The Epidemiology , Health and Economic Burden of RSV Amongst Hospitalized Children Under 5 Years of Age in Jordan — RSV-JO  

Respiratory Syncytial Virus Infections Clinical Trial

Official title: The Epidemiology , Health and Economic Burden of Respiratory Syncytial Virus Amongst Hospitalized Children Under 5 Years of Age in Jordan: National Multi-center Cross-sectional Study

Status Recruiting

Clinical Trial Summary

RSV has a global healthcare burden and vaccine in the main preventive measure. There are no recent published studies that have evaluated the burden of RSV infections in the Middle East in term of incidence at a national level, complication rates, mortality rates, hospitalizations, secondary infections, or the direct and indirect costs. Most studies have been limited to identifying genotypes or calculating the incidence in selected sites. In order to facilitate the introduction of an effective preventive measure for control of RSV infections, it is essential at a national and regional levels to assess the burden of disease, molecular epidemiology, and economic burden based on direct and indirect costs of RSV infections.

Clinical Trial Description

A Multi-center cross-sectional study. A total of 4 study centers will be included distributed in central, Northern and southern regions of Jordan as follows; 1. Princess Rahma Hospital for Children, Irbid, 2. Zarqa Hospital serving center and east of Jordan 3. Jordan University Hospital, Amman 4.Al Karak Public Hospital, Al Karak.

Case definition: 46 Diagnosis of acute respiratory infection: Defined as "an illness presenting with one or more of the following symptoms for less than 7 days: Fever, cough, earache, nasal congestion, rhinorrhea, sore throat, vomiting after coughing, Crackles, and labored, rapid or shallow breathing".

Study population:

Children <5 years of age admitted to study sites with

1. At least one sign of acute infection (temperature ≥38 °C or <35.5 °C, abnormal white blood cell [WBC] count or abnormal differential) and

2. At least 1 of the following respiratory signs or symptoms for less than 7 days:

tachypnea, cyanosis, cough, sputum production, pleuritic chest pain, hemoptysis, dyspnea, sore throat. cough, runny nose, grunting, wheeze, apnoea, difficulty in breathing.

The main sample of 1000 children will be from hospitalized children The focus on the hospitalized patients to assess the role of RSV infections in hospitalization, complications and economic burden.

An additional sample of 200 children from emergency department and a representative outpatients or healthcare center at sample from emergency and outpatients clinics at Princess Rahma Governmental Hospital in Irbid and Jordan University Hospital in Amman, to assess the proportion of RSV positivity and cost burden of the visit.

This will be conducted at sample from emergency and outpatients clinics at Princess Rahma Governmental Hospital in Irbid and Jordan University Hospital in Amman.

Sample collection and processing:

• Nasopharyngeal (NP) specimen will be collected from each patient, who meets inclusion criteria and consent for the study, using NP swab then Multiplex viral (RT)PCR will be performed on each Nasopharyngeal specimen testing

• PCR will be used to diagnosed cases with RSV at the included sites.

• RSV positive samples will be further analyzed for genotyping.

Packaging and shipment of clinical specimens Specimens for virus detection from nasopharyngeal and oropharyngeal will be collected using Dacron or polyester flocked swabs in a viral transport medium (VTM) containing antifungal and antibiotic supplements. Specimens will be transported to the laboratory as soon as possible after collection. Specimens that cannot be delivered promptly to the laboratory will be stored and shipped at 2-8°C for up to 3 days.. For the Bronchoalveolar lavage, the same as applied on the nasopharyngeal and oropharyngeal specimens except that the storage 2-8°C will be up to 2 days and at - 20°C or ideally -70°C and shipped on dry ice if further delays are expected for more than 2 days. 50,51

• Samples will be analyzed at central laboratory using the same kits throughout the study.

• Multiplex viral (RT)PCR will be performed on each Nasopharyngeal specimen testing for respiratory viruses, namely:

4 Viruses + RSV genotyping

• Flu A

• Flu B

• RSV-A

• RSV-B

• SARS-CoV-2

• Quality assurance measures will be performed throughout the study.

• Pharmacoeconomics data:The economic burden of RSV will be assessed. Applying societal perspective, all direct medical, direct non-medical and indirect costs will be quantified (collected). With micro-costing approach, multiplication of utilization of resource quantity and unit cost will be used. At first, all required resources to treat an episode of RSV cases will be identified, through including the quantity and/or frequency of medications, medical supplies, diagnostic tests, number of hospital bed days, ambulatory clinic visits, travel time and cost, work absence (hours or days absent) and/or productivity losses of caregivers, and informal care visits. ;

Related Conditions & MeSH terms

• Financial Stress
• Respiratory Syncytial Virus Infections

• NCT number: NCT05562817
• Study type: Observational
• Source: MENA Center for Research & Development and Internship
• Contact: Dr Munir Abu-Helalah, MD
• Phone: 00962776981554
• Email: cmo@mena-rdi.org
• Status: Recruiting
• Start date: November 20, 2022
• Completion date: August 31, 2023