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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 04; 11(4):e0005515.PN

Abstract

INTRODUCTION

Reports 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.

METHODS

A 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.

RESULTS

Two 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).

CONCLUSIONS

Clinical 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 REGISTRATION

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

Authors+Show Affiliations

Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia. Escuela de Salud Pública, Universidad del Valle, Cali, Colombia.Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia.Departamento de Pediatría, Universidad del Valle, Cali, Colombia.Escuela de Salud Pública, Universidad del Valle, Cali, Colombia.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28379954

Citation

Castro, Maria Del Mar, et al. "Risk Factors for Therapeutic Failure to Meglumine Antimoniate and Miltefosine in Adults and Children With Cutaneous Leishmaniasis in Colombia: a Cohort Study." PLoS Neglected Tropical Diseases, vol. 11, no. 4, 2017, pp. e0005515.
Castro MDM, Cossio A, Velasco C, et al. 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;11(4):e0005515.
Castro, M. D. M., Cossio, A., Velasco, C., & Osorio, L. (2017). Risk factors for therapeutic failure to meglumine antimoniate and miltefosine in adults and children with cutaneous leishmaniasis in Colombia: A cohort study. PLoS Neglected Tropical Diseases, 11(4), e0005515. https://doi.org/10.1371/journal.pntd.0005515
Castro MDM, et al. 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;11(4):e0005515. PubMed PMID: 28379954.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Risk factors for therapeutic failure to meglumine antimoniate and miltefosine in adults and children with cutaneous leishmaniasis in Colombia: A cohort study. AU - Castro,Maria Del Mar, AU - Cossio,Alexandra, AU - Velasco,Carlos, AU - Osorio,Lyda, Y1 - 2017/04/05/ PY - 2016/12/16/received PY - 2017/03/21/accepted PY - 2017/04/17/revised PY - 2017/4/6/pubmed PY - 2017/5/17/medline PY - 2017/4/6/entrez SP - e0005515 EP - e0005515 JF - PLoS neglected tropical diseases JO - PLoS Negl Trop Dis VL - 11 IS - 4 N2 - INTRODUCTION: Reports 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. METHODS: A 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. RESULTS: Two 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). CONCLUSIONS: Clinical 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 REGISTRATION: Clinical trial registration: NCT00487253 Clinical trial registration: NCT01462500 Clinical trial registration: NCT01464242. SN - 1935-2735 UR - https://www.unboundmedicine.com/medline/citation/28379954/Risk_factors_for_therapeutic_failure_to_meglumine_antimoniate_and_miltefosine_in_adults_and_children_with_cutaneous_leishmaniasis_in_Colombia:_A_cohort_study_ L2 - https://dx.plos.org/10.1371/journal.pntd.0005515 DB - PRIME DP - Unbound Medicine ER -