Effectiveness of C-reactive protein testing for optimising antibiotic treatment in neonates and children in Zanzibar

Not Applicable

• Conditions: eonates at risk of early onset sepsis, admitted neonates (0-28 days) with clinical signs of sepsis and admitted children (6 months to 12 years) with febrile illness or diarrhea; Infections and Infestations

• Registration Number: ISRCTN25937092
• Lead Sponsor: International Centre for Antimicrobial Resistance Solutions (ICARS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-22
• Last Update Posted: 8 July 2024
• Study Completion: 2024-10-13

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2261

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Duration of antibiotic treatment (number of 24-hour periods between the start and end of antibiotic treatment) measured using g patient medical records and clinical data registry filled by research assistants daily within 14 days of the admittance of included neonates and children in each study arm (superiority analysis) <br>2. Days to relapse of infection measured using patient medical records and follow-up forms within 72 hours after completion of the initial course of antibiotics and at the 7th and 28th day after randomization<br><br>