This study will evaluate the pharmacokinetics and safety of 3 antistaphylococcal antibiotics in term and premature infants. There will be up to 32 infants enrolled for each antibiotic. The study will be open to children of both sexes and all racial and ethnic groups. The study is expected to last approximately 18 months; each infant in the study will participate for up to 10 days.
Matthew M. Laughon, MD, MPH, of the University of North Carolina at Chapel Hill, discusses the anti-staphylococcal mini-trials.
In premature infants, 70% of late-onset infection in the neonatal intensive care unit is due to staphylococcal species. The majority of coagulase-negative Staphylococcus isolates (95%) and Staphylococcus aureus isolates (40%) are methicillin-resistant. Infants with these infections have lengthy hospitalizations and an increased risk of septic shock, severe necrotizing pneumonia, and neurodevelopmental impairment, as well as a high risk of mortality (up to 40%). Rifampin, clindamycin, and ticarcillin-clavulanate all have activity against staphylococcal species. However, the correct dosing and safety of these antibiotics has not been established in all infant populations.
This protocol will determine the pharmacokinetics of rifampin, clindamycin, and ticarcillin-clavulanate in term and premature infants. We will measure the levels of each antibiotic in each infant, thereby helping to determine the best dose of these drugs to treat staphylococcal infections in these patients. It is likely that the drugs behave differently in premature infants than they do in older children and adults due to the immaturity of their metabolic and kidney pathways; thus, identifying the correct dosages represents a critical public health need. We will enroll up to 32 infants for each drug. The drugs will be given over 2–4 days, and the infants will be monitored for another 7 days for any drug side effects.
Enrollment closed; analysis ongoing
Matthew Laughon, MD, MPH
University of North Carolina
Chapel Hill, NC
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