Old World Cutaneous Leishmaniasis Clinical Trial
Official title:
Randomised, Open Label, Multicentre, Non-inferiority Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan
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.
Status | Not yet recruiting |
Enrollment | 832 |
Est. completion date | December 30, 2022 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Medecins Sans Frontieres, Netherlands |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The initial clinical cure rate in each study arm | Initial Cure: Ulcerated lesions: 100% re-epithelialization of the lesion(s) Non-Ulcerated lesions: flattening and/or no signs of induration of the lesion(s) by Day 91. | by Day 91. | |
Primary | Adverse events | Frequency, severity and seriousness of AEs by treatment group | by Day 91. | |
Secondary | initial cure and no relapse | The proportion of patients in each study arm who have fulfilled the criteria of initial cure and have no relapse | initial cure at D91 and have no relapse by D120. | |
Secondary | 100% re-epithelialized/ flattened | The number of patients with lesions 100% re-epithelialized/ flattened at each measurement time point. | at visit until D120 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01536795 -
A Study to Evaluate the Efficacy and Tolerance of WR279,396 for Old World Cutaneous Leishmaniasis
|
Phase 2 |