Evidence map›Paper›PMID 39627222›Full record

Trial reportNature communications2024

Early assessment of antibodies decline in Chagas patients following treatment using a serological multiplex immunoassay.

Ursula Saade, Jasper de Boer, Ivan Scandale, Jaime Altcheh, Hans Pottel, Eric Chatelain, Maan Zrein

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Nature communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03378661 (Phase 2 Randomized, Multicenter, Safety and Efficacy Trial to Evaluate Different Oral Benznidazole Monotherapy and Benznidazole/E1224 Combination Regimens for the Treatment of Adult Patients With Chronic Indeterminate Chagas Disease), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT03378661 phase2unknown statusnot on this map

Phase 2 Randomized, Multicenter, Safety and Efficacy Trial to Evaluate Different Oral Benznidazole Monotherapy and Benznidazole/E1224 Combination Regimens for the Treatment of Adult Patients With Chronic Indeterminate Chagas Disease

TypeinterventionalSponsorDrugs for Neglected DiseasesRan2016 to 2018Enrolled210ConditionsChagas DiseaseArmsBenznidazole, E1224, E1224 Placebo, Benznidazole Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Vaccines against chronicExpert review of vaccines · 2026
    Review
  2. Article
  3. Article
  4. Article
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

7 authors.

Ursula SaadeInfYnity Biomarkers, Lyon, France.ORCID 0000-0002-2410-3245
Jasper de BoerDepartment of Public Health and Primary Care, KU Leuven Campus Kulak Kortrijk, Kortrijk, Belgium.
Ivan ScandaleDrugs for Neglected Diseases initiative (DNDi), Geneva, Switzerland.ORCID 0000-0003-4242-9289
Jaime AltchehParasitology Service, Hospital de Niños "Ricardo Gutierrez" and Instituto Multidisciplinario de Investigacion en Patologias Pediatricas (IMIPP)-CONICET-GCBA, Buenos Aires, Argentina.
Hans PottelDepartment of Public Health and Primary Care, KU Leuven Campus Kulak Kortrijk, Kortrijk, Belgium.
Eric ChatelainDrugs for Neglected Diseases initiative (DNDi), Geneva, Switzerland. echatelain@dndi.org.ORCID 0000-0002-3158-7743
Maan ZreinInfYnity Biomarkers, Lyon, France. mzrein@infynity-biomarkers.com.ORCID 0000-0002-3301-4252

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Chagas disease following infection with Trypanosoma cruzi is a major public health issue, with the disease spreading beyond endemic regions and becoming more global due to the migration of infected individuals. The currently available anti-parasitic drugs, nifurtimox and benznidazole, remain insufficiently evaluated for their efficacy in adult patients. A key challenge is the lack of markers for parasitological cure, which also precludes the development of new treatments. Consequently, there is a critical need for a practical method to assess drug performance within a short timeframe. In this retrospective analysis of the phase 2 randomized controlled BENDITA trial (ClinicalTrials.gov: NCT03378661), we report the potential of a serological multiplex method (MultiCruzi), combined with advanced statistical analytical methods, to measure the response to anti-parasitic treatment of adult Chagas patients. Applying this approach to serum samples from adult patients in the indeterminate chronic stage of Chagas disease, treated with different benznidazole regimens and combinations, we predict treatment efficacy after just 6 months of follow-up, in sharp contrast to data obtained with conventional and recombinant T. cruzi ELISA tests. The obtained results are also compared with the PCR data. We propose integrating MultiCruzi as a serological method endpoint in proof-of-concept clinical trials for Chagas disease.

Indexed as

Antibodies, ProtozoanChagas DiseaseNitroimidazolesTrypanocidal AgentsTrypanosoma cruziAdultEnzyme-Linked Immunosorbent AssayFemaleHumansImmunoassayMaleMiddle AgedNifurtimoxRetrospective StudiesTreatment OutcomeAntibodies, ProtozoanbenzonidazoleNifurtimoxNitroimidazolesTrypanocidal Agents

Identifiers

PMID39627222
PMCPMC11615370

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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.