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

NCT05562817 | Unknown

• 1 other identifier: RSV-Jo.Burden2022
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Syncytial Virus Infections

Keywords

Jordan; Epidemiology; Clinical burden; Economic burden

Outcome Measures

Primary Outcomes (1)

• to measure epidemiological burden of RSV infection in Jordan among hospitalized children under 5 years of age, proportion of RSV infections along with showing the data for the age 0-24 months and 25-59 months

  to measure the total epidemiological burden of RSV infection in Jordan among hospitalized children under 5 years of age, proportion of RSV infections along with showing the data for the age 0-24 months and 25-59 months separately.

  9 months

Secondary Outcomes (6)

• To measure the Odds ratio for risk factors of RSV infections

  9 months

• To measure selected clinical characteristics of RSV infections requiring hospital admissions and complications rates

  9 months

• To measure the proportion of RSV positivity amongst children hospitalized with acute respiratory infections.

  9 months

• To quantify the direct and indirect costs of RSV infections both at the community and hospital levels including readmissions, direct and indirect medical and societal costs:

  12 months

• To measure the distribution of RSV genotypes using representative national sample.

  6 months

Eligibility Criteria

• Age: 0 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Case definition: 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. outpatients and emergency department is of value, An additional sample of 200 children from emergency department and outpatients who meet above criteria will be also enrolled.

You may qualify if:

• A.-Patients age less than 5 years permanently resident in the study areas - hospitalized with acute respiratory infection according to below definition and criteria: hildren \<5 years of age admitted to study sites with
• At least one sign of acute infection (temperature ≥38 °C or \<35.5 °C, abnormal white blood cell \[WBC\] count or abnormal differential) and
• 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.
• outpatients and emergency department is of value,
• B-An additional sample of 200 children from emergency and outpatients clinics who meets above criteria.

You may not qualify if:

• A. Not permanently resident in Jordan.

Sponsors & Collaborators

• MENA Center for Research & Development and Internship: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Jordan University Hospital

Amman, Jordan

RECRUITING

Related Publications (2)

• Groothuis JR, Hoopes JM, Jessie VG. Prevention of serious respiratory syncytial virus-related illness. I: Disease pathogenesis and early attempts at prevention. Adv Ther. 2011 Feb;28(2):91-109. doi: 10.1007/s12325-010-0100-z. Epub 2011 Feb 4.

  PMID: 21318606 RESULT

• GBD 2016 Lower Respiratory Infections Collaborators. Estimates of the global, regional, and national morbidity, mortality, and aetiologies of lower respiratory infections in 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Infect Dis. 2018 Nov;18(11):1191-1210. doi: 10.1016/S1473-3099(18)30310-4. Epub 2018 Sep 19.

  PMID: 30243584 RESULT

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Financial Stress

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Dr Munir Abu-Helalah, MD

CONTACT

00962776981554; cmo@mena-rdi.org

Dr Mohamed Abu Lubbad, PhD

CONTACT

00962799105198; abu-lubbad@mena-rdi.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 3, 2022
• Study Start: November 20, 2022
• Primary Completion: June 30, 2023
• Study Completion: August 31, 2023
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)