Neonates 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
Conditions
Interventions
In the proposed trial, CRP POCT equipment is scheduled to be supplied to the selected hospitals, accompanied by training sessions on its use and interpretation to support the clinical evaluation of ne
Sponsors
International Centre for Antimicrobial Resistance Solutions (ICARS)
Eligibility
Sex/Gender
All
Age
0 Days to 12 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Antibiotic consumption measured using records quantifying prescribed daily doses and daily defined dosage throughout the entire duration of antibiotic treatment at the end of the study 2. Antibiotics prescribed at birth or admittance measured using records of the type and dosage of antibiotics prescribed at the time of birth or admittance to the hospital at the end of the study 3. The number of days admitted in the hospital measured using records of the total days from admission to discharge until the patient was discharged at the end of the study 4. The number of days until the resolution of symptoms measured using records tracking the time from initial symptoms to complete resolution until symptoms are completely resolved at the end of the study 5. The number of days until discharge measured using records counting the days from admission to hospital discharge until the patient is discharged at the end of the study 6. Development of clinical signs of sepsis measured using records of the clinical assessment for the presence of sepsis indicators throughout the entire study duration 7. The number of days in antibiotic treatment (Drugs, Doses Administered) measured using records of the duration and dosage of antibiotic treatment throughout the entire duration of antibiotic therapy 8. The number of blood cultures before antibiotic treatment measured using records counting the instances of blood cultures taken before antibiotic initiation before the initiation of antibiotic treatment 9. Choice of antibiotic treatment according to local guidelines measured using records of the prescribed antibiotics in alignment with local guidelines at the time of antibiotic prescription at the end of the study 10. Re-admittance within 14 days measured using records tracking instances of re-admittance within 14 days following the initial discharge 11. Mortality measured using records documenting instances of patient mortality throughout the entire study duration | — |
Countries
Tanzania
Contacts
Public ContactDaniel;Jeremia Joshua;Seni
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Outcome results
None listed