Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether miltefosine is effective in the treatment of mucosal leishmaniasis compared to meglumine antimoniate, the standard treatment.

Clinical Trial Description

Mucosal leishmaniasis is a rare form of the disease, that affects only 6% of the patients with cutaneous leishmaniasis in the New World. It causes deformities and may be lethal if not treated. It is part of the neglected tropical diseases because on the past sixty years there was few progress regarding other treatment options or improvement at quality of life of its patients. Also, there was little interest from the pharmaceutical industry and government authorities to develop new researches. The standard treatment, meglumine antimoniate, is toxic, invasive, requires trained personnel and has many adverse effects and restrictions. On the other hand, miltefosine is the first oral drug to demonstrate efficacy against mucocutaneous leishmaniasis. Few clinical trials have being performed in Central and South American countries, but so far, just one involved mucosal leishmaniasis patients, and compared miltefosine to amphotericin B. None studies comparing its efficacy to the standard treatment have being done. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01377974
Study type	Interventional
Source	Brasilia University Hospital
Contact
Status	Completed
Phase	Phase 2
Start date	July 2009
Completion date	December 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03641339` - Defining Skin Immunity of a Bite of Key Insect Vectors in Humans	N/A
Completed	`NCT04504435` - Safety, Tolerability and Pharmacokinetics (PK) Investigation of GSK3494245 in Healthy Participants	Phase 1
Completed	`NCT00004755` - Allopurinol, Glucantime, or Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil	Phase 2
Completed	`NCT00657618` - Use of Sodium Stibogluconate as a Treatment for Leishmaniasis	Phase 1/Phase 2
Completed	`NCT04512742` - A Clinical Study to Develop a Controlled Human Infection Model Using Leishmania Major-infected Sand Flies	N/A
Recruiting	`NCT00344188` - Diagnosis and Treatment of Leishmania Infections
Active, not recruiting	`NCT03009422` - Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis.	N/A
Recruiting	`NCT05449717` - Incidence of Relapse and Post-Kala-Azar Dermal Leishmaniasis in South Sudan
Recruiting	`NCT06307171` - Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers	N/A
Completed	`NCT01751048` - LEISH-F3 + GLA-SE and the LEISH-F3 + MPL-SE Vaccine	Phase 1
Terminated	`NCT06124144` - Safety and Drug Absorption of Orally Administered Oleylphosphocholine (OlPC) in Healthy Adults	Phase 1
Completed	`NCT00662012` - Sodium Stibogluconate Treatment of Leishmaniasis	Phase 2
Completed	`NCT03993093` - Prevalence of HIV +ve Cases With AIDS Defining Opportunistic Infections Among ART Naive Patients Attending ART Centre
Recruiting	`NCT03784248` - Mediterranean Visceral Leishmaniasis With Leishmania Infantum
Withdrawn	`NCT02429505` - Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry
Completed	`NCT02656797` - Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis	Phase 2
Completed	`NCT01484548` - Phase 1 LEISH-F3 Vaccine Trial in Healthy Adult Volunteers	Phase 1
Completed	`NCT01300975` - Intralesional Antimony for Bolivian Cutaneous Leishmaniasis	Phase 2
Completed	`NCT03294161` - Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis	Phase 2
Completed	`NCT00401557` - Mechanisms Relating to the Distinct in Vitro Susceptibility of Human Macrophages to L. Viannia Infection