Evidence map›Paper›PMID 27956421›Full record

Trial reportAntimicrobial agents and chemotherapy2017

Pharmacokinetics of Miltefosine in Children and Adults with Cutaneous Leishmaniasis.

María Del Mar Castro, Maria Adelaida Gomez, Anke E Kip, Alexandra Cossio, Eduardo Ortiz, Adriana Navas, Thomas P C Dorlo, Nancy Gore Saravia

Registry-linked trialOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07149753 (Pilot Study), which is not on this map. Cited by 39 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 1 pooled it
4.5field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07149753 phase1not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Pilot Study: Safety and Therapeutic Dose of a Miltefosine Gel (G-MTF) in Patients With Uncomplicated Cutaneous Leishmaniasis (NCCL)

TypeinterventionalSponsorUniversidad Industrial de SantanderRan2026 to 2026Enrolled15ConditionsCutaneous Leishmaniasis, Cutaneous Leishmaniasis, American, Topical AdministrationArmsMILTEFOSINE gel
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 1 synthesis or guideline pooled it, 58 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Genomic Insights ofOpen forum infectious diseases · 2026
    Review
  10. Article
  11. Article
  12. Cutaneous leishmaniasis in Afghanistan.Transactions of the Royal Society of Tropical Medicine and Hygiene · 2025
    Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Miltefosine: A Repurposing Drug against Mucorales Pathogens.Journal of fungi (Basel, Switzerland) · 2023
    Article
  19. Article
  20. Efficacy of oleylphosphocholine in experimental cutaneous leishmaniasis.The Journal of antimicrobial chemotherapy · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 3 countries.

María Del Mar CastroCentro Internacional de Entrenamiento e Investigaciones Médicas, Cali, Colombia.
Maria Adelaida GomezCentro Internacional de Entrenamiento e Investigaciones Médicas, Cali, Colombia.
Anke E KipDivision of Pharmacoepidemiology & Clinical Pharmacology, Utrecht University, Utrecht, the Netherlands.
Alexandra CossioCentro Internacional de Entrenamiento e Investigaciones Médicas, Cali, Colombia.
Eduardo OrtizCentro Internacional de Entrenamiento e Investigaciones Médicas, Cali, Colombia.
Adriana NavasCentro Internacional de Entrenamiento e Investigaciones Médicas, Cali, Colombia.
Thomas P C DorloDivision of Pharmacoepidemiology & Clinical Pharmacology, Utrecht University, Utrecht, the Netherlands t.p.c.dorlo@uu.nl saravian@cideim.org.co.
Nancy Gore SaraviaCentro Internacional de Entrenamiento e Investigaciones Médicas, Cali, Colombia t.p.c.dorlo@uu.nl saravian@cideim.org.co.
Centro Internacional de Entrenamiento e Investigaciones Medicas · COThe Netherlands Cancer Institute · NLUppsala University · SE

Funding

Vector/Host-Parasite Interface of Leishmaniasis in ColombiaD43TW006589 · FIC · YALE UNIVERSITY · PI GORE SARAVIA, NANCY, TSCHUDI, CHRISTIAN · 2003 to 2024
$4.3M
Improved Treatment of American Cutaneous Leishmaniasis by ImmunomodulationR01AI093775 · NIAID · YALE UNIVERSITY · PI GORE SARAVIA, NANCY, MCMAHON PRATT, DIANE · 2011 to 2014
$2.6M
Macrophage drug transport and metabolism in the outcome of antileishmania therapyR01AI104823 · NIAID · CENTRO INTERNACIONAL (CIDEIM) · PI GOMEZ, MARIA ADELAIDA · 2013 to 2017
$674k
FIC NIH HHS D43 TW006589NIAID NIH HHS R01 AI093775NIAID NIH HHS R01 AI104823
6 · The paper itself

Abstract

An open-label pharmacokinetics (PK) clinical trial was conducted to comparatively assess the PK and explore the pharmacodynamics (PD) of miltefosine in children and adults with cutaneous leishmaniasis (CL) in Colombia. Sixty patients, 30 children aged 2 to 12 years and 30 adults aged 18 to 60 years, were enrolled. Participants received miltefosine (Impavido) at a nominal dose of 2.5 mg/kg/day for 28 days. Miltefosine concentrations were measured in plasma and peripheral blood mononuclear cells by liquid chromatography-tandem mass spectrometry of samples obtained during treatment and up to 6 months following completion of treatment, when therapeutic outcome was determined. Fifty-two patients were cured, 5 pediatric patients failed treatment, and 3 participants were lost to follow-up.

Indexed as

AdolescentAdultAntiprotozoal AgentsArea Under CurveChildChild, PreschoolDrug Administration ScheduleFemaleHumansLeishmania braziliensisLeishmania guyanensisLeishmaniasis, CutaneousLeukocytes, MononuclearMaleMiddle AgedParasitic Sensitivity TestsAntiprotozoal AgentsmiltefosinePhosphorylcholinechildrencutaneous leishmaniasisintracellular miltefosinemiltefosinepharmacokinetics

Identifiers

PMID27956421
PMCPMC5328512
OpenAlexW2567041620

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.