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dc.contributor.author
Maguire, Brittany J.  
dc.contributor.author
Dahal, Prabin  
dc.contributor.author
Rashan, Sumayyah  
dc.contributor.author
Ngu, Roland  
dc.contributor.author
Boon, Anca  
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Forsyth, Colin  
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Strub Wourgraft, Nathalie  
dc.contributor.author
Chatelain, Eric  
dc.contributor.author
Barreira, Fabiana  
dc.contributor.author
Sosa-Estani, Sergio Alejandro  
dc.contributor.author
Guerin, Philippe J.  
dc.date.available
2022-10-28T17:50:13Z  
dc.date.issued
2021-08  
dc.identifier.citation
Maguire, Brittany J.; Dahal, Prabin; Rashan, Sumayyah; Ngu, Roland; Boon, Anca; et al.; The chagas disease study landscape: A systematic review of clinical and observational antiparasitic treatment studies to assess the potential for establishing an individual participant-level data platform; Public Library of Science; PLoS Neglected Tropical Diseases; 15; 8; 8-2021; 1-20  
dc.identifier.issn
1935-2727  
dc.identifier.uri
http://hdl.handle.net/11336/175418  
dc.description.abstract
Background: Chagas disease (CD), caused by the parasite Trypanosoma cruzi, affects ~6–7 million people worldwide. Significant limitations still exist in our understanding of CD. Harnessing individual participant data (IPD) from studies could support more in-depth analyses to address the many outstanding research questions. This systematic review aims to describe the characteristics and treatment practices of clinical studies in CD and assess the breadth and availability of research data for the potential establishment of a data-sharing platform. Methodology/Principal findings This review includes prospective CD clinical studies published after 1997 with patients receiving a trypanocidal treatment. The following electronic databases and clinical trial registry platforms were searched: Cochrane Library, PubMed, Embase, LILACS, Scielo, Clintrials. gov, and WHO ICTRP. Of the 11,966 unique citations screened, 109 (0.9%) studies (31 observational and 78 interventional) representing 23,116 patients were included. Diagnosis for patient enrolment required 1 positive test result in 5 (4.6%) studies (2 used molecular method, 1 used molecular and serology, 2 used serology and parasitological methods), 2 in 60 (55.0%), 3 in 14 (12.8%) and 4 or more in 4 (3.7%) studies. A description of treatment regimen was available for 19,199 (83.1%) patients, of whom 14,605 (76.1%) received an active treatment and 4,594 (23.9%) were assigned to a placebo/no-treatment. Of the 14,605 patients who received an active treatment, benznidazole was administered in 12,467 (85.4%), nifurtimox in 825 (5.6%), itraconazole in 284 (1.9%), allopurinol in 251(1.7%) and other drugs in 286 (1.9%). Assessment of efficacy varied largely and was based primarily on biological outcome; parasitological efficacy relied on serology in 67/85 (78.8%) studies, molecular methods in 52/85 (61.2%), parasitological in 34/85 (40.0%), microscopy in 3/85 (3.5%) and immunohistochemistry in 1/85 (1.2%). The median time at which parasitological assessment was carried out was 79 days [interquartile range (IQR): 30–180] for the first assessment, 180 days [IQR: 60–500] for second, and 270 days [IQR: 18–545] for the third assessment. Conclusions/Significance This review demonstrates the heterogeneity of clinical practice in CD treatment and in the conduct of clinical studies. The sheer volume of potential IPD identified demonstrates the potential for development of an IPD platform for CD and that such efforts would enable indepth analyses to optimise the limited pharmacopoeia of CD and inform prospective data collection.  
dc.format
application/pdf  
dc.language.iso
eng  
dc.publisher
Public Library of Science  
dc.rights
info:eu-repo/semantics/openAccess  
dc.rights.uri
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/  
dc.subject
Chagas  
dc.subject
Systematic Review  
dc.subject
Data Sahering  
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Tropical disease  
dc.subject.classification
Enfermedades Infecciosas  
dc.subject.classification
Ciencias de la Salud  
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CIENCIAS MÉDICAS Y DE LA SALUD  
dc.title
The chagas disease study landscape: A systematic review of clinical and observational antiparasitic treatment studies to assess the potential for establishing an individual participant-level data platform  
dc.type
info:eu-repo/semantics/article  
dc.type
info:ar-repo/semantics/artículo  
dc.type
info:eu-repo/semantics/publishedVersion  
dc.date.updated
2022-09-29T13:47:08Z  
dc.identifier.eissn
1935-2735  
dc.journal.volume
15  
dc.journal.number
8  
dc.journal.pagination
1-20  
dc.journal.pais
Estados Unidos  
dc.description.fil
Fil: Maguire, Brittany J.. University of Oxford; Reino Unido  
dc.description.fil
Fil: Dahal, Prabin. University of Oxford; Reino Unido  
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Fil: Rashan, Sumayyah. University of Oxford; Reino Unido  
dc.description.fil
Fil: Ngu, Roland. University of Oxford; Reino Unido  
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Fil: Boon, Anca. University of Oxford; Reino Unido  
dc.description.fil
Fil: Forsyth, Colin. No especifíca;  
dc.description.fil
Fil: Strub Wourgraft, Nathalie. No especifíca;  
dc.description.fil
Fil: Chatelain, Eric. No especifíca;  
dc.description.fil
Fil: Barreira, Fabiana. No especifíca;  
dc.description.fil
Fil: Sosa-Estani, Sergio Alejandro. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina  
dc.description.fil
Fil: Guerin, Philippe J.. University of Oxford; Reino Unido  
dc.journal.title
PLoS Neglected Tropical Diseases  
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.1371/journal.pntd.0009697