ArticlePloS one2017
First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease.
Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 21 papers.
What it found
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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.
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.
Protocol for phase ii clinical trial, randomized and open for etiological treatment of chronic chagas disease with posaconazole and benznidazole
Phase 2 Randomized, Multicenter, Placebo-controlled, Safety and Efficacy Study to Evaluate Three Oral E1224 Dosing Regimens and Benznidazole for the Treatment of Adult Patients With Chronic Indeterminate Chagas Disease
Optimization of Sampling Procedure for PCR Technique to Assess Parasitological Response for Patients With Chronic Chagas Disease Treated With Benznidazole in Aiquile, Bolivia
Who cites it
21 citing papers in PubMed, 31 citations in OpenAlex.
- Usefulness of Serial Blood Sampling and PCR Replicates for Treatment Monitoring of Patients with Chronic Chagas Disease.Antimicrobial agents and chemotherapy · 2019Trial
- Consensus framework for developing a target product profile of real-time PCR in Chagas disease therapeutic monitoring.PLoS neglected tropical diseases · 2026Article
- Retrospect, advances and challenges in Chagas disease diagnosis: a comprehensive review.Lancet regional health. Americas · 2024Review
- Parasite Burden ofMicroorganisms · 2024Article
- Congenital Transmission ofVector borne and zoonotic diseases (Larchmont, N.Y.) · 2023Article
- Article
- Biomarkers and Echocardiographic Predictors of Cardiovascular Outcome in Patients With Chronic Chagas Disease.Journal of the American Heart Association · 2023Observational
- Chagas Disease.Annals of internal medicine · 2023Review
- Predictors of Trypanosoma cruzi PCR positivity in patients with chronic Chagas disease.Memorias do Instituto Oswaldo Cruz · 2023Observational
- Unveiling challenges in real-time PCR strategies for detecting treatment failure: observations from clinical trials on chronic Chagas disease.Frontiers in parasitology · 2023Review
- Identification of the parasite, Trypanosoma cruzi, in multiple tissues of epidemiological significance in the Virginia opossum (Didelphis virginiana): Implications for environmental and vertical transmission routes.PLoS neglected tropical diseases · 2022Article
- Results and evaluation of the expansion of a model of comprehensive care for Chagas disease within the National Health System: The Bolivian Chagas network.PLoS neglected tropical diseases · 2022Article
- Prospective multicenter evaluation of real time PCR Kit prototype for early diagnosis of congenital Chagas disease.EBioMedicine · 2021Article
- Application of WHO International Biological Reference Standards to evaluate commercial serological tests for chronic Chagas disease.Memorias do Instituto Oswaldo Cruz · 2020Article
- Chagas Disease in the United States: a Public Health Approach.Clinical microbiology reviews · 2019Review
- Congenital Chagas disease: Updated recommendations for prevention, diagnosis, treatment, and follow-up of newborns and siblings, girls, women of childbearing age, and pregnant women.PLoS neglected tropical diseases · 2019Article
- Trypomastigote Excretory Secretory Antigen Blot Is Associated With Trypanosoma cruzi Load and Detects Congenital T. cruzi Infection in Neonates, Using Anti-Shed Acute Phase Antigen Immunoglobulin M.The Journal of infectious diseases · 2019Article
- Improved DNA extraction technique from clot for the diagnosis of Chagas disease.PLoS neglected tropical diseases · 2019Article
- Exploring the parasite load and molecular diversity of Trypanosoma cruzi in patients with chronic Chagas disease from different regions of Brazil.PLoS neglected tropical diseases · 2018Observational
- Monitoring the parasite load in chronic Chagas disease patients: comparison between blood culture and quantitative real time PCR.PloS one · 2018Article
Corrections and comments
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Authors and funding
18 authors at 9 institutions in 4 countries.
Funding
Abstract
Real-Time PCR (qPCR) testing is recommended as both a diagnostic and outcome measurement of etiological treatment in clinical practice and clinical trials of Chagas disease (CD), but no external quality assurance (EQA) program provides performance assessment of the assays in use. We implemented an EQA system to evaluate the performance of molecular biology laboratories involved in qPCR based follow-up in clinical trials of CD. An EQA program was devised for three clinical trials of CD: the E1224 (NCT01489228), a pro-drug of ravuconazole; the Sampling Study (NCT01678599), that used benznidazole, both conducted in Bolivia; and the CHAGASAZOL (NCT01162967), that tested posaconazole, conducted in Spain. Four proficiency testing panels containing negative controls and seronegative blood samples spiked with 1, 10 and 100 parasite equivalents (par. eq.)/mL of four Trypanosoma cruzi stocks, were sent from the Core Lab in Argentina to the participating laboratories located in Bolivia and Spain. Panels were analyzed simultaneously, blinded to sample allocation, at 4-month intervals. In addition, 302 random blood samples from both trials carried out in Bolivia were sent to Core Lab for retesting analysis. The analysis of proficiency testing panels gave 100% of accordance (within laboratory agreement) and concordance (between laboratory agreement) for all T. cruzi stocks at 100 par. eq./mL; whereas their values ranged from 71 to 100% and from 62 to 100% at 1 and 10 par. eq./mL, respectively, depending on the T. cruzi stock. The results obtained after twelve months of preparation confirmed the stability of blood samples in guanidine-EDTA buffer. No significant differences were found between qPCR results from Bolivian laboratory and Core Lab for retested clinical samples. This EQA program for qPCR analysis of CD patient samples may significantly contribute to ensuring the quality of laboratory data generated in clinical trials and molecular diagnostics laboratories of CD.
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What OpenQuestion holds
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.