NeoNotes
Journal Club
Andrew B. Kairalla MD, Editor
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Sepsis Screening
Measurement of Interleukin 8 in Combination With C-Reactive Protein Reduced Unnecessary Antibiotic Therapy in Newborn Infants: A Multicenter, Randomized, Controlled Trial. Franz AR, Bauer K, Schalk A, et al. PEDIATRICS (July 2004);114:1-8.
Objective. Neonatal bacterial infections carry a high mortality when diagnosed late. Early diagnosis is difficult because initial clinical signs are nonspecific. Consequently, physicians frequently prescribe antibiotic treatment to newborn infants for fear of missing a life-threatening infection. This study was designed to test the hypotheses that a diagnostic algorithm that includes measurements of interleukin 8 (IL-8) and C-reactive protein (CRP) 1) reduces antibiotic therapy and 2) does not result in more initially missed infections compared with standard management that does not include an IL-8 measurement.
Methods. Term and preterm infants who were <72 hours of age and had clinical signs or obstetric risk factors suggesting neonatal bacterial infection but stable enough to wait for results of diagnostic tests were enrolled into the study. A total of 1291 infants were randomly assigned to receive antibiotic therapy according to the guidelines of each center (standard group) or to receive antibiotic therapy when IL-8 was >70 pg/mL and/or CRP was >10 mg/L (IL-8 group). The primary outcome variables were 1) the number of infants treated with antibiotics and 2) the number of infants with infections missed at the initial evaluation.
Results. In the IL-8 group, fewer infants received antibiotic therapy than in the standard group (36.1% [237 of 656] vs. 49.6% [315 of 635]). In the IL-8 group, 24 (14.5%) of 165 infants with infection were not detected at the initial evaluation, compared with 28 (17.3%) of 162 in the standard group.
Conclusions. The number of newborn infants who received postnatal antibiotic therapy can be reduced with a diagnostic algorithm that includes measurements of IL-8 and CRP. This diagnostic strategy seemed to be safe.
Comments. Be aware that CRP screening was part of the initial evaluation done in the standard group at 7 of the 8 participating centers. In those centers, only IL-8 screening was added. The IL-8 test is not currently available in our clinical lab, and I’m not sure if it is widely available elsewhere. Also, the percentage of infections missed by initial screening (14% vs. 17%) seems high in both groups. ABK.
Date: 09 Aug 2004
Time: 22:01:38
I completely agree with Andy's assessment, that missing 14-16% with some
screening test is high--in fact, I submit that it is unacceptable. We need to
decrease antibiotic use, no doubt, but for the individual patient, the risks of
antibiotics is quite low, and certainly below 14% complication rate which one
might assume if infections are missed or treatment delayed.
To date, I am underwhelmed with all non-specific screening tests.
UserName: David J. Burchfield, MD
Institution: University of Florida
telephone: 352-392-4195
email: burchdj@peds.ufl.edu
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