Using CRP trends to reduce antibiotic exposure in neonates
Research type
Research Study
Full title
Evaluation of using C-Reactive Protein (CRP) levels at 36 hours to reduce antibiotic exposure in neonates with suspected early onset sepsis (EOS) in the neonatal unit at Luton and Dunstable Hospital.
IRAS ID
238539
Contact name
Sakina Ali
Contact email
Sponsor organisation
Luton and Dunstable hospital
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
Early onset sepsis (EOS) in the neonate is defined as infection occurring in the first 72 hours of life. NICE provides guidance (CG149) on which population of neonates is at risk of EOS.
Bloods are taken and empirical antibiotics are commenced. Blood culture results take between 36-48 hours to be reported. A further CRP is advised to be taken at 18-24 hours after the initial CRP. At 36 hours, NICE guides clinicians to review the patient, trends of CRPs and blood culture results to inform a decision regarding stopping antibiotics or continuing them.
Therapeutic drug monitoring is routinely performed, since one of the antibiotics, gentamicin, can cause both oto- and nephrotoxicity if the plasma levels are too high. Therefore it is normal clinical practice for a further blood test to be taken at 36 hours to measure the plasma level of gentamicin.
In summary, in EOS, blood tests are routinely required prior to commencement of antibiotics, 18-24 hours later and again at 36 hours.
This evaluation proposes to initially add in a further CRP blood test at 36 hours with the gentamicin level to give further information on CRP trends. This additional test can be performed from the same specimen as that used for gentamicin levels It is hypothesised the evaluation will show it is feasible to time the second CRP at 36hours (and remove the need for performing this test at 24 hours) using the same blood sample for gentamicin level and thereby reducing the number of blood sampling episodes.
Furthermore it is proposed that by doing the CRP at 36 hours, knowledge of this result may result in some babies having their course of antibiotics stopped earlier. That is because currently, a mild rise of CRP at 18-24 hours normally results in an empirical 5 day course of antibiotics.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
18/EE/0116
Date of REC Opinion
23 Apr 2018
REC opinion
Unfavourable Opinion