Evidence map›Paper›PMID 28379954›Full record

ArticlePLoS neglected tropical diseases2017

Risk factors for therapeutic failure to meglumine antimoniate and miltefosine in adults and children with cutaneous leishmaniasis in Colombia: A cohort study.

Maria Del Mar Castro, Alexandra Cossio, Carlos Velasco, Lyda Osorio

3 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in PLoS neglected tropical diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 43 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 1 pooled it
4.5field-weighted citation impact, top 6% 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.

NCT00487253 phase3unknown statusnot on this map

Randomized Clinical Trial of the Efficacy and Tolerability of Oral Miltefosine Versus Parenteral Antimony for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia

TypeinterventionalSponsorCentro Internacional de Entrenamiento e Investigaciones MédicasRan2007 to 2010Enrolled150ConditionsCutaneous LeishmaniasisArmsMiltefosine, Meglumine antimoniate
NCT01462500 phase4completednot on this map

Pharmacokinetics of Miltefosine in Children and Adults: Implications for the Treatment of Cutaneous Leishmaniasis in Colombia.

TypeinterventionalSponsorCentro Internacional de Entrenamiento e Investigaciones MédicasRan2011 to 2015Enrolled60ConditionsCutaneous LeishmaniasisArmsMiltefosine
NCT01464242 phase2 / phase3completednot on this map

Therapeutic Gain of Adding the Immunomodulator Pentoxifylline to the Treatment of Cutaneous Leishmaniasis

TypeinterventionalSponsorCentro Internacional de Entrenamiento e Investigaciones MédicasRan2011 to 2015Enrolled75ConditionsCutaneous LeishmaniasisArmsMeglumine antimonate, Placebo, Pentoxifylline
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.

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  9. Therapeutic potential of iron oxide nanoparticles for cutaneous leishmaniasis: a systematic review ofThe journal of venomous animals and toxins including tropical diseases · 2025
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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

4 authors at 2 institutions in 1 country.

Maria Del Mar CastroCentro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia.ORCID 0000-0002-0485-2919
Alexandra CossioCentro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia.
Carlos VelascoDepartamento de Pediatría, Universidad del Valle, Cali, Colombia.
Lyda OsorioEscuela de Salud Pública, Universidad del Valle, Cali, Colombia.
Centro Internacional de Entrenamiento e Investigaciones Medicas · COUniversidad del Valle · CO

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
FIC NIH HHS D43 TW006589NIAID NIH HHS R01 AI093775
6 · The paper itself

Abstract

introductionReports of therapeutic failure to meglumine antimoniate (MA) and miltefosine in cutaneous leishmaniasis (CL) varies between species, populations and geographic regions. This study aimed to determine the clinical, drug-related factors, and Leishmania species associated with treatment failure in children and adults with cutaneous leishmaniasis.

methodsA cohort study was performed with children (2-12 years old) and adults (18-65 years old) with CL, who have participated in clinical studies at CIDEIM Cali, Tumaco and Chaparral. Incidence of therapeutic failure was estimated by treatment and age groups. Descriptive, bivariate, and multiple logistic regression analyses were performed for the complete cohort and pediatric patients.

resultsTwo hundred and thirty patients were included (miltefosine: 112; MA: 118), of which 60.4% were children and 83.9% were infected with L.V. panamensis. Overall incidence of therapeutic failure was 15.65% (95%CI: 10.92-20.38), and was lower for miltefosine than for MA (8.92%, 95%CI: 3.59-14.26 versus 22.03%, 95%CI:14.48-29.58, p = 0.006). Treatment failure was associated with age ≤8 years (OR: 3.29; 95%CI: 1.37-7.89), disease duration ≤1 month (OR: 3.29; 95%CI: 1.37-7.89), regional lymphadenopathy (OR: 2.72; 95%CI: 1.10-6.70), treatment with MA (OR: 3.98; 95%CI: 1.66-9.50), and adherence <90% (OR: 3.59; 95%CI: 1.06-12.11). In children, higher Z-score of height/age was a protective factor (OR: 0.58; 95%CI: 0.36-0.93), while treatment with MA was a risk factor (OR: 40.82; 95%CI: 2.45-677.85), demonstrating significant interaction with age (p = 0.03).

conclusionsClinical and drug-related factors determine therapeutic failure in CL. High risk of failure in children treated with MA indicates the need to reconsider this drug as first line treatment in this population.

trial registrationClinical trial registration: NCT00487253 Clinical trial registration: NCT01462500 Clinical trial registration: NCT01464242.

Indexed as

AdolescentAdultAntiprotozoal AgentsChildChild, PreschoolCohort StudiesColombiaFemaleHumansLeishmaniaLeishmaniasis, CutaneousMaleMeglumineMeglumine AntimoniateMiddle AgedOrganometallic CompoundsAntiprotozoal AgentsMeglumineMeglumine AntimoniatemiltefosineOrganometallic CompoundsPhosphorylcholine

Identifiers

PMID28379954
PMCPMC5393627
OpenAlexW2604384082

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.