RecruitingPhase 3NCT04268524
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
Sponsor
Medecins Sans Frontieres, Netherlands
Enrollment
832 participants
Start Date
Oct 7, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 10 Years
Inclusion Criteria6
- Male and female patients with clinical and laboratory confirmed CL, and who can be treated with localised intralesional antimonial injections and/or thermotherapy:
- lesion size ≥0.5 cm and ≤4 cm
- 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
- patient with ≤4 lesions
- duration of lesions less than five months by patient history
- Patients who have signed the informed consent form.
Exclusion Criteria10
- Pregnant women and breast feeding women
- Non-pregnant women in reproductive age refusing effective (injectable) contraception for a period of five months
- Patients <10years old
- 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)
- 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
- Within eight weeks of trial D1 received treatment for leishmaniasis with any medication
- History of known or suspected hypersensitivity of idiosyncratic reactions to trial medication or excipients
- Has laboratory values at screening: serum creatinine above normal level; ALT 3 times above normal range
- Patient who is not willing to attend the trial visits, or is not able to comply with follow-up visits up to three months.
- Known history of drug addiction and/or alcohol abuse
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Interventions
COMBINATION_PRODUCTdrug: miltefosine with thermotherapy
see previous
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04268524