A comparison of treatment failure rate between three simplified regimens and a reference regimen for management of possible serious bacterial infections in neonates and young infants.: A multi-centre randomized controlled trial in Africa

World Health Organization0 个研究点目标入组 6,900 人开始时间: 2010年4月9日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Stratum 1 (severe infection): One or more of the following five signs of 'severe infection' - not feeding well, movement only when stimulated, severe chest indrawing, axillary temperature >38.0 degree Centigrade or <35.5 degree Centigrade and informed consent is provided by a parent (or legal guardian).
•Stratum II (fast breathing only): Fast breathing i.e., respiratory rate 60 or more per minute and Informed consent is provided by a parent (or legal guardian)

•Stratum I: Exclusion Criteria
•- Critically ill infant characterized by presence of any of the following signs - unconscious, convulsions, unable to feed at all, apnea, unable to cry, cyanosis, bulging fontanelle, major congenital malformations inhibiting oral antibiotic intake, active bleeding requiring transfusion, surgical conditions needing hospital referral, persistent vomiting defined as vomiting following three attempts to feed the baby within ½ hour
•- Very low weight (<1500g at the time of presentation)
•- Hospitalization for illness in the last two weeks
•- Previous inclusion in the study
•Stratum II: Exclusion Criteria
•- Any signs of severe infection: not feeding well, movement only when stimulated, severe chest in-drawing, axillary temperature >38.0 degree Centigrade or <35.5 degree Centigrade ,
•- Any sign of being critically ill
•- Very low weight (<1500g at the time of presentation)
•- Hospitalization for illness in the last two weeks
•- Previous inclusion in the study

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