Department of Clinical Sciences, Tropical Diseases Research Centre, Ndola, Zambia.
Department of Epidemiology and Biostatistics, University of Zambia, Lusaka, Zambia.
BMJ Open. 2024 Aug 21;14(8):e080607. doi: 10.1136/bmjopen-2023-080607.
Sepsis, a condition of global public health concern, is a major cause of morbidity and mortality, especially in patients with underlying HIV infection. This study aims to determine outcomes, aetiology and antibiotic resistance patterns among children with HIV exposure or infection admitted with a clinical presentation suggestive of sepsis who have confirmed bloodstream infections at Arthur Davison Children's Hospital (ADCH) in Ndola, Zambia.
This will be a prospective longitudinal study of 200 children aged <2 years admitted with sepsis at ADCH with two of the following conditions: temperature of 38.0°C, respiratory rate ≥20 breaths per minute and pulse rate ≥90 beats per minute. About 2-5 mL of blood collected from each participant will be inoculated into BACTEC culture bottles and incubated for 5-7 days. Positive cultures will be inoculated onto culture media for subculture followed by species identification followed by antibiotic susceptibility testing. Time-to-event outcomes such as hospital readmission and mortality will be analysed using Kaplan-Meier and Cox proportional hazards. Predictors will be identified using regression methods. All statistical tests will use a 5% significance level with a 95% confidence level. STATA V.16 will be used for statistical analysis.
Ethical clearance and approval have been granted by the Tropical Diseases Research Centre Ethics Committee (TDRC-EC 092/07/23). Caregiver consent will be obtained verbally for participants presenting as medical emergencies, and written informed consent will be obtained once stable. Findings from this study will be shared with the Ministry of Health Zambia and will be disseminated to the scientific community through peer-reviewed scientific journals.
败血症是一种全球公共卫生关注的病症,是发病率和死亡率的主要原因,尤其是在患有潜在 HIV 感染的患者中。本研究旨在确定赞比亚恩多拉亚瑟·戴维森儿童医院(ADCH)收治的具有疑似败血症临床症状且已确诊血流感染的 HIV 暴露或感染儿童的结局、病因和抗生素耐药模式。
这将是一项前瞻性纵向研究,纳入 200 名年龄<2 岁、在 ADCH 因败血症住院的儿童,符合以下两项标准之一:体温≥38.0°C、呼吸频率≥20 次/分钟和脉搏率≥90 次/分钟。从每个参与者采集约 2-5mL 的血液,接种到 BACTEC 培养瓶中,孵育 5-7 天。阳性培养物将接种到培养基中进行传代培养,然后进行物种鉴定,随后进行抗生素敏感性测试。使用 Kaplan-Meier 和 Cox 比例风险分析来分析时间相关结局,如住院再入院和死亡率。使用回归方法确定预测因子。所有统计检验将使用 5%的显著性水平和 95%的置信水平。将使用 STATA V.16 进行统计分析。
热带病研究中心伦理委员会(TDRC-EC 092/07/23)已批准本研究的伦理审查和批准。对于表现为医疗紧急情况的参与者,将口头获得照顾者的同意,一旦病情稳定,将获得书面知情同意。本研究的结果将与赞比亚卫生部共享,并通过同行评议的科学期刊向科学界传播。