Evidence map›Paper›PMID 34277476›Full record

Trial reportFrontiers in cellular and infection microbiology2021

A Pilot Randomized Clinical Trial: Oral Miltefosine and Pentavalent Antimonials Associated With Pentoxifylline for the Treatment of American Tegumentary Leishmaniasis.

Sofia Sales Martins, Daniel Holanda Barroso, Bruna Côrtes Rodrigues, Jorgeth de Oliveira Carneiro da Motta, Gustavo Subtil Magalhães Freire, Ledice Inácia de Araújo Pereira, Patrícia Shu Kurisky, Ciro Martins Gomes, Raimunda Nonata Ribeiro Sampaio

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Frontiers in cellular and infection microbiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.6field-weighted citation impact, top 11% 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

6 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
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 3 institutions in 1 country.

Sofia Sales MartinsPós-Graduação de Ciências da Saúde da Faculdade de Ciências Saúde, Universidade de Brasília, Brasília, Brazil.
Daniel Holanda BarrosoHospital Universitário de Brasília, Universidade de Brasília, Brasília, Brazil.
Bruna Côrtes RodriguesHospital Universitário de Brasília, Universidade de Brasília, Brasília, Brazil.
Jorgeth de Oliveira Carneiro da MottaHospital Universitário de Brasília, Universidade de Brasília, Brasília, Brazil.
Gustavo Subtil Magalhães FreireHospital Universitário de Brasília, Universidade de Brasília, Brasília, Brazil.
Ledice Inácia de Araújo PereiraDepartamento de Doenças Infecciosas, Hospital de Doenças Tropicais Dr. Anuar Auad (HDT), Goiânia, Brazil.
Patrícia Shu KuriskyHospital Universitário de Brasília, Universidade de Brasília, Brasília, Brazil.
Ciro Martins GomesHospital Universitário de Brasília, Universidade de Brasília, Brasília, Brazil.
Raimunda Nonata Ribeiro SampaioPós-Graduação de Ciências da Saúde da Faculdade de Ciências Saúde, Universidade de Brasília, Brasília, Brazil.
Hospital Universitário de Brasília · BRUniversidade de Brasília · BRInstituto Nacional de Ciência e Tecnologia de Doenças Tropicais · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: American tegumentary leishmaniasis (ATL), which can present as either cutaneous (CL) or mucosal leishmaniasis (ML), is endemic in South America, and first-line antimonial treatments are known for their wide range of adverse effects (AEs). Growing reports of drug resistance increase the urgency of the need for better treatment options. The objective of this pilot clinical trial was to assess the efficacy of and AEs associated with the oral combination of miltefosine and pentoxifylline based on a Methods: A pilot, randomized, open-label clinical trial was performed. The experimental group (M+P) received 50 mg twice a day (BID) miltefosine and 400 mg three times a day (TID) pentoxifylline, and the control group (A+P) received 20 mg Sb+V/kg/day intravenously and 400 mg TID pentoxifylline. Patients with ML received treatment for 28 days, and patients with CL received treatment for 20 days. Results: Forty-three patients were included: 25 with ML and 18 with CL caused by Conclusion: In this pilot randomized clinical trial, M+P treatment and A+P treatment yielded similar cure rates, and the former was associated with a lower risk of AEs. Future studies with more patients and longer follow-up are recommended.

Indexed as

Antiprotozoal AgentsLeishmaniasis, CutaneousPentoxifyllineHumansPhosphorylcholinePilot ProjectsTreatment OutcomeUnited StatesAntiprotozoal AgentsmiltefosinePentoxifyllinePhosphorylcholineAmerican tegumentary leishmaniasiscutaneous leishmaniasismiltefosinemucosal leishmaniasispentavalent antimonialpentoxifyllinerandomized clinical trial

Identifiers

PMID34277476
PMCPMC8281031
OpenAlexW3187020522

What OpenQuestion holds

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Registered trials

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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.