The PTN anti-staph trial marks its first enrollment

Dr. Barry Bloom and Ms. Paula Delmore at Wesley Medical Center in Wichita, Kansas, have enrolled the first baby into the Pharmacokinetics of Anti-staphylococcal Antibiotics in Infants trial. The infant—born at 24 weeks gestation and now 52 days old—is receiving clindamycin, one of three anti-staphylococcal antibiotics routinely used in preemies to treat staphylococcal infections.

Seventy percent of late-onset infections in the neonatal intensive care unit are due to staphylococcal species, many of which are methicillin-resistant. Infants with these infections experience long hospitalizations and have an increased risk of septic shock, severe necrotizing pneumonia, and neurodevelopmental impairment, as well as a high risk of death (up to 40%). Rifampin, clindamycin, and ticarcillin-clavulanate are used to fight staphylococcal species, but the correct dosing and safety of these antibiotics has not been established for all infant populations.

This study will measure the levels of rifampin, clindamycin, or ticarcillin-clavulanate in enrolled babies, thereby gauging how the infant body absorbs and distributes the drugs. By understanding these pharmacokinetic properties, we can determine the best doses for treating staphylococcal infections in these vulnerable patients.

The trial 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. To find out more about this study, visit ClinicalTrials.org.