Clinical trial NCT00487253: Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia
Official title: Randomized Clinical Trial of the Efficacy and Tolerability of Oral Miltefosine Versus Parenteral Antimony for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cutaneous Leishmaniasis
Keywords: Cutaneous Leishmaniasis
Leishmania Viannia
Pediatric
Miltefosine
Randomized
Colombia
Lead sponsor: Centro Internacional de Entrenamiento e Investigaciones Médicas
Sponsor class: OTHER
Collaborators: name: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
name: INS
name: Instituto Nacional de Dermatología Centro dermatológico Federico Lleras Acosta
First posted: 2007-06-18
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome measure will be the proportion of "Therapeutic Failures" diagnosed during the final (week 26) visit or before, according to defined clinical criteria.
timeFrame: 26 weeks (6 months)
measure: Evidence of clinical or laboratory toxicity during the treatment period.
timeFrame: During the treatment period (20 or 28 days)
Secondary outcomes:
measure: Proportion of patients with "parasitologic" response 26 weeks after the initiation of treatment.
timeFrame: 26 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Centro Internacional de Entrenamiento e Investigaciones Médicas
name: Luisa Consuelo Rubiano, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castro MDM, Cossio A, Velasco C, Osorio L. Risk factors for therapeutic failure to meglumine antimoniate and miltefosine in adults and children with cutaneous leishmaniasis in Colombia: A cohort study. PLoS Negl Trop Dis. 2017 Apr 5;11(4):e0005515. doi: 10.1371/journal.pntd.0005515. eCollection 2017 Apr.
citation: Rubiano LC, Miranda MC, Muvdi Arenas S, Montero LM, Rodriguez-Barraquer I, Garcerant D, Prager M, Osorio L, Rojas MX, Perez M, Nicholls RS, Gore Saravia N. Noninferiority of miltefosine versus meglumine antimoniate for cutaneous leishmaniasis in children. J Infect Dis. 2012 Feb 15;205(4):684-92. doi: 10.1093/infdis/jir816. Epub 2012 Jan 11.