Evidence map›Paper›PMID 21292895›Full record

Trial reportThe American journal of tropical medicine and hygiene2011

Randomized controlled clinical trial to access efficacy and safety of miltefosine in the treatment of cutaneous leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil.

Anette Chrusciak-Talhari, Reynaldo Dietze, Carolina Chrusciak Talhari, Roberto Moreira da Silva, Ellen Priscila Gadelha Yamashita, Gerson de Oliveira Penna, Paulo Roberto Lima Machado, Sinésio Talhari

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The American journal of tropical medicine and hygiene, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02193022 (A Study for Safety and Efficacy of Miltefosine for Treatment of Children and Adolescents With Post-Kala-azar Dermal Leishmaniasis), which is not on this map. Cited by 76 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
76citing papers in PubMed, 5 pooled it
13.5field-weighted citation impact, top 1% 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.

NCT02193022 phase3completednot on this mapstarted 2014, after this paper: background citation

A Study for Safety and Efficacy of Miltefosine for Treatment of Children and Adolescents With Post-Kala-azar Dermal Leishmaniasis (PKDL) in Bangladesh and Association of Serum Vitamin E and Exposure to Arsenic With PKDL

TypeinterventionalSponsorInternational Centre for Diarrhoeal Disease Research, BangladeshRan2014 to 2019Enrolled80ConditionsPost Kala Azar Dermal LeishmaniasisArmsMiltefosine
3 · Its place in the literature

Who cites it

76 citing papers in PubMed, 5 syntheses or guidelines pooled it, 169 citations in OpenAlex.

  1. Interventions for American cutaneous and mucocutaneous leishmaniasis.The Cochrane database of systematic reviews · 2020
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  15. [Cutaneous leishmaniasis. Diagnosis and therapy in northern Afghanistan].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2014
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16 more citing papers are in PubMed but not listed here.

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 1 institution in 1 country.

Anette Chrusciak-TalhariFundação de Medicina Tropical do Amazonas and Universidade Estadual do Amazonas, Manaus, AM, Brasil. anettetalhari@terra.com.br
Reynaldo Dietze
Carolina Chrusciak Talhari
Roberto Moreira da Silva
Ellen Priscila Gadelha Yamashita
Gerson de Oliveira Penna
Paulo Roberto Lima Machado
Sinésio Talhari
Fundação de Medicina Tropical · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Miltefosine has been used in the treatment of several new world cutaneous leishmaniasis (CL) species with variable efficacy. Our study is the first evidence on its clinical efficacy in Leishmania (Viannia) guyanensis. In this phase II/III randomized clinical trial, 90 CL patients were randomly allocated (2:1) to oral miltefosine (2.5 mg/kg/day/28 days) (N = 60) or parenteral antimony (15-20 mg/Sb/kg/day/20 days) (N = 30) according to age groups: 2-12 y/o and 13-65 y/o. Patients were human immunodeficiency virus (HIV) noninfected parasitological proven CL without previous treatment. Definitive cure was accessed at 6 months follow-up visit. No severe adverse events occurred. Vomiting was the most frequent adverse event (48.3%) followed by nausea (8.6%) and diarrhea (6.7%). Cure rates were 71.4% (95% confidence interval [CI] = 57.8-82.7) and 53.6% (95% CI = 33.9-72.5) (P = 0.05) for miltefosine and antimonial, respectively. There were no differences in cure rates between age groups within the same treatment arms. Miltefosine was safe and relatively well tolerated and cure rate was higher than antimony.

Indexed as

AdolescentAdultAgedAntiprotozoal AgentsBrazilChildChild, PreschoolFemaleHumansLeishmania guyanensisLeishmaniasis, MucocutaneousMaleMeglumineMeglumine AntimoniateMiddle AgedOrganometallic CompoundsAntiprotozoal AgentsMeglumineMeglumine AntimoniatemiltefosineOrganometallic CompoundsPhosphorylcholine

Identifiers

PMID21292895
PMCPMC3029178
OpenAlexW2106282299

What OpenQuestion holds

Textmetadata
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.