[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Drugs for Neglected Diseases\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100592725","phase-2-a-clinical-trial-to-investigate-efficacy-safety-and-pharmacokinetics-pk-of-two-lxe408-oral-regimens-and-oral-miltefosine-as-active-control-in-participants-aged--18-years-old-with-localized-cutaneous-leishmaniasis-in-the-region-of-the-americas-amr-100592725",false,"NCT06997159","A Clinical Trial to Investigate Efficacy, Safety and Pharmacokinetics (PK) of Two LXE408 Oral Regimens and Oral Miltefosine as Active Control in Participants Aged ≥ 18 Years Old With Localized Cutaneous Leishmaniasis in the Region of the Americas (AMR).","A Randomized, Multicentre, Observer-blind Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of Two LXE408 Regimens and Miltefosine as an Active Control in Patients With Localized Cutaneous Leishmaniasis in the Region of the Americas (AMR).","Inclusion Criteria:\n\n1. Participant must be aged ≥18 years old and weighing \\> 50kg\n2. Participant with first episode of CL fulfilling the following characteristics:\n\n   * ≤ 6 lesions\n   * At least one lesion of \\> 50 mm2 of area\n   * a history of CL of no longer than 6 months\n3. a diagnosis of CL confirmed by at least one of the following methods:\n\n   * microscopic identification of amastigotes in stained lesion tissue, or\n   * demonstration of Leishmania by PCR, or\n   * positive culture for promastigotes\n4. In the opinion of the investigator, the participant is capable of understanding and complying with the protocol, including visits up to 6 months after study start.\n5. Written informed consent must be obtained before any study protocol specific assessment is performed other than procedures performed as part of standard of care.\n\nParticipants must be able to give written informed consent.\n\nExclusion Criteria:\n\n1. Female with a positive blood pregnancy test at screening or who is breastfeeding, lactating or women of childbearing potential (defined as women physiologically capable of becoming pregnant) who does not agree to use two methods of contraception, one barrier method and one highly effective method. In Brazil: for 30 days prior to the treatment onset and up to D180 visit. In Panama: during treatment period up to D180 visit.\n2. Sexually active male, including those post-vasectomy, unwilling to use a condom during intercourse with female partner while taking the investigational drug and for 5 days, after stopping the investigational drug.\n3. Has diagnosis or suspected diagnosis of mucocutaneous, disseminated or diffuse leishmaniasis based on physical exam.\n4. Current clinically significant medical problems (e.g., cardiac, renal, hepatic, pancreatic diseases, current cutaneous conditions that may interfere with CL evolution or healing, past and current ocular disorders, especially keratitis, uveitis, scleritis), including any immunocompromising condition (such as having a known diagnosis for HIV, transplanted patients, those in treatment for auto immune diseases, patients receiving immunosuppressant, immunobiological or antineoplastic treatments).\n5. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).\n6. Participants newly diagnosed with HIV infection on the basis of the trial screening testing or other recent testing (\\\u003C 6 months) are excluded. Participants with documented stable HIV infection are allowed to participate in the study. Stable HIV infection is defined as: clinically stable with no signs or symptoms of advanced HIV infection and taking their current anti-retroviral therapy for ≥ 6 months with an undetectable viral load for ≥ 6 months. Participants taking anti-retroviral therapy prohibited in Section 6.9.4 are excluded.\n7. Participants with active infectious conditions, such as tuberculosis, or history or active hepatitis B virus (HBV) infection or hepatitis C virus (HCV) infection are excluded. Active HBV is defined as a positive HBV surface antigen (HBsAg) test, or if standard local practice, a positive HBV core antigen test and all participants with a positive HBV core antibody screening test must have HBsAg measured. Active HCV is defined as having detectable HCV RNA and all participants with a positive HCV antibody test at screening must have HCV RNA measured. Participants taking therapy for HBV or HCV are excluded.\n8. ECG abnormalities, either historic (no longer present) or current which, in the view of the investigator, indicate a significant risk to study participation. These include, but are not limited to, the following:\n\n   * Clinically significant cardiac arrhythmias (e.g., sustained ventricular tachycardia and clinically significant second- or third-degree AV block without a pacemaker).\n   * QTcF ≥450 ms.\n   * History of familial long QT syndrome or known family history of Torsades de Pointes.\n   * Resting heart rate (physical exam or 12 lead ECG) \\\u003C60 bpm.\n9. Participants who are receiving or have received antileishmanial medication, or prohibited medication or any medication that might interfere with the therapeutic response or cause harmful interactions with study medications, as defined in concomitant treatments in Section 6.9.4.\n10. Has laboratory values at screening as follows:\n\n    Serum creatinine: ≥1.5 times ULN\\*, ALT, AST, GGT, ALP: \\>1.5 times above upper normal level\\*. Total bilirubin \\> 1.5 times ULN\\* amylase or lipase \\> 1.5 times ULN\\*\n\n    \\*Normal ranges obtained from local laboratory.\n11. Known history of addiction\u002F alcohol abuse.\n12. Hypersensitivity to miltefosine or any study medication excipients.\n13. Participants with Sjogren-Larsson Syndrome.","ALL","18 Years",{"count":19,"type":20},250,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this clinical trial is to measure efficacy, safety and pharmacokinetics (PK) of two LXE408 oral regimens and oral miltefosine tablets as active control in localized cutaneous leishmaniasis in the region of the Americas (AMR), and assess its suitability for use in monotherapy for the treatment of patients with cutaneous leishmaniasis (CL).",[26],"Localized Cutaneous Leishmaniasis",[26],"NOT_YET_RECRUITING","2026-04-29",{"date":31,"type":32},"2026-05-05","ACTUAL",{"date":34,"type":20},"2026-06-15",{"date":36,"type":20},"2028-04-05",{"name":38,"class":39},"Drugs for Neglected Diseases","OTHER",5,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100555486","mycetoma-retrospective-data-collection-100555486","NCT06512714","Mycetoma Retrospective Data Collection","Estimating the Burden of Mycetoma: A Retrospective Analysis of Hospital Records","Inclusion Criteria:\n\n* Any patient given a diagnosis of mycetoma in a medical, radiologic, or laboratory record.\n\nExclusion Criteria:\n\n* Patients with illegible or inaccessible health records.",{"count":49,"type":20},1600,"OBSERVATIONAL","The goal of this retrospective observational study is to describe mycetoma cases detected in health care facilities in India and Senegal in a 10-year period. The main objectives are to:\n\n* Determine the number of mycetoma cases diagnosed per year and trends over time.\n* Describe characteristics of diagnosed mycetoma cases.\n\n  1. Describe demographic characteristics of patients with mycetoma.\n  2. Describe clinical characteristics of patients with mycetoma upon initial presentation and over time.\n* Assess etiology of mycetoma cases.\n* Characterize clinical management of mycetoma cases.\n\n  1. Characterize approaches to diagnosis of mycetoma.\n  2. Investigate types and durations of treatments (including medical and surgical approaches) utilized to treat mycetoma cases.\n  3. Describe clinical outcomes among patients with mycetoma.\n\nThe study team will review all available medical, laboratory and radiologic records of identified mycetoma cases and use data collection forms to extract relevant data.",[53],"Mycetoma","RECRUITING","2024-07-31",{"date":57,"type":32},"2024-08-01",{"date":59,"type":32},"2024-06-20",{"date":61,"type":20},"2024-08-31",{"name":38,"class":39},2,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":72,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":4},"100543523","phase-3-stop-transmission-of-gambiense-human-african-trypanosomiasis-stroghat-100543523","NCT06356974","Stop Transmission of Gambiense Human African Trypanosomiasis (STROgHAT)","An Intervention Study to Evaluate the Impact of Treating gHAT Seropositive Subjects With Acoziborole on Transmission of T.b. Gambiense, and Obtain Further Safety Data on Acoziborole in gHAT Seropositive 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\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\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)","11 Years",{"count":74,"type":20},2500,[76],"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\nThe 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.\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.",[79],"Human African Trypanosomiasis",[81],"acoziborole, elimination of transmission, seropositive","2024-04-04",{"date":84,"type":32},"2024-04-10",{"date":86,"type":20},"2024-04-08",{"date":88,"type":20},"2027-12-30",{"name":38,"class":39},""]