Evidence map›Paper›PMID 40384408›Full record

Trial reportTropical medicine & international health : TM & IH2025

Cutaneous reactions during treatment with Nifurtimox or Benznidazole among Trypanosoma cruzi seropositive adults without symptomatic cardiomyopathy: A safety sub analysis of a placebo-controlled randomised trial.

Juan Carlos Villar, María Fernanda Saavedra, Pablo Andrés Bermúdez, Eliana Váquiro Herrera, Skarlet Marcell Vásquez, Helena Arango, Antonia Camacho, Mario Javier Olivera

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Tropical medicine & international health : TM & IH, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02369978 (Cardiovascular Health Investigation and Collaboration From Countries of America to Assess the Markers and Outcomes of Chagas Disease), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT02369978 phase2 / phase3unknown statusnot on this map

Cardiovascular Health Investigation and Collaboration From Countries of America to Assess the Markers and Outcomes of Chagas Disease (CHICAMOCHA-3) - EQUITY (Equivalence of Usual Interventions for Trypanosomiasis)

TypeinterventionalSponsorUniversidad Autónoma de BucaramangaRan2015 to 2019Enrolled500ConditionsChagas DiseaseArmsNifurtimox, Benznidazole, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Trypanocidal Treatment for Chronic Chagas Disease: Past, Present, and Future.Revista da Sociedade Brasileira de Medicina Tropical · 2025
    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

8 authors.

Juan Carlos VillarFacultad de Ciencias de la Salud, Universidad Autónoma de Bucaramanga, Bucaramanga, Colombia.
María Fernanda SaavedraCentro de Investigaciones, Fundación Cardioinfantil-Instituto de Cardiología, Bogotá, Colombia.ORCID https://orcid.org/0000-0003-1191-4361
Pablo Andrés BermúdezCentro de Investigaciones, Fundación Cardioinfantil-Instituto de Cardiología, Bogotá, Colombia.ORCID https://orcid.org/0000-0002-6008-5785
Eliana Váquiro HerreraCentro de Investigaciones, Fundación Cardioinfantil-Instituto de Cardiología, Bogotá, Colombia.ORCID https://orcid.org/0000-0001-6030-8128
Skarlet Marcell VásquezFacultad de Ciencias de la Salud, Universidad Autónoma de Bucaramanga, Bucaramanga, Colombia.ORCID https://orcid.org/0000-0003-2552-9819
Helena ArangoCentro de Investigaciones, Fundación Cardioinfantil-Instituto de Cardiología, Bogotá, Colombia.ORCID https://orcid.org/0009-0004-1807-1867
Antonia CamachoCentro de Investigaciones, Fundación Cardioinfantil-Instituto de Cardiología, Bogotá, Colombia.ORCID https://orcid.org/0009-0007-0318-8263
Mario Javier OliveraGrupo de Parasitología, Instituto Nacional de Salud, Bogotá, Colombia.

Funding

"Ministerio de Ciencia, Tecnología e Innovación" of Colombia 729-2013
6 · The paper itself

Abstract

objectivesTo determine, in a randomised placebo-controlled trial, if cutaneous adverse reactions during treatment (CARDT) with Benznidazole occur as often as with Nifurtimox, and whether the dose and duration of treatment change that frequency.

methodsWe conducted the EQUITY trial (NCT02369978), allocating Trypanosoma cruzi seropositive adults with no apparent clinical disease to a 120-day, blinded treatment with Benznidazole, Nifurtimox, or Placebo (ratio 2:2:1). Active treatment groups included either 60-day conventional-dose (60CD) regimens (Benznidazole 300 mg/day or Nifurtimox 480 mg/day, followed or preceded by, 60 days of placebo) or 120-day half-dose (120HD) regimens (Benznidazole 150 mg/day or Nifurtimox 240 mg/day). CARDT had blinded adjudication as moderate to severe during the follow-up visits.

resultsAmong 307 participants, 42 CARDT (17.1%, 95% confidence interval [CI] 12.6-22.4) occurred in 246 receiving active treatment, compared to two CARDT (3.3%, 95% CI 0.0-11.3) in 61 participants receiving placebo. In 122 patients treated with Benznidazole, there were 31 CARDT (25.4%, including eight severe), compared to 11 CARDT (8.9%, including four severe) in 124 individuals treated with Nifurtimox (p < 0.001). Among the 125 participants assigned to the 120HD regimen, there were 26 CARDT (20.8%, including six severe), compared to 16 CARDT (13.2%, including six severe) among 121 in the 60CD group (p = 0.005). The agent-regime interaction was not significant (p = 0.443). Eleven participants (25%) with CARDT did not complete their treatment.

conclusionCARDT occurred more frequently with Benznidazole treatment, particularly with longer exposure despite the half-dose regimen. Clinicians should consider these differences when discussing treatment options with patients receiving nitro derivative agents.

Indexed as

Chagas DiseaseDrug EruptionsNifurtimoxNitroimidazolesTrypanocidal AgentsTrypanosoma cruziAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedbenzonidazoleNifurtimoxNitroimidazolesTrypanocidal AgentsBenznidazoleChagas diseasedrug eruptionsdrug related side effects and adverse reactionsNifurtimoxrandomised controlled trials as topicTrypanosoma cruzi infections

Identifiers

PMID40384408
PMCPMC12213319

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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.