The POPS study is moving full steam ahead. In September 2012, the study received additional funding from the National Institute of Child Health and Human Development to effectively double in size, increasing the number of patients enrolled from 500 to ~1000 and doubling the number of participating sites from ~15 to ~30.
And the new year has brought new momentum. In January, the study added 7 new drugs of interest to the 12 already being studied. To date, 375 patients are enrolled, and recruitment will continue into 2014 unless the targeted enrollment is met sooner. Analysis of one drug of interest – ampicillin – is already underway.
POPS (Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care) is designed to characterize the pharmacokinetics of drugs that lack specific dosing recommendations and safety data in children. Many drugs prescribed in the United States lack such information for kids, and, unfortunately, these knowledge gaps place young people at risk for adverse events and therapeutic failure.
In POPS, the drugs of interest are being administered to children by their treating physicians according to local standards of care. The only study procedure involves biological sample collection during the time of drug administration. Participants are followed for up to 90 days. To find out whether there’s a participating site near you, visit clinicaltrials.gov.