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Clinical Trials/CTRI/2024/05/067907
CTRI/2024/05/067907
Not yet recruiting
Not Applicable

Determining the prevalence and molecular epidemiology of respiratory syncytial virus (RSV) in pediatric population at KMC, Manipal, Karnataka

Manipal Institute of Virology, Manipal Academy of Higher Education1 site in 1 country100 target enrollmentStarted: June 3, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Manipal Institute of Virology, Manipal Academy of Higher Education
Enrollment
100
Locations
1
Primary Endpoint
To determine disease prevalence and prevalent

Overview

Brief Summary

This study involves collecting 100 biological samples [Nasopharyngeal swab, throat swab, nasal swab in Viral Transport Medium (VTM)]. The study population includes symptomatic children under the age of five with Acute Respiratory Infection (ARI)/Severe Acute Respiratory Infection (SARI)/Lower Respiratory Tract Infection (LRTI) attending the Pediatric Department at KMC hospital, Manipal. With the samples collected, an extraction process will be carried out followed by the detection of RSV-specific RNA using real-time RT-PCR, semi-nested conventional PCR, Sanger Sequencing, and Phylogenetic analysis of the strains. All the procedures mentioned will be performed at the laboratory of the Manipal Institute of Virology with good laboratory practice following all biosafety protocols. The genotyping study of RSV will give information on the currently circulating genotypes, their prevalence, and distribution patterns in the selected study population during the study period. The data obtained from this study will be informative for better diagnostic approaches and future surveillance of RSV. These findings will contribute to our understanding of the burden of RSV infection in this population.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
1.00 Day(s) to 5.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Symptomatic children below 5 years with an acute respiratory infection (ARI), severe acute respiratory infection (SARI), or lower respiratory infection (LRTI), admitted to the pediatric department at Kasturba Hospital.

Exclusion Criteria

  • Patients above 5 years of age and patients with non-consenting parents or guardians.

Outcomes

Primary Outcomes

To determine disease prevalence and prevalent

Time Frame: at hospital admission.

genotype of Respiratory Syncytial virus (RSV) circulating in Manipal, Karnataka.

Time Frame: at hospital admission.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Manipal Institute of Virology, Manipal Academy of Higher Education
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Chiranjay Mukhopadhyay

Manipal Institute of Virology

Study Sites (1)

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