Evidence map›Paper›PMID 29947651›Full record

Trial reportMemorias do Instituto Oswaldo Cruz2018

Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial.

Dario Brock Ramalho, Rosiana Estéfane da Silva, Maria Camilo Ribeiro de Senna, Hugo Silva Assis Moreira, Mariana Junqueira Pedras, Daniel Moreira de Avelar, Lara Saraiva, Ana Rabello, Gláucia Cota

Open access · diamondAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Memorias do Instituto Oswaldo Cruz, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
2.8field-weighted citation impact, top 10% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
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  3. Trial
  4. Observational
  5. Review
  6. Article
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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

9 authors at 2 institutions in 1 country.

Dario Brock RamalhoFundação Hospitalar do Estado de Minas Gerais, Hospital Eduardo de Menezes, Belo Horizonte, MG, Brasil.
Rosiana Estéfane da SilvaFundação Oswaldo Cruz, Instituto René Rachou, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias, Belo Horizonte, MG, Brasil.
Maria Camilo Ribeiro de SennaFundação Oswaldo Cruz, Instituto René Rachou, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias, Belo Horizonte, MG, Brasil.
Hugo Silva Assis MoreiraFundação Oswaldo Cruz, Instituto René Rachou, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias, Belo Horizonte, MG, Brasil.
Mariana Junqueira PedrasFundação Oswaldo Cruz, Instituto René Rachou, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias, Belo Horizonte, MG, Brasil.
Daniel Moreira de AvelarFundação Oswaldo Cruz, Instituto René Rachou, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias, Belo Horizonte, MG, Brasil.
Lara SaraivaFundação Oswaldo Cruz, Instituto René Rachou, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias, Belo Horizonte, MG, Brasil.
Ana RabelloFundação Oswaldo Cruz, Instituto René Rachou, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias, Belo Horizonte, MG, Brasil.
Gláucia CotaFundação Oswaldo Cruz, Instituto René Rachou, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias, Belo Horizonte, MG, Brasil.
Fundação Oswaldo Cruz · BRFundação Hospitalar do Estado de Minas Gerais · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCutaneous leishmaniasis (CL) is a world-wide health problem which currently lacks effective, affordable and easy to use therapy. Recently, the meglumine antimoniate (MA) intralesional infiltration was included among the acceptable therapies for New World leishmaniasis. While this approach is attractive, there is currently little evidence to support its use in Americas.

objectivesThe aim of this study was to provide information about effectiveness and safety of a standardised MA intralesional infiltration technique for the treatment of CL.

methodsIt is a single-arm phase II clinical trial conducted at a Brazilian referral centre. CL cases with parasitological confirmation presenting a maximum of three CL-compatible skin lesions were treated with weekly MA intralesional infiltration by using a validated technique, up to a maximum of eight infiltrations.

resultsA total of 53 patients (62 lesions) were included. Overall, patients received a median of seven infiltrations (IQR25-75% 5-8) over a median treatment period of 43 days (IQR25-75% 28-52 days). The definitive cure rate at D180 was 87% (95% CI:77-96%). The majority of adverse events were local, with mild or moderate intensity. Bacterial secondary infection of the lesion site was observed in 13% of the treated patients, beside two intensity-three adverse events (hypersensitivity reactions).

Indexed as

AdolescentAdultAgedAntiprotozoal AgentsBrazilFemaleHumansInjections, IntralesionalLeishmaniasis, CutaneousMaleMeglumineMeglumine AntimoniateMiddle AgedOrganometallic CompoundsTreatment OutcomeYoung AdultAntiprotozoal AgentsMeglumineMeglumine AntimoniateOrganometallic Compounds

Identifiers

PMID29947651
PMCPMC6012678
OpenAlexW2810115595

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.