- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05562817
The Epidemiology , Health and Economic Burden of RSV Amongst Hospitalized Children Under 5 Years of Age in Jordan (RSV-JO)
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
Study Overview
Status
Conditions
Detailed 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
- 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.
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Dr Munir Abu-Helalah, MD
- Phone Number: 00962776981554
- Email: cmo@mena-rdi.org
Study Contact Backup
- Name: Dr Mohamed Abu Lubbad, PhD
- Phone Number: 00962799105198
- Email: abu-lubbad@mena-rdi.org
Study Locations
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-
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Amman, Jordan
- Recruiting
- Jordan University Hospital
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Contact:
- Dr Einas Zayadneh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
- 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, An additional sample of 200 children from emergency department and outpatients who meet above criteria will be also enrolled.
Description
Inclusion Criteria:
-
Inclusion criteria:
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.
Exclusion Criteria:
A. Not permanently resident in Jordan.
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Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 9 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.
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9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To measure the Odds ratio for risk factors of RSV infections
Time Frame: 9 months
|
To measure the odds ratio for risk factors for RSV infection: (Infants: especially premature infants or babies who are 6 months or younger, congenital heart disease, chronic respiratory disease such as cystic fibrosis, immune deficiency: primary or secondary to medical condition or treatment), neuromuscular disorders, such as muscular dystrophy)
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9 months
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To measure selected clinical characteristics of RSV infections requiring hospital admissions and complications rates
Time Frame: 9 months
|
To measure the rates of clinical characteristics of RSV infections requiring hospital admissions and complications rates: duration of hospitalization, reason for admission, hypoxia, ICU admissions, pneumonia, ventilation, respiratory failure, Otitis media perforate or not perforated, presence of secondary infections, readmission, mortality rate particularly amongst premature infants or immunocompromised patients.
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9 months
|
To measure the proportion of RSV positivity amongst children hospitalized with acute respiratory infections.
Time Frame: 9 months
|
To measure the proportion of RSV positivity amongst children hospitalized with acute respiratory infections.
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9 months
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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:
Time Frame: 12 months
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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:
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12 months
|
To measure the distribution of RSV genotypes using representative national sample.
Time Frame: 6 months
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To measure the distribution of RSV genotypes using representative national sample.
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6 months
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To measure the positivity rate for RSV, without genotyping, amongst a selected sample from emergency and outpatients clinics
Time Frame: 9 months
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To measure the positivity rate for RSV, without genotyping, amongst a selected sample from emergency and outpatients clinics at Princess Rahma Governmental Hospital in Irbid and Jordan University Hospital in Amman to measure the health and cost burden.
Follow up of these subjects for revisits or admissions will be performed
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9 months
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RSV-Jo.Burden2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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