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Development of a diagnostic kit for simultaneous and low-cost detection of viral and bacterial agents associated with Acute Respiratory Infections

Development of RT-qPCR-HRM for simultaneous detection and low cost of viral and bacterial agents associated to Acute Respiratory Infections

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-7n6n5sd
Enrollment
Unknown
Registered
2023-11-29
Start date
2020-09-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Infections

Interventions

This is a phase 2 clinical study, of the diagnostic case-control type, which will use a convenience sample and there will be no randomization. A minimum of 300 convenience case samples and a minimum o
The second phase will be to investigate the presence of pathogens in biological samples from patients from the IOC/Fiocruz NB-3 Platform
E05.337.275.500

Sponsors

Instituto Nacional de Controle de Qualidade em Saúde
Lead Sponsor
Instituto Nacional de Controle de Qualidade em Saúde
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Clinical samples from participants aged 18 years or over; of both genders; samples with complete information and registered in the Sistema de Ambiente laboratorial (GAL), containing clinical data of patients who were suspected of having COVID-19; samples considered positive for SARS-CoV-2 whose ct (cyclethreshold) is =40; samples negative for SARS-CoV-2, with ct (cyclethreshold) >40; acute samples less than 10 days after the onset of respiratory symptoms; samples properly stored at -80ºC; clinical samples from participants with confirmed clinical signs of infections

Exclusion criteria

Exclusion criteria: Participants whose clinical sample does not have sufficient volume to perform the investigational test (volume less than 100 µL); samples registered in the Laboratory Environment System (GAL) with incomplete information; samples stored in conditions unsuitable for the study

Design outcomes

Primary

MeasureTime frame
Development of a kit for diagnosing viruses and bacteria that cause Acute Respiratory Infections in patients hospitalized with suspected COVID-19—

Secondary

MeasureTime frame
Development of a qPCR-HRM protocol for detection of the main Sars-Cov-2 variants;Development of a method with the same sensitivity and specificity as the method currently used to diagnose COVID-19 at a lower cost;Development of a differential diagnostic method to separate viral and bacterial etiological agents, which enables more appropriate management and treatment for the patient, leading to a better prognosis—

Countries

Brazil

Contacts

Public ContactIvano Capasso

Fundação Oswaldo Cruz

ivano.defilippis@fiocruz.br+552138655288

Outcome results

None listed

Source: REBEC (via WHO ICTRP)