Prevention of Secondary Transmission of Human Influenza by Promoting Handwashing With Soap: The Bangladesh Interruption of Secondary Transmission of Influenza Study (BISTIS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6,600
- 试验地点
- 1
- 主要终点
- To test the efficacy of a handwashing promotion intervention for prevention of intrahousehold transmission of influenza virus in a rural setting in Bangladesh
研究概览
简要总结
The next influenza pandemic is expected to spread rapidly in resource-poor settings. Influenza viruses spread from human-to-human via large respiratory droplets. Transmission via large-particle respiratory droplets is believed to be mediated by close contact between infected and susceptible persons or contact with droplet-contaminated fomites. Close contact between infected and susceptible persons may consist of skin-to-skin contact (e.g., via hands) or inhalation of respiratory droplets (e.g., due to talking, coughing, or sneezing by the infected person). Airborne transmission, which is expected to result in transmission over long distances (>1 meter) and which would be mediated by ventilation, is believed to be uncommon. Therefore, the greatest risk of transmission from personal contact comes from those people who are closest to an index case, such as contacts living in the same household. There are, to date, no published estimates of the secondary attack ratio of influenza among household contacts of index case-patients in low-income countries. Moreover, the investigators do not have data on the risk factors for secondary transmission of influenza from index case-patients to their household contacts. There is some data for the benefits of promoting handwashing with soap on the risk of all-cause acute respiratory illness among children < 15 years old in a resource-poor setting in Pakistan. But, the investigators do not have evidence that promoting handwashing with soap will acutely reduce the risk of secondary transmission. Therefore, the investigators propose to conduct a study in rural Bangladesh to assess the following:
- The secondary attack ratio of influenza among household contacts of an index case-patient with influenza
- The risk factors for secondary transmission of influenza from an index case-patient to household contacts
- The impact of promoting handwashing with soap on the risk of secondary transmission of influenza from an index case-patient to household contacts
- The impact of handwashing promotion on handwashing behavior six months after intervention
- The impact of handwashing promotion on the prevalence of respiratory infections, diarrhea and influenza
详细描述
BISTIS builds on hospital-based surveillance for Influenza virus infection, which is ongoing in hospitals around Bangladesh, as part of the Hospital-based Influenza Surveillance (HBIS) and Surveillance for the Epidemiology of Influenza in Bangladesh (SEIB) projects. We intend to recruit patients identified at the Jahurul Islam Medical College Hospital in Kishoregonj, Bangladesh, where both HBIS and SEIB are in place. In this hospital 80% of all the patients who present with influenza-like illness (ILI) to the outpatient departments of Medicine and Pediatrics are from three upazillas of Kishorgonj district: Bajitpur, Kuliar char and Kotiadi. The distances of these three upazillas are within 30 minutes travel time from Jahurul Islam Medical College Hospital (one way) and hence these upazillas will serve as the primary catchment areas for BISTIS. The table below illustrates the number of ILI cases identified through HBIS and SEIB study at Jahurul Islam Medical College Hospital in 2008 and also the number and proportion among them who were tested PCR positive for influenza virus.
n.b., most influenza-positive specimens were collected between May and September in 2007 and 2008
We will also enroll patients who present to two local upazilla health complexes (UHCs), one in Bajitpur and one in Kuliar Char. These local health complexes see numerous patients a day from the rural areas surrounding the clinic. Patients who present to these clinics are more likely to have symptom onset within 24 hours of presentation then those patients who seek care at JIMCH, since patients may only want to go to the hospital if their illness has been severe and prolonged over several days. Some studies on the impact of handwashing promotion have found that the intervention is effective if delivered within 36 hours of the index case-patient's symptom onset; therefore, the UHC sites are appropriate for enrollment of patients for BISTIS in addition to enrollment at JIMCH.
Lastly, we will recruit patients from pharmacies within the catchment areas mentioned above. By collaborating with local pharmacists, we intend on further increasing our enrollment numbers. Patients who present to local pharmacists are likely to have symptom onset within 24 hours of their visit to the pharmacist and are also more likely to be the primary case within their bari.
Specific Aim 1: To measure the secondary attack ratio (SAR) of influenza viruses among household contacts of index cases with influenza, in a rural setting in Bangladesh
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons ≥ 5 years old: Influenza-like illness (ILI), defined as history of fever and either cough or sore throat with fever onset within the previous 24 hours
- •Persons < 5 years old: any child with acute fever with onset within the previous 24 hours
- •Return to home within 24 hours of presentation to Upazilla Health Complex, Jahurul Islam Medical College Hospital or the local pharmacies; i.e., the index case cannot be admitted for treatment. If admitted, the patient would not be eligible.
- •No fever in any bari resident during the 7 days preceding the patient's presentation to hospital (see definition below)
- •At least two persons (in addition to the index case-patient) who intend to reside in the bari during the subsequent 20 days
- •Residence within 30 minutes travel time (one-way) from the Upazilla Health Complex or Jahurul Islam Medical College Hospital or the local pharmacy.
排除标准
- 未提供
结局指标
主要结局
To test the efficacy of a handwashing promotion intervention for prevention of intrahousehold transmission of influenza virus in a rural setting in Bangladesh
时间窗: 17 months
次要结局
- To measure the secondary attack ratio of influenza among household contacts of influenza-infected persons in a rural setting in Bangladesh influenza-infected persons in a rural setting in Bangladesh(17 months)