Respiratory Syncytial Virus InfectionsRSV-JONCT05562817
The Epidemiology , Health and Economic Burden of RSV Amongst Hospitalized Children Under 5 Years of Age in Jordan
An observational study of Respiratory Syncytial Virus Infections, run by MENA Center for Research & Development and Internship at 1 site in Jordan.
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… Read more about this study
- Who is it for?
- Ages 0 to 60 months
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- How many people
- 1,200 participants
- Where
- 1 siteJordan
- Study dates
- 20 Nov 2022to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 60 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- -
- 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.
Who cannot join
- Not permanently resident in Jordan.
- -
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
Jordan University Hospital
Amman
Dr Einas Zayadneh
About this study
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
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.
Read the 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.
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Jordan, Epidemiology, Clinical burden, Economic burden
- Medical subject headings
- Respiratory Syncytial Virus Infections, Financial Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (6)
To measure the Odds ratio for risk factors of RSV infections
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)
Measured: 9 months
To measure selected clinical characteristics of RSV infections requiring hospital admissions and complications rates
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.
Measured: 9 months
To measure the proportion of RSV positivity amongst children hospitalized with acute respiratory infections.
To measure the proportion of RSV positivity amongst children hospitalized with acute respiratory infections.
Measured: 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:
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:
Measured: 12 months
To measure the distribution of RSV genotypes using representative national sample.
To measure the distribution of RSV genotypes using representative national sample.
Measured: 6 months
To measure the positivity rate for RSV, without genotyping, amongst a selected sample from emergency and outpatients clinics
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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start20 Nov 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MENA Center for Research & Development and Internship
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Munir Abu-Helalah, MENA Center for Research & Development and Internship
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562817
- Sponsor's protocol ID
- RSV-Jo.Burden2022
- Acronym
- RSV-JO
- Status last verified
- Dec 2022
- First submitted
- 28 Sep 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21318606GBD 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.
PubMed 30243584
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05562817
- Acronym / sponsor ID
- RSV-JO / RSV-Jo.Burden2022
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Jordan, Epidemiology, Clinical burden, Economic burden
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- MENA Center for Research & Development and InternshipUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 0 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- -
- 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,
Key exclusion criteria (2 listed)
- Not permanently resident in Jordan.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
To measure the Odds ratio for risk factors of RSV infections
Time frame: 9 months
To measure selected clinical characteristics of RSV infections requiring hospital admissions and complications rates
Time frame: 9 months
To measure the proportion of RSV positivity amongst children hospitalized with acute respiratory infections.
Time frame: 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:
Time frame: 12 months
To measure the distribution of RSV genotypes using representative national sample.
Time frame: 6 months
To measure the positivity rate for RSV, without genotyping, amongst a selected sample from emergency and outpatients clinics
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Results publication: PubMed 21318606Groothuis 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.
- Results publication: PubMed 30243584GBD 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus Infections, run by MENA Center for Research & Development and Internship at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Munir Abu-Helalah, MD (00962776981554, cmo@mena-rdi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562817, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.