Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections

Area of Science:

• Neonatalogy
• Pediatric Infectious Diseases
• Clinical Pharmacology

Background:

• Complicated intraabdominal infections (cIAIs) are a significant cause of illness and death in premature infants.
• Established antibiotic regimens lack proven safety and efficacy data in this vulnerable population.

Purpose of the Study:

• To evaluate the safety and effectiveness of three common antibiotic regimens for treating cIAIs in premature infants.
• To compare mortality rates and adverse events across different antibiotic treatment groups.

Main Methods:

• A randomized trial enrolled premature infants (≤33 weeks gestational age) with cIAIs, comparing ampicillin/gentamicin/metronidazole, ampicillin/gentamicin/clindamycin, and piperacillin-tazobactam/gentamicin.
• A protocol amendment allowed non-randomized enrollment for infants already on study regimens.
• Primary outcome was 30-day mortality post-treatment; secondary outcomes included adverse events and therapeutic success.

Main Results:

• 180 infants were enrolled (128 randomized, 52 non-randomized).
• 30-day mortality rates were similar across the three groups (8%, 7%, 9%).
• No significant differences in safety outcomes were observed between the antibiotic regimens.

Conclusions:

• All evaluated antibiotic regimens demonstrated safety in premature infants diagnosed with cIAIs.
• The findings support the use of these antibiotic combinations for treating cIAIs in this patient group.