Combination, Miltefosine Monotherapy & Antimonial Therapy for Cutaneous Leishmaniasis in New World

• Status: Recruiting
• Trial end date: 2023-03-30
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates if the combination of thermotherapy (one application, 50⁰C for 30") and 3 weeks of miltefosine is safe and have a comparable cure rate with the current recommended first line treatments comprising meglumine antimoniate for 3 weeks or miltefosine monotherapy for 4 weeks, for the treatment of uncomplicated cutaneous leishmaniasis cases in the New World.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drugs for Neglected Diseases
• Treatments: Meglumine Antimoniate; Miltefosine

Criteria

Inclusion Criteria:

• Males and females, aged ≥12 and ≤60 years old (upper age limit according to local regulations), and weighing ≥ 30Kg.

• Patient with a confirmed diagnosis of CL in at least one lesion by at least one of the following methods: 1) microscopic identification of amastigotes in stained lesion tissue, or 2) demonstration of Leishmania by Polymerase Chain Reaction (PCR), or 3) positive culture for promastigotes.

• Patient has a lesion that satisfies the following criteria:

• Lesion size ≥ 0.5 cm and ≤ 4 cm (longest diameter).

• not located on the ear, face, close to mucosal membranes, or on a location that in the opinion of the Principal Investigator (PI) is difficult to apply the TT.

• Patient with ≤ 4 CL lesions.

• Duration of lesion less than 4 months by patient history.

• Patient able to give written informed consent/ assent form.

• In the opinion of the investigator, the patient is capable of understanding and complying with the protocol.

Exclusion Criteria:

• Female with a positive urine or blood pregnancy test at screening or who is breast feeding or female at fertile age who does not agree to take appropriate effective contraception during treatment period and up to D180 visit. In Brazil: female at fertile age who does not agree to use two effective methods of contraception: one barrier method and one highly effective method (defined in section 8.2.4) 30 days prior to the treatment onset and up to D180 visit.

• History of clinically significant medical problems / treatment that might interact, either negatively or positively, with treatment of cutaneous leishmaniasis including any immunocompromising condition.

• Within 8 weeks (56 days) of Day 1, received treatment for the entry lesion leishmaniasis with any medication including antimonials likely, in the opinion of the PI, to modify the course of the Leishmania infection.

• Has diagnosis or suspected diagnosis of mucocutaneous leishmaniasis based on physical exam.

• Electrocardiogram (ECG) at screening: QTc above 400msec for men and 450msec for women.

• Has laboratory values at screening as follows:

• Serum amylase and lipase: 2 times above upper normal level*,

• Serum creatinine: above upper normal level*.

• Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST): 3 times above upper normal level*.

• Normal ranges obtained from local laboratory.

• Patient who is not willing to attend the study visits or is not able to comply with follow-up visits up to 6 months.

• Known history of addiction/ alcohol abuse.

• Hypersensitivity to miltefosine or antimonial drugs or any study medication excipients.

• Patients with Sjogren-Larson Syndrome.