrame":12},"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\u002FT.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.\n\nThe 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.",{"allocation":26,"interventionModel":27,"interventionModelDescription":28,"primaryPurpose":29,"observationalModel":17,"timePerspective":17,"maskingInfo":30},"NA","SINGLE_GROUP","one-arm, open label, non-randomized, multicentre, phase IIIb study","TREATMENT",{"masking":31,"maskingDescription":17,"whoMasked":17},"NONE","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.\n\nAlthough this innovative option for gHAT control is now feasible, its true effectiveness and cost effectiveness for curtailing transmission remain to be determined.\n\nThe 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. This strategy has had a major impact as can be seen from figure 2 above. However, Robays et al. estimated that up to 50% of prevalent cases are not detected or not cured, with major losses occurring during the parasitological confirmation step.\\[9\\] 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. 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. Bearing in mind that acoziborole has not yet been registered and that 'screen \\& treat' has not yet been adopted as the new policy, we 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 us 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, we expect that elimination of transmission is also possible in a mainland focus. Implementing such a study under relatively well controlled conditions will also allow us to gather 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.",[34],{"label":35,"type":36,"description":37,"interventionNames":38},"treatment of seropositives","EXPERIMENTAL","The investigational product (IP) is:\n\n* acoziborole three 320-mg tablets (960 mg dose), administered by the oral route to adolescent and adults ≥15 years as single dosing regimen on Day 1 of the study in fed or fasting state\n* acoziborole two 320-mg tablets (640 mg dose), administered by the oral route to children 11-14 years (and ≥30kg) as single dosing regimen on Day 1 of the study in fed or fasting state No active comparative treatment will be used in this study\n\nDoses and treatment regimens\n\n* Adolescent and adults ≥15 years: 960 mg (3x320mg) oral unique dose in fed or fasting state\n* Children 11-14 years (and ≥30kg): 640 mg (2x320mg) oral unique dose in fed or fasting state",[39],"Drug: Acoziborole",[41],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":17},"DRUG","Acoziborole","treatment of seropositive individuals (positive serology test, but parasitology not confirmed).\n\nSubjects agreeing to participate study and matching the inclusion\u002Fexclusion 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.",[35],[47],{"name":48,"affiliation":49,"role":50},"Elena Nicco","Insitute of Tropical Medicine","STUDY_DIRECTOR",[52,56],{"name":48,"role":53,"phone":54,"phoneExt":17,"email":55},"CONTACT","+3232476497","enicco@itg.be",{"name":57,"role":53,"phone":58,"phoneExt":17,"email":59},"Digas Ngolo, MD MPH","+243813180161","dngolo@dndi.org",[61],{"facility":62,"status":63,"city":64,"state":17,"zip":17,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Coordination Provincial de Lutte contre la THA","RECRUITING","Bwamanda","Democratic Republic of the Congo","CD",{"type":68,"coordinates":69},"Point",[70,71],19.24582,3.16842,{"lat":71,"lon":70},[74,78],{"name":75,"role":53,"phone":76,"phoneExt":17,"email":77},"DR Charles Kambo, M.D.","+243817177104","charleskambo1@yahoo.fr",{"name":79,"role":53,"phone":80,"phoneExt":17,"email":81},"Jean Clement Seko","+243810897063","jeanclementseko79@gmail.com",{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Raquel Inocencio Da Luz","PhD",[87,89,92,94],{"name":88,"class":6},"Drugs for Neglected Diseases",{"name":90,"class":91},"Institut de Recherche pour le Developpement","OTHER_GOV",{"name":93,"class":6},"Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo",{"name":95,"class":91},"Ministry of Public Health, Democratic Republic of the Congo","100653728","phase-3-stop-transmission-of-gambiense-human-african-trypanosomiasis-100653728",false,"NCT07789743","Stop Transmission of Gambiense Human African Trypanosomiasis","An Intervention Study to Evaluate the Impact of Treating gHAT Seropositives Subjects With Acoziborole on Transmission of T.b. Gambiense, and Obtain Further Safety Data on Acoziborole in gHAT Seropositives Individuals.","STROgHAT","Inclusion Criteria:\n\n* 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\n* All sexes\n* 11 years of age or older at the start of the study and weight ≥30 kg at the screening of Part B\n* Participants who are CATT test or HAT RDT positive (information provided by the mobile team and included into TrypElim (see Part A)\n* Participants who are able to ingest oral tablets\n* Participants with known address and\u002For contact details provided\n* Participants who are able to comply with the schedule of follow-up visits and other requirements of the study\n* Participants must agree not take part in any other clinical trials during the participation in part B of this study\n* Participants of child-bearing potential must be willing to use appropriate contraceptive methods.\n\nExclusion Criteria:\n\n* Individuals with a positive parasitological exam on the spot at baseline (mAECT or lymph gland puncture)\n* Participants previously treated for g-HAT or previously treated because of gHAT seropositive results\n* Pregnant women\n* Breast-feeding women\n* Children ≥11 years, but under 30kg body weight at the screening for part B\n* Clinically significant medical condition that could, in the opinion of the investigator, jeopardise the subject's safety or participation in the study\n* Individuals presenting a jaundice at screening\n* Participants who are taking, or who are expected to need to start within 3 months, a medicine (including traditional or herbal) which may interact with acoziborole and which cannot be stopped or adjusted (please refer to investigator manual or contact DNDi)","ALL","11 Years",{"count":107,"type":108},2500,"ESTIMATED","INTERVENTIONAL",[111],"PHASE3","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.\n\nWe 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.\n\nThe 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.",[114],"Trypanosomiasis; African, Due to Trypanosoma Brucei Gambiense, Gambiense",[116],"acoziborole, elimination of transmission, seropositive","2026-08-24",{"date":119,"type":120},"2026-08-27","ACTUAL",{"date":122,"type":120},"2024-03-15",{"date":124,"type":108},"2027-12-30",{"name":5,"class":6},1]