Effectiveness of the C-reactive protein point-of-care testing in optimizing antibiotic treatment in neonates and children: an open-label, individual randomized controlled trial

International Centre for Antimicrobial Resistance Solutions (ICARS)0 个研究点目标入组 2,261 人开始时间: 2024年1月22日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•1. Between 0-28 days (inclusive) and fulfilling one of two inclusion criteria
•1.1. Newborns at risk of early onset sepsis according to the WHO criteria and therefore eligible for prophylactic antibiotic treatment example:
•1.1.1. Membranes ruptured over 18 hours before delivery or
•1.1.2. Maternal fever (over 38 °C) during labour or
•1.1.3. Amniotic fluid is foul smelling or purulent
•1.2. All children from day 0 to day 28 admitted with suspected sepsis (clinical signs subjectively judged by the clinician)
•2. Children between 6 months and 12 years with need of admission with either:
•2.1. Febrile illness with a temperature above 38 degrees or below 36 degrees at admission, or a history of febrile illness within the last 72 hours
•2.2. Diarrhea disease (defined as the passage of 3 or more loose or liquid stools per day) with or without fever
•3. Parents/caregivers of admitted children are able and willing to comply with all study requirements
•4. Parents/caregivers of admitted children are able and willing to give voluntary Informed consent

•1. Age >28 days until 6 months
•2. Severely ill where measurement of CRP POCT would delay the treatment process
•3. Neonates who need surgery or have major congenital malformations that will require hospital admission
•4. Children with known immunosuppression or severe chronic disease (HIV, hepatic disease, history of neoplastic disease, long-term systemic steroid use or similar conditions as assessed by the health care worker)
•5. Parents/caregivers who are not able to participate in follow-up procedures
•6. Positive rapid diagnostic test for malaria
•7. Have taken antibiotics within 24 hours before admittance

发起方

International Centre for Antimicrobial Resistance Solutions (ICARS)