[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medecins Sans Frontieres, Netherlands\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100641722","polyvalent-antivenom-premium-panaf-for-snakebite-envenoming-in-ethiopia-100641722",false,"NCT07659002","Polyvalent Antivenom (Premium-PANAF) for Snakebite Envenoming in Ethiopia","A Prospective Cohort Study of Polyvalent Antivenom (Premium-PANAF) for Snakebite Envenoming in Ethiopia","Inclusion criteria\n\n* Snakebite envenoming patients who receive Premium-PANAF antivenom\n* Patients who have given written informed consent .\n\nExclusion criteria\n\n* Snakebite envenoming patients who do not receive Premium-PANAF antivenom\n* Patients referred from other centres who already received other antivenom treatment\n* Patients who are unable or unwilling to give informed consent","ALL",{"count":18,"type":19},600,"ESTIMATED","42 Days","OBSERVATIONAL","Snakebite Envenomation is recognised as a Neglected Tropical Diseases with high lethality in Sub-Saharan Africa. The current syndromic treatment approach is also fraught by supply pipeline constraints and need for cold-chain, thus negatively impacting outcomes in resource limited settings.\n\nDespite the lack of clinical outcome data from studies in humans, after a comprehensive risk-benefit assessment, the World Health Organisation (WHO), in May 2023, recommended the use of Premium-PANAF polyvalent snake antivenom that is lyophilised, and therefore does not require cold-chain conditions. Médecins Sans Frontières (MSF) also updated its treatment protocol with Premium PANAF being standard of care since June 2025 at Abdurafi (Midre Genet) Health Centre in north west Ethiopia.\n\nReal-world effectiveness by means of Phase IV post marketing studies or pharmacovigilance programmes in countries where it has recently been rolled out is not yet available. This prospective observational cohort study, with a capped sample size of 600 patients, would thus provide much needed evidence on the safety and effectiveness of Premium-PANAF in resource limited settings to help inform national and international treatment guidelines.",[24],"Snake Envenomation",[26,27,28,29,30,31,32],"prospective observational cohort","Ethiopia","treatment","safety","effectiveness","antivenom","snakebite","RECRUITING","2026-06-15",{"date":36,"type":37},"2026-06-22","ACTUAL",{"date":39,"type":37},"2025-06-02",{"date":41,"type":19},"2026-09-01",{"name":43,"class":44},"Medecins Sans Frontieres, Netherlands","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":5},"100383122","phase-3-randomised-clinical-trial-for-new-treatment-modalities-for-cutaneous-leishmaniasis-caused-by-leishmania-tropica-in-pakistan-100383122","NCT04268524","Randomised Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan","Randomised, Open Label, Multicentre, Non-inferiority Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan","Inclusion Criteria:\n\n* Male and female patients with clinical and laboratory confirmed CL, and who can be treated with localised intralesional antimonial injections and\u002For thermotherapy:\n* lesion size ≥0.5 cm and ≤4 cm\n* not located on the ear, nose, near to the eye or mucosal membranes, on joints, or on a location that in the opinion of the principle investigator (PI) is difficult to apply thermotherapy (TT) or intralesional (IL) injections\n* patient with ≤4 lesions\n* duration of lesions less than five months by patient history\n* Patients who have signed the informed consent form.\n\nExclusion Criteria:\n\n* Pregnant women and breast feeding women\n* Non-pregnant women in reproductive age refusing effective (injectable) contraception for a period of five months\n* Patients \\\u003C10years old\n* Patients who cannot be treated with localised IL antimonial injections or TT (patients with more than 4 lesions, lesions \\>4cm in diameter, or located on joints, lips, nose, ears or near eyes)\n* History of clinically significant medical problems or treatment that might interact with the study treatment and interact with wound healing, such as diabetes, vascular diseases and any immunocompromising condition\n* Within eight weeks of trial D1 received treatment for leishmaniasis with any medication\n* History of known or suspected hypersensitivity of idiosyncratic reactions to trial medication or excipients\n* Has laboratory values at screening: serum creatinine above normal level; ALT 3 times above normal range\n* Patient who is not willing to attend the trial visits, or is not able to comply with follow-up visits up to three months.\n* Known history of drug addiction and\u002For alcohol abuse","10 Years",{"count":55,"type":19},832,"INTERVENTIONAL",[58],"PHASE3","randomised control clinical trial to evaluate miltefosine, thermotherapy and the combination miltefosine-thermotherapy are effective, safe and tolerable alternative treatment options to treat cutaneous leishmaniasis caused by L. tropica, in Pakistan compared to the standard of care.",[61],"Old World Cutaneous Leishmaniasis",[63,64],"miltefosine","Thermotherapy","2025-05-06",{"date":67,"type":37},"2025-05-09",{"date":69,"type":37},"2022-10-07",{"date":71,"type":19},"2026-01-31",{"name":43,"class":44},""]