Miniatura

Fitxers

Parrado_R_Antimicrob_Agents_Chemother_2019.pdf (2.16 MB)

Tipus de document

Article

Versió

Versió publicada

Data de publicació

2019

Llicència de publicació

cc by (c) American Society for Microbiology, 2019
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/132329

Usefulness of Serial Blood Sampling and PCR Replicates for Treatment Monitoring of Patients with Chronic Chagas Disease

Títol de la revista

Autors

Director/Tutor

ISSN de la revista

Títol del volum

Recurs relacionat

http://dx.doi.org/ 10.1128/AAC.01191-18

Resum

This work evaluated a serial blood sampling procedure to enhance the sensitivity of duplex real-time quantitative PCR (qPCR) for baseline detection and quantification of parasitic loads and posttreatment identification of failure in the context of clinical trials for treatment of chronic Chagas disease, namely, DNDi-CHE1224-001 (ClinicalTrials.gov registration no. NCT01489228) and the MSF-DNDi PCR Sampling Optimization Study (NCT01678599). Patients from Cochabamba (n 294), Tarija (n 257), and Aiquile (n 220) were enrolled. Three serial blood samples were collected at each time point, and qPCR triplicates were tested for each sample. The first two samples were collected during the same day and the third one 7 days later. A patient was considered PCR positive if at least one qPCR replicate was detectable. Cumulative results of multiple samples and qPCR replicates enhanced the proportion of pretreatment sample positivity from 54.8% to 76.2%, 59.5% to 77.8%, and 73.5% to 90.2% in Cochabamba, Tarija, and Aiquile cohorts, respectively. This strategy increased the detection of treatment failure from 72.9% to 91.7%, 77.8% to 88.9%, and 42.9% to 69.1% for E1224 low-, short-, and high-dosage regimens, respectively, and from 4.6% to 15.9% and 9.5% to 32.1% for the benznidazole arm in the DNDi-CH-E1224-001 and MSF-DNDi studies, respectively. The addition of the third blood sample and third qPCR replicate in patients with nondetectable PCR results in the first two samples gave a small, non-statistically significant improvement in qPCR positivity. No change in clinical sensitivity was seen with a blood volume increase from 5 to 10 ml. The monitoring of patients treated with placebo in the DNDi-CH-E1224-001 trial revealed fluctuations in parasitic loads and occasionally nondetectable results. In conclusion, a serial sampling strategy enhanced PCR sensitivity to detecting treatment failure during follow-up and has the potential for improving recruitment capacity in Chagas disease trials, which require an initial positive qPCR result for patient admission.

Matèries

Malaltia de Chagas, Assaigs clínics

Matèries (anglès)

Chagas' disease, Clinical trials

Citació

Col·leccions

Articles publicats en revistes (ISGlobal)

Citació

PARRADO, Rudy, RAMÍREZ, Juan carlos, BARRA, Anabelle de la, ALONSO-VEGA, Cristina, JUIZ, Natalia, ORTIZ, Lourdes, ILLANES, Daniel, TORRICO, Faustino, GASCÓN I BRUSTENGA, Joaquim, ALVES, Fabiana, FLEVAUD, Laurence, GARCÍA, Lineth, SCHIJMAN, Alejandro g., RIBEIRO, Isabela. Usefulness of Serial Blood Sampling and PCR Replicates for
Treatment Monitoring of Patients with Chronic Chagas
Disease. _Antimicrobial Agents and Chemotherapy_. 2019. Vol. 63, núm. 2, pàgs. e01191. [consulta: 24 de gener de 2026]. ISSN: 0066-4804. [Disponible a: https://hdl.handle.net/2445/132329]

Exportar metadades

JSON - METS

Compartir registre