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Nifurtimox versus benznidazole or placebo for asymptomatic Trypanosoma cruzi infection (Equivalence of Usual Interventions for Trypanosomiasis - EQUITY): Study protocol for a randomised controlled trial

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dc.creatorVillar, Juan Carlosspa
dc.creatorHerrera, Víctor Mauriciospa
dc.creatorPérez Carreño, Juan Guillermospa
dc.creatorVáquiro Herrera, Elianaspa
dc.creatorCastellanos Domínguez, Yeny Zulayspa
dc.creatorVásquez, Skarlet Marcellspa
dc.creatorCucunubá, Zulma Milenaspa
dc.creatorPrado, Nilda Gracielaspa
dc.creatorHernández, Yolandaspa
dc.date.accessioned2020-05-26T00:01:41Z
dc.date.available2020-05-26T00:01:41Z
dc.date.created2019spa
dc.description.abstractBackground: Either benznidazole (BZN) or nifurtimox (NFX) is recommended as equivalent to treat Trypanosoma cruzi infection. Nonetheless, supportive data from randomised trials is limited to individuals treated with BZN in southern cone countries of Latin America. Methods: The goal of this randomised, concealed, blind, parallel-group trial is to inform the trypanocidal efficacy and safety of NFX and its equivalence to BZN among individuals with T. cruzi positive serology (TC+). Eligible individuals are TC+, 20-65 years old, with no apparent symptoms/signs or uncontrolled risk factors for cardiomyopathy and at negligible risk of re-infection. Consenting individuals (adherent to a 10-day placebo run-in phase) receive a 120-day BID blinded treatment with NFX, BZN or matching placebo (2:2:1 ratio). The four active medication arms include (1) a randomly allocated sequence of 60-day, conventional-dose (60CD) regimes (BZN 300 mg/day or NFX 480 mg/day, ratio 1:1), followed or preceded by a 60-day placebo treatment, or (2) 120-day half-dose (120HD) regimes (BZN 150 mg/day or NFX 240 mg/day, ratio 1:1). The primary efficacy outcome is the proportion of participants testing positive at least once for up to three polymerase chain reaction (PCR) assays (1 + PCR) 12-18 months after randomisation. A composite safety outcome includes moderate to severe adverse reactions, consistent blood marker abnormalities or treatment abandons. The trial outside Colombia (expected to recruit at least 60% of participants) is pragmatic; it may be open-label and not include all treatment groups, but it must adhere to the randomisation and data administration system and guarantee a blinded efficacy outcome evaluation. Our main comparisons include NFX groups with placebo (for superiority), NFX versus BZN groups and 60CD versus 120HD groups (for non-inferiority) and testing for the agent-dose and group-region interactions. Assuming a 1 + PCR ? 75% in the placebo group, up to 25% among BZN-treated and an absolute difference of up to ? 25% with NFX to claim its trypanocidal effect, 60-80 participants per group (at least 300 from Colombia) are needed to test our hypotheses (80-90% power; one-sided alpha level 1%). Discussion: The EQUITY trial will inform the trypanocidal effect and equivalence of nitroderivative agents NFX and BZN, particularly outside southern cone countries. Its results may challenge current recommendations and inform choices for these agents. Trial registration: ClinicalTrials.gov, NCT02369978. Registered on 24 February 2015. © 2019 The Author(s).eng
dc.format.mimetypeapplication/pdf
dc.identifier.doihttps://doi.org/10.1186/s13063-019-3423-3
dc.identifier.issn17456215
dc.identifier.urihttps://repository.urosario.edu.co/handle/10336/23396
dc.language.isoengspa
dc.publisherBioMed Central Ltd.spa
dc.relation.citationIssueNo. 1
dc.relation.citationTitleTrials
dc.relation.citationVolumeVol. 20
dc.relation.ispartofTrials, ISSN:17456215, Vol.20, No.1 (2019)spa
dc.relation.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85069218361&doi=10.1186%2fs13063-019-3423-3&partnerID=40&md5=d205249109a0d3069676094ecc02a792spa
dc.rights.accesRightsinfo:eu-repo/semantics/openAccess
dc.rights.accesoAbierto (Texto Completo)spa
dc.source.instnameinstname:Universidad del Rosariospa
dc.source.reponamereponame:Repositorio Institucional EdocURspa
dc.subject.keywordBenznidazolespa
dc.subject.keywordNifurtimoxspa
dc.subject.keywordPlacebospa
dc.subject.keywordAntitrypanosomal agentspa
dc.subject.keywordBenznidazolespa
dc.subject.keywordNifurtimoxspa
dc.subject.keywordNitroimidazole derivativespa
dc.subject.keywordAdultspa
dc.subject.keywordAdverse outcomespa
dc.subject.keywordAgedspa
dc.subject.keywordArticlespa
dc.subject.keywordChagas diseasespa
dc.subject.keywordControlled studyspa
dc.subject.keywordDisease severityspa
dc.subject.keywordDrug efficacyspa
dc.subject.keywordDrug safetyspa
dc.subject.keywordDyspepsiaspa
dc.subject.keywordFemalespa
dc.subject.keywordHeadachespa
dc.subject.keywordHumanspa
dc.subject.keywordMajor clinical studyspa
dc.subject.keywordMalespa
dc.subject.keywordMedication compliancespa
dc.subject.keywordMulticenter studyspa
dc.subject.keywordNeuropathic painspa
dc.subject.keywordParesthesiaspa
dc.subject.keywordPolymerase chain reactionspa
dc.subject.keywordRandomized controlled trialspa
dc.subject.keywordSerologyspa
dc.subject.keywordSkin manifestationspa
dc.subject.keywordTherapy effectspa
dc.subject.keywordTreatment durationspa
dc.subject.keywordTreatment outcomespa
dc.subject.keywordTreatment refusalspa
dc.subject.keywordTrypanosomiasisspa
dc.subject.keywordAsymptomatic diseasespa
dc.subject.keywordChagas diseasespa
dc.subject.keywordColombiaspa
dc.subject.keywordDrug effectspa
dc.subject.keywordMiddle agedspa
dc.subject.keywordMulticenter study (topic)spa
dc.subject.keywordParasitologyspa
dc.subject.keywordPathogenicityspa
dc.subject.keywordRandomized controlled trial (topic)spa
dc.subject.keywordTherapeutic equivalencespa
dc.subject.keywordTime factorspa
dc.subject.keywordTrypanosoma cruzispa
dc.subject.keywordYoung adultspa
dc.subject.keywordAdultspa
dc.subject.keywordAgedspa
dc.subject.keywordAsymptomatic diseasesspa
dc.subject.keywordChagas diseasespa
dc.subject.keywordColombiaspa
dc.subject.keywordFemalespa
dc.subject.keywordHumansspa
dc.subject.keywordMalespa
dc.subject.keywordMiddle agedspa
dc.subject.keywordMulticenter studies as topicspa
dc.subject.keywordNifurtimoxspa
dc.subject.keywordNitroimidazolesspa
dc.subject.keywordRandomized controlled trials as topicspa
dc.subject.keywordTherapeutic equivalencyspa
dc.subject.keywordTime factorsspa
dc.subject.keywordTreatment outcomespa
dc.subject.keywordTrypanocidal agentsspa
dc.subject.keywordTrypanosoma cruzispa
dc.subject.keywordYoung adultspa
dc.subject.keywordBenznidazolespa
dc.subject.keywordChagas disesespa
dc.subject.keywordNifurtimoxspa
dc.subject.keywordRandomized controlled trialspa
dc.subject.keywordTrypanosoma cruzispa
dc.titleNifurtimox versus benznidazole or placebo for asymptomatic Trypanosoma cruzi infection (Equivalence of Usual Interventions for Trypanosomiasis - EQUITY): Study protocol for a randomised controlled trialspa
dc.typearticleeng
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersion
dc.type.spaArtículospa
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