Evidence map›Paper›PMID 32293523›Full record

ArticleTrials2020

Efficacy and safety assessment of different dosage of benznidazol for the treatment of Chagas disease in chronic phase in adults (MULTIBENZ study): study protocol for a multicenter randomized Phase II non-inferiority clinical trial.

D Molina-Morant, M L Fernández, P Bosch-Nicolau, E Sulleiro, M Bangher, F Salvador, A Sanchez-Montalva, A L P Ribeiro, A M B de Paula, S Eloi and 4 more

Erratum issued Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03191162 (Phase II Clinical Trial for the Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease in Adult Patients. Berenice Project), which is not on this map. Cited by 35 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 3 pooled it
4.7field-weighted citation impact, top 4% 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.

NCT03191162 phase2completednot on this map

Phase II Clinical Trial for the Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease in Adult Patients. Berenice Project

TypeinterventionalSponsorHospital Universitari Vall d'Hebron Research InstituteRan2017 to 2021Enrolled238ConditionsChagas Disease, Trypanosoma Cruzi InfectionArmsBenznidazole
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Trypanocidal Treatment for Chronic Chagas Disease: Past, Present, and Future.Revista da Sociedade Brasileira de Medicina Tropical · 2025
    Review
  10. Review
  11. Chagas disease in immunocompromised patients.Clinical microbiology reviews · 2024
    Review
  12. Article
  13. Nanomedicines against Chagas disease: a critical review.Beilstein journal of nanotechnology · 2024
    Review
  14. Observational
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 8 institutions in 6 countries.

D Molina-MorantInfectious Diseases Department, Vall d'Hebron University Hospital, PROSICS Barcelona, Universitat Autònoma de Barcelona, P° Vall d'Hebron 119, Edifici Mediterrània, VHIR, 08035, Barcelona, Spain.
M L FernándezDepartamento de Clínica, Patología y Tratamiento, Instituto Nacional de Parasitología Dr. Mario Fatala Chaben, Ministerio de Salud y Desarrollo Social, Buenos Aires, Argentina.
P Bosch-NicolauInfectious Diseases Department, Vall d'Hebron University Hospital, PROSICS Barcelona, Universitat Autònoma de Barcelona, P° Vall d'Hebron 119, Edifici Mediterrània, VHIR, 08035, Barcelona, Spain.
E SulleiroMicrobiology Department, Vall d'Hebron University Hospital, PROSICS Barcelona, Universitat Autònoma de Barcelona, Barcelona, Spain.
M BangherInstituto de Cardiología de Corrientes Juana Francisca Cabral (Argentina), Corrientes, Argentina.
F SalvadorInfectious Diseases Department, Vall d'Hebron University Hospital, PROSICS Barcelona, Universitat Autònoma de Barcelona, P° Vall d'Hebron 119, Edifici Mediterrània, VHIR, 08035, Barcelona, Spain.
A Sanchez-MontalvaInfectious Diseases Department, Vall d'Hebron University Hospital, PROSICS Barcelona, Universitat Autònoma de Barcelona, P° Vall d'Hebron 119, Edifici Mediterrània, VHIR, 08035, Barcelona, Spain.
A L P RibeiroPrograma de Pós-graduação Infectologia e Medicina Tropical, Faculdade de Medicina da Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.
A M B de PaulaLaboratory of Health Science, Postgraduate Program in Health Sciences, Universidade Estadual de Montes Claros (Unimontes), Montes Claros, MG, Brazil.
S EloiPrograma de Pós-graduação em Patologia, Departamento de Propedêutica Complementar, Faculdade de Medicina da Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.
R Correa-OliveiraRené Rachou Institute, Oswaldo Cruz Foundation, Belo Horizonte, Brazil.
J C VillarFaculty of Health Sciences, Universidad Autónoma de Bucaramanga and Research Department, Bucaramanga, Colombia.
S Sosa-EstaniChagas Clinical Program, Drugs for Neglected Disease initiative (DNDi), Geneva, Switzerland.
I MolinaInfectious Diseases Department, Vall d'Hebron University Hospital, PROSICS Barcelona, Universitat Autònoma de Barcelona, P° Vall d'Hebron 119, Edifici Mediterrània, VHIR, 08035, Barcelona, Spain. imolina@vhebron.net.ORCID http://orcid.org/0000-0001-6642-7515
Universitat Autònoma de Barcelona · ESUniversidade Federal de Minas Gerais · BRDrugs for Neglected Diseases Initiative · CHFundação Oswaldo Cruz · BRHebron University · PSMinisterio de Salud · ARUniversidad Autónoma de Bucaramanga · COUniversidade Estadual de Montes Claros · BR

Funding

FP7 Science in Society HEALTH-305937
6 · The paper itself

Abstract

backgroundChagas disease (CD) continues to be a neglected infectious disease with one of the largest burdens globally. Despite the modest cure rates in adult chronic patients and its safety profile, benznidazole (BNZ) is still the drug of choice. Its current recommended dose is based on nonrandomized studies, and efficacy and safety of the optimal dose of BNZ have been scarcely analyzed in clinical trials. METHODS/

designMULTIBENZ is a phase II, randomized, noninferiority, double-blind, multicenter international clinical trial. A total of 240 patients with Trypanosoma CD in the chronic phase will be recruited in four different countries (Argentina, Brazil, Colombia, and Spain). Patients will be randomized to receive BNZ 150 mg/day for 60 days, 400 mg/day for 15 days, or 300 mg/day for 60 days (comparator arm). The primary outcome is the efficacy of three different BNZ therapeutic schemes in terms of dose and duration. Efficacy will be assessed according to the proportion of patients with sustained parasitic load suppression in peripheral blood measured by polymerase chain reaction. The secondary outcomes are related to pharmacokinetics and drug tolerability. The follow-up will be 12 months from randomization to end of study participation. Recruitment was started in April 2018.

conclusionThis is a clinical trial conducted for the assessment of different dose schemes of BNZ compared with the standard treatment regimen for the treatment of CD in the chronic phase. MULTIBENZ may help to clarify which is the most adequate BNZ regimen in terms of efficacy and safety, predicated on sustained parasitic load suppression in peripheral blood.

trial registrationClinicalTrials.gov, NCT03191162. Registered on 19 June 2017.

Indexed as

Chagas DiseaseNeglected DiseasesNitroimidazolesTrypanocidal AgentsTrypanosoma cruziAdultAftercareArgentinaBrazilCase-Control StudiesChronic DiseaseClinical Trials, Phase II as TopicColombiaDouble-Blind MethodEquivalence Trials as TopicFemalebenzonidazoleNitroimidazolesTrypanocidal AgentsBenznidazoleChagas diseaseClinical trialMulticenter studyTherapeutic

Identifiers

PMID32293523
PMCPMC7158046
OpenAlexW3015536052

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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.