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Published on: February 9, 2011
Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections
Michael Cohen-Wolkowiez1, Brenda Poindexter, Margarita Bidegain
1Department of Pediatrics, Duke University, Durham, North Carolina 27715, USA.
Background:
Intra-abdominal infections are common in young infants and lead to significant morbidity and mortality. Meropenem is a broad-spectrum antimicrobial with excellent activity against pathogens associated with intra-abdominal infections. The purpose of this study was to determine the safety and effectiveness of meropenem in young infants with suspected or complicated intra-abdominal infections.
Methods:
Preterm and term infants <91 days of age with suspected or confirmed intra-abdominal infections hospitalized in 24 neonatal intensive care units were studied in an open-label, multiple-dose study. Adverse events and serious adverse events were collected through 3 and 30 days following the last meropenem dose, respectively. Effectiveness was assessed by 3 criteria: death, bacterial cultures, and presumptive clinical cure score.
Results:
Of 200 subjects enrolled in the study, 99 (50%) experienced an adverse event, and 34 (17%) had serious adverse events; no adverse events were probably or definitely related to meropenem. The most commonly reported adverse events were sepsis (6%), seizures (5%), elevated conjugated bilirubin (5%), and hypokalemia (5%). Only 2 of the serious adverse events were determined to be possibly related to meropenem (isolated ileal perforation and an episode of fungal sepsis). Effectiveness was evaluable in 192 (96%) subjects, and overall treatment success was 84%.
Conclusions:
Meropenem was well tolerated in this cohort of critically ill infants, and the majority of infants treated with meropenem met the definition of therapeutic success.
Clinical Trials Registration:
NCT00621192.
Insights
Meropenem demonstrated safety and effectiveness in treating intra-abdominal infections in infants under 91 days old. The majority of critically ill infants achieved therapeutic success with this broad-spectrum antimicrobial.
Area of Science:
- Neonatal Medicine
- Pediatric Infectious Diseases
- Pharmacology
Background:
- Intra-abdominal infections pose significant risks to young infants, contributing to morbidity and mortality.
- Meropenem, a broad-spectrum antimicrobial, exhibits potent activity against common pathogens implicated in these infections.
Purpose of the Study:
- To evaluate the safety and efficacy of meropenem for treating suspected or complicated intra-abdominal infections in neonates and young infants.
Main Methods:
- An open-label, multiple-dose study involving 200 infants (<91 days) across 24 NICUs.
- Adverse events were monitored up to 30 days post-treatment; effectiveness assessed via mortality, cultures, and clinical cure scores.
Main Results:
- Overall treatment success was 84% in 192 evaluable infants.
- 50% experienced adverse events, 17% serious adverse events; most were unrelated to meropenem.
- Common adverse events included sepsis, seizures, and elevated bilirubin; only two serious events were possibly meropenem-related.
Conclusions:
- Meropenem was well-tolerated in critically ill infants with intra-abdominal infections.
- The majority of infants achieved the defined therapeutic success, supporting its use in this population.
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