Efficacy of Antibiotic Regimens for Sepsis or Possible Serious Bacterial Infection in Young Infants Aged 0 to 59 Days: A Systematic Review and Meta-analysis

• Published in: Pediatrics (Evanston) 2024-08, Vol.154 (Suppl 1), p.1
• Main Authors: North, Krysten, Mathias, Sitarah, Schmeck, Naomi, Kim, Yumin, Kehoe, Tessa, Folger, Lian V, Hoey, Amber, Wade, Carrie, Driker, Sophie, Chou, Roger, Edmond, Karen M, Lee, Anne Cc
• Format: Article
• Language: English
• Subjects: Amoxicillin; Ampicillin; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - therapeutic use; Antibiotics; Babies; Bacterial infections; Bacterial Infections - drug therapy; Cephalosporins; Clinical outcomes; Clinical trials; Gentamicin; Humans; Infant; Infant mortality; Infant, Newborn; Infants; Intravenous administration; Meta-analysis; Penicillin; Randomized Controlled Trials as Topic; Sepsis; Sepsis - drug therapy; Systematic review; Treatment Outcome
• ISSN: 0031-4005; 1098-4275; 1098-4275
• DOI: 10.1542/peds.2024-066588F

Sepsis is a leading cause of young infant mortality. To evaluate the efficacy of different antibiotic regimens to treat young infant sepsis or possible serious bacterial infection (PSBI) on clinical outcomes. MEDLINE, Embase, CINAHL, World Health Organization Global Index Medicus, Cochrane Central Registry of Trials. We included randomized controlled trials (RCTs) of young infants 0 to 59 days with sepsis or PBSI (population) comparing the efficacy of antibiotic regimens (intervention) with alternate regimens or management (control) on clinical outcomes. We extracted data and assessed risk of bias in duplicate. We performed random-effects meta-analysis, and used Grading of Recommendations, Assessment, Development, and Evaluation to assess certainty of evidence. Of 2390 publications, we included 41 RCTs (n = 18 054). Thirty-five trials were hospital-based and 6 were nonhospital-based. Meta-analysis of 4 trials demonstrated similar rates of treatment success with intramuscular/intravenous third generation cephalosporins versus intramuscular/intravenous penicillin or ampicillin + gentamicin (RR 1.03, 95% CI 0.93-1.13]; n = 1083; moderate certainty of evidence). Meta-analysis of 3 trials demonstrated similar rates of treatment failure with oral amoxicillin + intramuscular gentamicin versus intramuscular penicillin + gentamicin for nonhospital treatment of clinical severe illness (RR 0.86, 95% CI 0.72-1.02]; n = 5054; low certainty of evidence). Other studies were heterogeneous. RCTs evaluated heterogeneous regimens, limiting our ability to pool data. We found limited evidence to support any single antibiotic regimen as superior to alternate regimens to treat young infant sepsis or PSBI.