Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this randomized, open label clinical trial is to determine if oral miltefosine is a safe and effective alternative, compared with parenteral meglumine antimoniate for the treatment of pediatric Cutaneous caused by L. Viannia species in Colombia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pilot Study: Miltefosine Gel (G-MTF) in Patients With Cutaneous Leishmaniasis

NCT07149753

Cutaneous Leishmaniasis Cutaneous Leishmaniasis, American Topical Administration

NOT_YET_RECRUITING PHASE1

Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

NCT00600548

Treatment of Cutaneous Leishmaniasis in Brazil.

COMPLETED PHASE2

Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia.

NCT00471705

Cutaneous Leishmaniasis

COMPLETED PHASE3

Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia

NCT00233545

Cutaneous Leishmaniasis

COMPLETED PHASE2

Short Course of Miltefosine and Antimony to Treat Cutaneous Leishmaniasis in Bolivia

NCT00537953

Cutaneous Leihmaniasis

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cutaneous Leishmaniasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Oral administration of Miltefosine, doses: 1,5mg to 2,5mg/kg/day, during 28 days.

presentation: capsulas 10mg and 50mg Miltefosine (Impavido®)

Group Type ACTIVE_COMPARATOR

Miltefosine

Intervention Type DRUG

Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days.

Group 2

Administration of Parenteral meglumine antimoniate, Glucantime® Amp 5ml (83mg/ml). Dosage:20mg/kg/day, during 20 days.

Group Type ACTIVE_COMPARATOR

Meglumine antimoniate

Intervention Type DRUG

Parenteral meglumine antimoniate Amp of 5ml (83mg/ml). Dosage: 20mg/kg/day one doses IM, during 20 days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Miltefosine

Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days.

Intervention Type DRUG

Meglumine antimoniate

Parenteral meglumine antimoniate Amp of 5ml (83mg/ml). Dosage: 20mg/kg/day one doses IM, during 20 days.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Miltefosine cap 10mg and 50mg, Impavido® (Zentaris) Glucantime® of Aventis: Amp of 5ml (83mg/ml).

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 2 to 12 years of age (inclusive)
* Parasitologically confirmed CL
* Availability to receive supervised treatment for 28 days (i.e., directly observed therapy, to ensure the therapy is appropriately administered and received - e.g., the miltefosine is "swallowed")
* Availability to return for follow-up visits for at least 6 months after treatment is initiated

Exclusion Criteria

* Weight under 10kg
* Previous use of SbV, miltefosine or other antileishmanial therapy
* Simultaneous mucosal lesions suggestive of or proven to be mucosal leishmaniasis
* If a girl, ability to reproduce (history of menarche)
* Relative or absolute contraindications for the use of SbV drugs or miltefosine, including history of cardiac, renal or hepatic disease
* Patients with pretreatment haemoglobin \<10g/dl or blood urea nitrogen (BUN), serum creatinine, ALT, AST or amylase values that exceed the upper limit of normal
* If living in Malaria endemic areas (eg. Tumaco) only: A positive malaria thick smear

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No