Trial reportThe Journal of infectious diseases2012
Noninferiority of miltefosine versus meglumine antimoniate for cutaneous leishmaniasis in children.
Trial report in The Journal of infectious diseases, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00487253 (Randomized Clinical Trial of the Efficacy and Tolerability of Oral Miltefosine Versus Parenteral Antimony for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia), which is not on this map. Cited by 45 papers, 5 of them syntheses that pooled 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.
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.
Randomized Clinical Trial of the Efficacy and Tolerability of Oral Miltefosine Versus Parenteral Antimony for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia
Who cites it
45 citing papers in PubMed, 5 syntheses or guidelines pooled it, 101 citations in OpenAlex.
- Interventions for American cutaneous and mucocutaneous leishmaniasis.The Cochrane database of systematic reviews · 2020Pooled it
- Efficacy of miltefosine compared with glucantime for the treatment of cutaneous leishmaniasis: a systematic review and meta-analysis.Epidemiology and health · 2019Pooled it
- Interventions to treat cutaneous leishmaniasis in children: A systematic review.PLoS neglected tropical diseases · 2018Pooled it
- Species-directed therapy for leishmaniasis in returning travellers: a comprehensive guide.PLoS neglected tropical diseases · 2014Pooled it
- Interventions for American cutaneous and mucocutaneous leishmaniasis: a systematic review update.PloS one · 2013Pooled it
- Failure of fluconazole in treating cutaneous leishmaniasis caused by Leishmania guyanensis in the Brazilian Amazon: An open, nonrandomized phase 2 trial.PLoS neglected tropical diseases · 2018Trial
- Pharmacokinetics of Miltefosine in Children and Adults with Cutaneous Leishmaniasis.Antimicrobial agents and chemotherapy · 2017Trial
- Randomized single-blinded non-inferiority trial of 7 mg/kg pentamidine isethionate versus 4 mg/kg pentamidine isethionate for cutaneous leishmaniaisis in Suriname.PLoS neglected tropical diseases · 2015Trial
- Optimal dosing of miltefosine in children and adults with visceral leishmaniasis.Antimicrobial agents and chemotherapy · 2012Trial
- Dosing and safety of amphotericin B deoxycholate in paediatric American cutaneous leishmaniasis in Peru: a case series.BMC infectious diseases · 2025Article
- Response and therapeutic failure to meglumine antimoniate, the first-line drug for cutaneous leishmaniasis infections in Colombian soldiers.Parasitology research · 2025Article
- Off-label treatment with miltefosine for complex, pediatric Old World cutaneous leishmaniasis.JAAD case reports · 2025Article
- Effectiveness of Antileishmanial Treatments in Three Endemic Areas of Colombia: A Community-Based Cohort Study.The American journal of tropical medicine and hygiene · 2024Article
- Tolerability and Safety of Miltefosine for the Treatment of Cutaneous Leishmaniasis.Tropical medicine and infectious disease · 2024Article
- Natural resistance to meglumine antimoniate is associated with treatment failure in cutaneous leishmaniasis caused by Leishmania (Viannia) panamensis.PLoS neglected tropical diseases · 2024Article
- Characterisation of an area of coexistent visceral and cutaneous leishmaniasis transmission in the State of Piauí, Brazil.Memorias do Instituto Oswaldo Cruz · 2024Article
- Article
- Pentoxifylline in the Treatment of Cutaneous Leishmaniasis: A Randomized Clinical Trial in Colombia.Pathogens (Basel, Switzerland) · 2022Article
- Potency and Preclinical Evidence of Synergy of Oral Azole Drugs and Miltefosine in anAntimicrobial agents and chemotherapy · 2022Article
- Miltefosine for the treatment of cutaneous leishmaniasis-A pilot study from Ethiopia.PLoS neglected tropical diseases · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 5 institutions in 2 countries.
Funding
Abstract
backgroundChildren have a lower response rate to antimonial drugs and higher elimination rate of antimony (Sb) than adults. Oral miltefosine has not been evaluated for pediatric cutaneous leishmaniasis.
methodsA randomized, noninferiority clinical trial with masked evaluation was conducted at 3 locations in Colombia where Leishmania panamensis and Leishmania guyanensis predominated. One hundred sixteen children aged 2-12 years with parasitologically confirmed cutaneous leishmaniasis were randomized to directly observed treatment with meglumine antimoniate (20 mg Sb/kg/d for 20 days; intramuscular) (n = 58) or miltefosine (1.8-2.5 mg/kg/d for 28 days; by mouth) (n = 58). Primary outcome was treatment failure at or before week 26 after initiation of treatment. Miltefosine was noninferior if the proportion of treatment failures was ≤15% higher than achieved with meglumine antimoniate (1-sided test, α = .05).
resultsNinety-five percent of children (111/116) completed follow-up evaluation. By intention-to-treat analysis, failure rate was 17.2% (98% confidence interval [CI], 5.7%-28.7%) for miltefosine and 31% (98% CI, 16.9%-45.2%) for meglumine antimoniate. The difference between treatment groups was 13.8%, (98% CI, -4.5% to 32%) (P = .04). Adverse events were mild for both treatments.
conclusionsMiltefosine is noninferior to meglumine antimoniate for treatment of pediatric cutaneous leishmaniasis caused by Leishmania (Viannia) species. Advantages of oral administration and low toxicity favor use of miltefosine in children. CLINICAL
trial registrationNCT00487253.
Indexed as
Identifiers
What OpenQuestion holds
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.