Data on the efficacy and safety of ceftazidime-avibactam (CAZ/AVI) in children are limited. Therefore, a sys­tematic review was conducted to address the following ques­tion: Is the CAZ/AVI combination more effective and safer than other comparator antibiotics for the treatment of severe gram-negative bacilli infections in children? Procedure: Literature searches were performed in Medline, Embase, The Cochrane Library, CINAHL, SCI-EXPANDED, and Scopus. Only random­ized controlled trials involving subjects aged ≤18 years were included. Studies had to report on patients receiving empirical treatment or treatment for documented infections caused by susceptible microorganisms with CAZ/AVI or a comparator antibiotic, as well as their outcomes and adverse effects. A meta-analysis was conducted using the DerSimonian-Laird method, and heterogeneity was assessed with the I2 indica­tor. Results: Out of 1,673 articles identified, only two met the inclusion criteria and were subsequently reviewed in full. Both studies were primary experimental phase II trials: one focused on patients with intra-abdominal infections, and the other on patients with renal infections. The estimation of statistical het­erogeneity for efficacy indicated high heterogeneity, which was attributed to the differing diagnoses (intra-abdominal infections and pyelonephritis). However, the heterogeneity was not ex­cessive enough to preclude a meta-analysis. For the evalua­tion of adverse events, the I2 value was negative, indicating an absence of heterogeneity. The probability of publication bias was inevitably high due to the limited number of eligible studies. Interpretation: This systematic review concludes that it was not possible to establish the superiority of CAZ/AVI over the comparator antibiotics, meropenem for intra-abdominal infections and cefepime for pyelonephritis. Both treatments demonstrated an acceptable safety profile in children. The incidence of adverse events was comparable between groups, and none of the drug-related events were serious.

Rosanova Maria Teresa is a medical professional affiliated with Hospital Juan P. Garrahan in Argentina. With expertise in the healthcare field, she contributes to the advancement of medical practices and patient care at one of the country's leading pediatric hospitals. Her work reflects a commitment to improving the health and well-being of children through clinical practice and research.