Community-based interventions to reduce mortality from neonatal infection

描述（由申请人提供）：该申请提供证据，证明美国负责人和高级外国研究员在参与全球网络活动以及设计、实施和发布单站点和通用协议研究和临床试验方面具有既定的领导记录。在接下来的5年周期中，提出了两项严格设计的抗生素治疗疑似严重细菌感染婴儿的随机临床试验。感染是婴儿死亡的主要原因之一，约占全世界新生儿死亡率的36%。目前世界卫生组织（世卫组织）关于治疗疑似严重细菌感染的婴儿的建议包括注射抗生素治疗，但在发展中国家的许多社区，静脉注射或肌肉注射抗生素的能力有限。由于前往医院的机会有限，患病婴儿不可能经常住院。即使在一些设施中，注射抗生素也可能难以施用。此外，感染或脓肿形成以及人类免疫缺陷病毒、肝炎或其他病原体的传播在发展中国家更为常见。口服抗生素方案对大龄婴儿和肺炎儿童有效，但对怀疑严重细菌感染的新生儿和年幼婴儿无效。在世卫组织指导下的专家顾问建议，对怀疑患有严重细菌感染的婴儿评估纯口服抗生素方案，以替代注射抗生素。因此，迫切需要评估早期识别和创新但简单的抗生素治疗方案的有效性，以治疗低收入和中等收入国家怀疑患有严重细菌感染的幼儿。如果发现口服抗生素方案对疑似严重细菌感染的婴儿有效，那么对疑似严重细菌感染的婴儿进行抗生素治疗可能会显著降低全世界新生儿和婴儿的死亡率和发病率。拟议的研究小组将与NICHD和全球妇女儿童健康研究网络的其他站点合作，设计、优先考虑、计划、实施、分析、解释和报告有可能改善孕产妇和儿童生存率并降低重要发病率的创新性随机试验和观察性研究。如果该网站被允许继续参与全球网络，那么美国首席调查员、高级外国调查员、赞比亚调查人员和工作人员团队的资格和明确承诺，以及赞比亚政府、赞比亚大学和阿拉巴马大学伯明翰分校的全面认可，将确保该网站的卓越表现。

DESCRIPTION (provided by applicant): This application provides evidence that the U.S. Principal and the Senior Foreign Investigator have an established leadership record in participation in the Global Network activities as well as in the design, implementation, and publication of single site and common protocol studies and clinical trials. For the next 5 year cycle, two rigorously-designed randomized clinical trials of antibiotic treatment of infants with suspected serious bacterial infection are proposed. Infection is one of the main causes of death in infants, accounting for about 36% of neonatal mortality worldwide. Current World Health Organization (WHO) recommendations for the treatment of infants with suspected serious bacterial infection include injectable antibiotic therapy but there is limited capacity for intravenous or intramuscular antibiotic administration in many communities in developing countries. Hospitalization of ill infants is not possible frequently because of limited access to hospitals. Injectable antibiotics can be difficult to administer even in some facilities. Furthermore, infection or abscess formation as well as transmission of human immunodeficiency virus, hepatitis, or other pathogens is more common in developing countries. Oral antibiotic regimens have been an effective intervention in older infants and children with pneumonia but not in neonates and young infants with suspected serious bacterial infection. Expert consultants under the direction of WHO have recommended evaluating oral-only antibiotic regimes as alternatives to injectable antibiotics for infants with suspected serious bacterial infection. Thus, there is an urgent need to evaluate the effectiveness of early identification and innovative but simple antibiotic regimens to treat young infants with suspected serious bacterial infection in low and middle income countries. If an oral antibiotic regimen is found to be effective in young infants with suspected serious bacterial infection, antibiotic treatment to young infants with suspected serious bacterial infection may result in an important reduction in neonatal and infant mortality and morbidity worldwide. The proposed team of investigators will work with the NICHD and other sites of the Global Network for Women's and Children's Health Research to design, prioritize, plan, implement, analyze, interpret, and report innovative randomized trials and observational studies that are likely to improve maternal and childhood survival and reduce important morbidities. The qualifications and unequivocal commitment of the U.S. Principal Investigator, the Senior Foreign Investigator, and the team of investigators and staff in Zambia, as well as the full endorsement of the Government of Zambia, the University of Zambia, and the University of Alabama at Birmingham will ensure superior performance if this site is allowed to continue participation in the Global Network.