Status: Funded - Closed
Carbapenem vs. therapy with other b-lactam antibiotics for the treatment of gram-negative bacteremia in children
Beatriz Larru, M.D., Ph.D.
BACKGROUND: Gram-negative bacteremia in children is a life-threatening condition with little data to help guide appropriate antimicrobial use. Antibiotic resistance among gram-negative bacteria (MGRGNs) has reached critical levels and represents a major clinical problem worldwide.
GAP: A recent meta-analysis comparing carbapenems vs. alternative antibiotics for the treatment of MGRGNs bacteremia concluded that carbapenems could be considered the drug of choice for empirical treatment. Of note, only 2 of the 21 studies included in the meta-analysis had pediatric data. Drawing definitive conclusions regarding the optimal treatment of infections in children based in adult studies is not always straightforward. Thus, pediatric studies are necessary to guide treatment recommendations for children with severe infections.
HYPOTHESIS: Specific Aim: To compare carbapenem monotherapy vs. combination antibiotic therapy with other β -lactam antibiotic for the definitive treatment of Gram-negative bacteremia in hospitalized children. Hypothesis: combination therapy is not inferior to carbapenem monotherapy.
METHODS: Retrospective cohort study of all patients ≤ 18 years of age, admitted to Children’s Hospital of Philadelphia between 1st January 2000 and 31st December 2012 with Gram-negative bacteremia. Data will be analyzed using a fixed effect regression model to compare the clinical course of patient receiving carbapenem vs. other antibiotics.
IMPACT: Children carry the burden of Gram-negative bacteria infections and the lack of evidence regarding the optimal antimicrobial treatment to use impairs their care. Our pediatric study will provide novel data to determine the effectiveness of carbapenems sparing therapies powered to examine the effect in most relevant pediatric subpopulations—an issue currently hindering studies performed to date.
The Children's Hospital of Philadelphia