Azithromycin to prevent post-discharge morbidity and mortality in Kenyan children

阿奇霉素可预防肯尼亚儿童出院后发病率和死亡率

基本信息

批准号：
9212170
负责人：
Judd L. Walson
金额：
$ 59.92万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-04-01 至 2020-02-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9212170
关键词：
5 year old 9 year old Acute respiratory infection Admission activity Affect Africa Africa South of the Sahara Age Amoxicillin Antibiotic Resistance Antibiotics Antimicrobial Resistance Area Azithromycin Benefits and Risks Cessation of life Child Childhood Cluster randomized trial Communities Cost Effectiveness Analysis Costs and Benefits Cotrimoxazole Diarrhea Drug resistance Enteral Escherichia coli Ethiopia Functional disorder Future Guidelines HIV Hospitalization Hospitalized Child Hospitals Household Immune Immune System Diseases Immune System and Related Disorders Immunosuppression Individual Inflammation Inpatients Intervention Kenya Lactams Macrolide-resistance Macrolides Malnutrition Morbidity - disease rate Organism Pathogenicity Pharmaceutical Preparations Placebos Population Prevalence Prophylactic treatment Randomized Recording of previous events Residual Tumors Resistance Resources Risk Streptococcus pneumoniae Symbiosis Time Toxic effect Trachoma Vulnerable Populations arm cost effective cost effectiveness double-blind placebo controlled trial experience follow-up gastrointestinal high risk high risk population hospital readmission mortality novel pathogen prevent primary caregiver programs public health relevance respiratory risk minimization targeted delivery

项目摘要

DESCRIPTION (provided by applicant): Children hospitalized with severe illness in sub-Saharan Africa are at high risk of morbidity and mortality following discharge from hospital. These children represent an accessible high-risk population in which targeted interventions to prevent morbidity and mortality could have dramatic impact. A large cluster randomized trial of azithromycin delivered in a mass drug administration program within trachoma endemic areas in sub-Saharan Africa demonstrated an almost 50% mortality benefit in children 1-9 years of age in treated communities. However, mass drug administration of azithromycin leads to the rapid emergence of macrolide resistance within treated communities and is expensive. The targeted delivery of azithromycin to children at hospital discharge may be a novel and practical intervention to maximize benefit while minimizing risk of antibiotic resistance. We propose a randomized, double-blind, placebo-controlled trial to determine the efficacy of azithromycin provided at discharge, compared to placebo, in reducing mortality and re-hospitalization rates in children age 1-59 months in Kenya. The study will also investigate potential mechanisms by which azithromycin may reduce morbidity and mortality in this population and will assess the emergence of antibiotic resistance among treated individuals and their primary caregivers. A cost-effectiveness analysis of the intervention will also be conducted.

描述（由申请人提供）：撒哈拉以南非洲地区因重病住院的儿童出院后发病和死亡的风险很高。这些儿童是容易接触到的高危人群，预防发病和死亡的有针对性的干预措施可能会产生巨大影响。在撒哈拉以南非洲沙眼流行地区的一项大规模药物管理计划中，阿奇霉素的一项大型整群随机试验表明，接受治疗的社区 1-9 岁儿童的死亡率可降低近 50%。然而，阿奇霉素的大规模给药导致接受治疗的社区内迅速出现大环内酯类耐药性，并且费用昂贵。向出院儿童有针对性地施用阿奇霉素可能是一种新颖且实用的干预措施，可以最大限度地提高效益，同时最大限度地降低抗生素耐药性的风险。我们提出了一项随机、双盲、安慰剂对照试验，以确定与安慰剂相比，出院时提供的阿奇霉素在降低肯尼亚 1-59 个月儿童死亡率和再住院率方面的功效。该研究还将调查阿奇霉素可能降低该人群发病率和死亡率的潜在机制，并将评估治疗个体及其主要护理人员中抗生素耐药性的出现。还将对干预措施进行成本效益分析。