Using procalcitonin to guide duration of antibiotics

Category Primary study
Registry of TrialsISRCTN registry
Year 2017
INTERVENTION: Children hospitalised with suspected or confirmed bacterial infection are randomised to the intervention or control arm. In those randomised to the intervention arm, a Procalcitonin (PCT) test is performed in the hospital laboratory at baseline, days 3‐5, days 6‐14 and day 28 (if still on IV antibiotics). The PCT results feed into an algorithm that guides antimicrobial prescribing decisions. Children in the control arm do not have the PCT test performed and receive care as usual. At Day 28, participants receive a telephone or electronic follow up with the parent to ask about the healthcare utilisation and quality of life of the child. CONDITION: Bacterial infection ; Infections and Infestations ; Bacterial infection PRIMARY OUTCOME: 1. Antibiotics use is measured using the number of days IV antibiotics are used; 2. Safety is measured as the number of patients experiencing one of:; 2.1. Unscheduled admissions/re‐admissions (to include readmission rate within 7 days of discharge with infective diagnosis, unscheduled readmission to PICU with infective diagnosis, or admission to PICU with infective diagnosis); 2.2. Re‐treatment for same condition within 7 days of stopping IV antibiotics (re‐starting IV antibiotics which have been stopped),; 2.3. Mortality SECONDARY OUTCOME: 1. Total duration of antibiotics (IV and oral) ; 2. Unscheduled admissions/re‐admissions (to include readmission rate within 7 days of discharge with infective diagnosis, unscheduled readmission to PICU with infective diagnosis, or admission to PICU with infective diagnosis.); 3. Re‐treatment for same condition within 7 days of stopping IV antibiotics (re‐starting IV antibiotics which have been stopped); 4. Time to switch from broad spectrum to narrow spectrum antibiotics; 5. Time to discharge from hospital; 6. Suspected Adverse Drug Reactions (ADR) is measured using the Liverpool Causality Assessment Tool.; 7. Cost of hospital episode is measured using cost analysis.; 8. Hospital Acquired Infection (HAI) is measured using up to Day 28; 9. Health utility is measured using CHU9D (for children aged 5 and above) up to Day 28.; 10 Mortality.; ; Outcome data is recorded daily by the research nurse for all recruited participants (up to and including Day 28, or until discharge). Research nurses review observation and medication charts, medical notes for all recruited participants. INCLUSION CRITERIA: Current inclusion criteria (as of 02/05/2018): 1. All children up to 18 years old admitted to hospital for confirmed or suspected bacterial infection or sepsis, in whom IV antibiotics are commenced, and expected to remain on IV antibiotics for at least 48 hours 2. Conditions include: bacteraemia, bone and joint infections, discitis, empyema, pneumonia, pyelonephritis, sinusitis, retropharyngeal abscess, pyomyositis, uncomplicated culture‐negative meningitis, intra‐abdominal infections, lymphadenitis, cellulitis, central line‐associated bloodstream infections (CLABSIs) and bacterial endocarditis 3. First time in the BATCH trial. Previous INCLUSION CRITERIA: 1. All children up to 18 years old admitted to hospital for confirmed or suspected bacterial infection or sepsis, in whom IV antibiotics are commenced, and expected to remain on IV antibiotics for at least 48 hours 2. Conditions include: bacteraemia, bone and joint infections, discitis, empy
Epistemonikos ID: 83bd1d86f52f7ec8aa2d35c621d9fece66e1b0cb
First added on: Jan 30, 2022