NCT01462500

Brief Summary

The purpose of this study is to determine the pharmacokinetics of miltefosine in children and adults with cutaneous leishmaniasis in plasma and intracellularly, and its relation with the parasitologic response. The results will provide pharmacologic bases to optimize the use of miltefosine for the treatment of cutaneous leishmaniasis, and will provide the knowledge base to assess the impact of pharmacokinetic behavior in children and adults on the emergence of drug resistance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 22, 2016

Status Verified

August 1, 2016

Enrollment Period

2.6 years

First QC Date

October 25, 2011

Last Update Submit

August 18, 2016

Conditions

Cutaneous Leishmaniasis

Keywords

Miltefosinepharmacokineticscutaneous leishmaniasis

Outcome Measures

Primary Outcomes (2)

  • Intracellular and plasma concentration of miltefosine

    Participants will be followed up to 26 weeks.

  • Parasite burden in lesions and extralesional tissues.

    Participants will be followed up to 26 weeks

Study Arms (1)

Miltefosine

EXPERIMENTAL

Miltefosine PO at a dose of 1.8-2.5 mg/kg/day for 28 days

Drug: Miltefosine

Interventions

MiltefosineDRUG

Children (2-12 years of age) and adults (18-60 years of age) will receive Miltefosine PO at a dose of 1.8-2.5 mg/kg/day for 28 days.

Also known as: pharmacokinetic
Miltefosine

Eligibility Criteria

Age2 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age: 2-12 years of age, or 18-60 years of age
  • Weight greater than 10 kg
  • Parasitologic confirmation of cutaneous leishmaniasis
  • Normal hepatic and kidney function

You may not qualify if:

  • Pregnant or lactating women, and women who are planning to conceive during the study or that reject the use of birth control methods.
  • Use of drugs with antileishmanial potential during the previous 6 months, including pentavalent antimonials, amphotericin B, miltefosine, and pentamidine
  • Mucocutaneous or visceral leishmaniasis
  • For female children, menses or other evidence of reproductive maturity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas

Cali, Valle del Cauca Department, 5930, Colombia

Location

Related Publications (6)

  • Sindermann H, Engel J. Development of miltefosine as an oral treatment for leishmaniasis. Trans R Soc Trop Med Hyg. 2006 Dec;100 Suppl 1:S17-20. doi: 10.1016/j.trstmh.2006.02.010. Epub 2006 May 26.

    PMID: 16730362BACKGROUND

  • Dorlo TP, van Thiel PP, Huitema AD, Keizer RJ, de Vries HJ, Beijnen JH, de Vries PJ. Pharmacokinetics of miltefosine in Old World cutaneous leishmaniasis patients. Antimicrob Agents Chemother. 2008 Aug;52(8):2855-60. doi: 10.1128/AAC.00014-08. Epub 2008 Jun 2.

    PMID: 18519729BACKGROUND

  • Anderson BJ, Allegaert K, Holford NH. Population clinical pharmacology of children: general principles. Eur J Pediatr. 2006 Nov;165(11):741-6. doi: 10.1007/s00431-006-0188-y. Epub 2006 Jun 29.

    PMID: 16807730BACKGROUND

  • Berman JJ. Treatment of leishmaniasis with miltefosine: 2008 status. Expert Opin Drug Metab Toxicol. 2008 Sep;4(9):1209-16. doi: 10.1517/17425255.4.9.1209.

    PMID: 18721114BACKGROUND

  • 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.

    PMID: 28379954DERIVED

  • Castro MD, Gomez MA, Kip AE, Cossio A, Ortiz E, Navas A, Dorlo TP, Saravia NG. Pharmacokinetics of Miltefosine in Children and Adults with Cutaneous Leishmaniasis. Antimicrob Agents Chemother. 2017 Feb 23;61(3):e02198-16. doi: 10.1128/AAC.02198-16. Print 2017 Mar.

    PMID: 27956421DERIVED

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

miltefosinePharmacogenomic Variants

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Polymorphism, GeneticGenetic VariationGenetic Phenomena

Study Officials

  • Nancy C Saravia, PhD

    Centro Internacional de Entrenamiento e Investigaciones Médicas, CIDEIM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2011

First Posted

October 31, 2011

Study Start

October 1, 2011

Primary Completion

May 1, 2014

Study Completion

December 1, 2015

Last Updated

August 22, 2016

Record last verified: 2016-08

Locations

CO(1)