Trial reportPLoS neglected tropical diseases2017
Efficacy and safety of available treatments for visceral leishmaniasis in Brazil: A multicenter, randomized, open label trial.
Trial report 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 trial NCT01310738 (Multicentric Efficacy and Safety Study of Antileishmanial Drugs for Treatment of Visceral Leishmaniasis in Brazil), which is not on this map. Cited by 24 papers, 1 of them a synthesis 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.
Multicentric Efficacy and Safety Study of Antileishmanial Drugs for Treatment of Visceral Leishmaniasis in Brazil
Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 72 citations in OpenAlex.
- Global Landscape of Molecular and Immunological Diagnostic Tests for Human Leishmaniasis: A Systematic Review and Meta-Analysis.Pathogens (Basel, Switzerland) · 2025Pooled it
- Multiscale-Aware Graph Embedding Approach Uncovers LC-61, a Potent Anti-Journal of chemical information and modeling · 2026Article
- New Copper (II) Complexes Based on 1,4-Disubstituted-1,2,3-Triazole Ligands with Promising Antileishmanial Activity.Pharmaceutics · 2026Article
- Evidence Gaps and Global Patterns in Leishmaniasis Control: A Scoping Review of Clinical, Diagnostic, and Treatment Strategies.Journal of parasitology research · 2026Review
- Leishmaniasis.Nature reviews. Disease primers · 2025Review
- Epidemiological insights and clinical management of paediatric kala-azar in Shanxi Province (2014-2023): retrospective analysis of case characteristics and therapeutic strategies.BMJ paediatrics open · 2025Article
- Factors associated with survival in patients with visceral leishmaniasis treated at a reference hospital in northern Minas Gerais - Brazil.Revista da Sociedade Brasileira de Medicina Tropical · 2024Article
- Article
- Recent Advances in Chemotherapeutics for Leishmaniasis: Importance of the Cellular Biochemistry of the Parasite and Its Molecular Interaction with the Host.Pathogens (Basel, Switzerland) · 2023Review
- Visceral Leishmaniasis: Epidemiology, Diagnosis, and Treatment Regimens in Different Geographical Areas with a Focus on Pediatrics.Microorganisms · 2022Review
- Current leishmaniasis drug discovery.RSC medicinal chemistry · 2022Review
- In Vitro Susceptibility to Miltefosine ofMicroorganisms · 2021Article
- Hemophagocytic lymphohistiocytosis and visceral leishmaniasis in children: a series of cases and literature review.Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo · 2021Review
- Multifunctional, TNF-α and IFN-γ-Secreting CD4 and CD8 T Cells and CD8Frontiers in immunology · 2021Article
- Is splenectomy an option for multiple relapses in a child with visceral leishmaniasis? A case report.Revista da Sociedade Brasileira de Medicina Tropical · 2021Article
- Genetic validation of Leishmania genes essential for amastigote survival in vivo using N-myristoyltransferase as a model.Parasites & vectors · 2020Article
- Premature deaths by visceral leishmaniasis in Brazil investigated through a cohort study: A challenging opportunity?PLoS neglected tropical diseases · 2019Article
- Liposomal Amphotericin B Treatment and the Leishmaniases.The American journal of tropical medicine and hygiene · 2019Article
- Susceptibility testing of Leishmania spp. against amphotericin B and fluconazole using the Sensititre™ YeastOne™ YO9 platform.BMC infectious diseases · 2019Article
- Clinical Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of Liposomal Amphotericin B.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 8 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere is insufficient evidence to support visceral leishmaniasis (VL) treatment recommendations in Brazil and an urgent need to improve current treatments. Drug combinations may be an option.
methodsA multicenter, randomized, open label, controlled trial was conducted in five sites in Brazil to evaluate efficacy and safety of (i) amphotericin B deoxycholate (AmphoB) (1 mg/kg/day for 14 days), (ii) liposomal amphotericin B (LAMB) (3 mg/kg/day for 7 days) and (iii) a combination of LAMB (10 mg/kg single dose) plus meglumine antimoniate (MA) (20 mg Sb+5/kg/day for 10 days), compared to (iv) standard treatment with MA (20 mg Sb+5/kg/day for 20 days). Patients, aged 6 months to 50 years, with confirmed VL and without HIV infection were enrolled in the study. Primary efficacy endpoint was clinical cure at 6 months. A planned efficacy and safety interim analysis led to trial interruption.
results378 patients were randomized to the four treatment arms: MA (n = 112), AmphoB (n = 45), LAMB (n = 109), or LAMB plus MA (n = 112). A high toxicity of AmphoB prompted an unplanned interim safety analysis and this treatment arm was dropped. Per intention-to-treat protocol final analyses of the remaining 332 patients show cure rates at 6 months of 77.5% for MA, 87.2% for LAMB, and 83.9% for LAMB plus MA, without statistically significant differences between the experimental arms and comparator (LAMB: 9.7%; CI95% -0.28 to 19.68, p = 0.06; LAMB plus MA: 6.4%; CI95% -3.93 to 16.73; p = 0.222). LAMB monotherapy was safer than MA regarding frequency of treatment-related adverse events (AE) (p = 0.045), proportion of patients presenting at least one severe AE (p = 0.029), and the proportion of AEs resulting in definitive treatment discontinuation (p = 0.003).
conclusionsDue to lower toxicity and acceptable efficacy, LAMB would be a more suitable first line treatment for VL than standard treatment. ClinicalTrials.gov identification number: NCT01310738.
trial registrationClinicalTrials.gov NCT01310738.
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.