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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 0 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •A. Not permanently resident in Jordan.
结局指标
主要结局
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
时间窗: 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.
次要结局
- To measure the Odds ratio for risk factors of RSV infections(9 months)
- To measure the distribution of RSV genotypes using representative national sample.(6 months)
- To measure the positivity rate for RSV, without genotyping, amongst a selected sample from emergency and outpatients clinics(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 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)
研究者
Munir Abu-Helalah
Chief Medical Officer
MENA Center for Research & Development and Internship