Randomised, Open Label, Multicentre, Non-inferiority Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan
Who is this study for? Patients in Pakistan with cutaneous leishmaniasis caused by leishmania tropica
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 10
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Pakistan
Kuchlak Primary Health Care Centre (MCH)
RECRUITING
Kuchlagh
Shaheed Mohtarma Benazir Bhutto General Hospital
RECRUITING
Quetta
Contact Information
Primary
Suzette Sabine Kämink
s.s.kamink@gmail.com
+31643690015
Backup
Koert Ritmeijer
koert.ritmeijer@oca.msf.org
+31 6 24453143
Time Frame
Start Date:2022-10-07
Estimated Completion Date:2026-01-31
Participants
Target number of participants:832
Treatments
Experimental: monotherapy miltefosine
Miltefosine capsules (Impavido®) 2.5 mg/kg daily PO for 28 days \<30 kg BW allometric miltefosine dose based on fat-free mass. (approx. 2.5 mg/kg); \>30 - ≤44kg BW: 100 mg/day BID; ≥45kg BW 150mg TDS
Experimental: Thermotherapy
Thermotherapy (ThermoMed 1.8 ®) 50°C for 30 seconds, 1 session
Experimental: Combination miltefosine and thermotherapy
Miltefosine capsules 2.5 mg/kg daily PO for 21days, and thermotherapy 50°C for 30 seconds, one session on day 1 of the miltefosine.