sing procalcitonin to guide duration of antibiotics
- Conditions
- Bacterial infectionInfections and Infestations
- Registration Number
- ISRCTN11369832
- Lead Sponsor
- niversity of Liverpool
- Brief Summary
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35078830/ (added 27/01/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1951
Current inclusion criteria as of 07/11/2019:
1. All children aged between 72 hours old and up to 18 years old admitted to hospital for confirmed or suspected SBI, in whom IV antibiotics are commenced, and expected to remain on IV antibiotics for more than 48 hours
2. Conditions include (but not limited to): bacteraemia, central line-associated bloodstream infections (CLABSIs), uncomplicated bone and joint infections (such as single site infection, osteomyelitis with adjacent septic arthritis or septic arthritis with adjacent osteomyelitis), discitis, empyema, pneumonia, pyelonephritis, sinusitis, retropharyngeal abscess, pyomyositis, uncomplicated culture-negative meningitis, intra-abdominal infections, lymphadenitis, cellulitis
3. First time in the BATCH trial
Previous inclusion criteria from 02/05/2018 to 07/11/2019:
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
Original 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, empyema, pneumonia, pyelonephritis, sinusitis, retropharyngeal abscess, pyomyositis, uncomplicated culture-negative meningitis, intra-abdominal infections, lymphadenitis, cellulitis, bacterial endocarditis
Current exclusion criteria as of 07/11/2019:
1. Preterm infant age
2. Children admitted moribund and not expected to survive more than 24 hours
3. Children with a predicted duration of intravenous (IV) antibiotics of less than 48 hours
4. Children not expected to survive at least 28 days because of a pre-existing condition
5. Children with bacterial meningitis, bacterial endocarditis, or brain abscess
6. Children with complicated bone and joint infections
7. Children receiving antibiotics for surgical prophylaxis
8. Children with chronic co-morbidities, such as cystic fibrosis, chronic lung disease, bronchiectasis where there is already a pre-defined length of course of antibiotics
9. Children who are severely immunocompromised (e.g. chemotherapy, stem cell transplant, biological therapy for inflammatory or rheumatological conditions)
10. Children who in the opinion of the local investigator, are unsuitable for randomisation due to high probability of requiring sustained IV therapy
11. Children with a presence of existing directive to withhold life-sustaining treatment
12. Added 01/02/2021: Inborn infants admitted to Neonatal Intensive Care Units (NICU), Neonatal High Dependency Units (NHDU), Special Care Baby Units (SCBU) or Postnatal wards
Previous exclusion criteria:
1. Preterm infant age <37 weeks corrected gestational age or =18 years of age
2. Children admitted moribund and not expected to survive more than 24 hours
3. Children with a predicted duration of stay of less than 48 hours
4. Children not expected to survive at least 28 days because of a pre-existing condition
5. Bacterial meningitis, bacterial endocarditis, brain abscess
6. Children receiving antibiotics for surgical prophylaxis
7. Chronic co-morbidities, such as cystic fibrosis, chronic lung disease, bronchiectasis
8. Severe immunocompromised (e.g. chemotherapy, stem cell transplant, biological therapy for inflammatory or rheumatological conditions, TPN dependent)
9. Presence of existing directive to withhold life-sustaining treatment
10. Added 02/05/2018: Children, who in the opinion of the local investigator, are unsuitable for randomisation due to high probability of requiring long term IV therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Antibiotics use is measured using the number of days IV antibiotics are used<br>2. Safety is measured as the number of patients experiencing one of:<br>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)<br>2.2. Re-treatment for same condition within 7 days of stopping IV antibiotics (re-starting IV antibiotics which have been stopped),<br>2.3. Mortality
- Secondary Outcome Measures
Name Time Method