Ampicillin Results-At-A-Glance

Ampicillin, a medicine used to treat infections, is the most commonly used drug in babies born prematurely who are admitted to the hospital. At the same time, practically no one has ever figured out how the drug is processed in newborns. The goal of the “Ampicillin in Infants Study” was to find out how newborns process ampicillin and determine the safest and most effective dose to treat infections.

Caffeine Citrate Results-At-A-Glance

Almost all infants born at less than 29 weeks gestational age develop apnea of prematurity (AOP). Caffeine citrate is often used in the neonatal intensive care unit (NICU) to treat AOP. However, the drug label for caffeine citrate was last updated by the FDA in 1999. This label recommends short-term use of the drug for premature infants 28 – 33 weeks gestational age, but caffeine citrate is frequently used in
infants born earlier. This study was needed to identify the association of caffeine citrate use and safety in infants less than 29 weeks gestational age and to bridge the gap in caffeine citrate’s label recommendations and current clinical practice.

POP01 Results-At-A-Glance

Many drugs that physicians prescribe to children are understudied and many lack dosing recommendations. This lack of information on pediatric drug dosing and safety can put children at risk for side effects and treatment failure when given a drug therapy that is not dosed appropriately.

Meropenem Results-At-A-Glance

Infections in the intestines are common in premature infants younger than three months old. These infections are dangerous, and the infants often die. Meropenem is a medicine used to treat many different kinds of infections. It was approved for use in adults and older children, but until this study no one knew how the medicine affects infants younger than three months old.

Lisinopril Results-At-A-Glance

Lisinopril is approved for treating high blood pressure in adults and children over 6 years old. But the best, safest dose of lisinopril in children under age 6 had never been figured out. High blood pressure is common in children and teens who have had a kidney transplant, but no one knew the correct dose for this group either.

Acyclovir Results At-A-Glance

Infants are at high risk for infections caused by bacteria and viruses. Herpes simplex virus (HSV) is a dangerous infection that can often cause death or mental disability in infants. Acyclovir is a medicine approved by the U.S. Food and Drug Administration (FDA) for HSV but the best and safest dose of acyclovir for infants, particularly premature infants, was not previously known. The “Open-Label Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants” study was conducted in order to learn more about the appropriate level of acyclovir dosing for infants.

A POPS site goes above and beyond

The Lurie Children’s team (from left to right): Rohit Kalra, Brize Morales, Ram Yogev, Laura Fearn, Kathy Rosa, and Mayra Gomez
The Lurie Children’s team (from left to right): Rohit Kalra, Brize Morales, Ram Yogev, Laura Fearn, Kathy Rosa, and Mayra Gomez

For an example of an outstanding PTN site, look no further than Ann & Robert H. Lurie Children’s Hospital of Chicago. The top enrolling site for the POPS study, Lurie Children’s has enrolled 244 patients as of September 22. To put this number into perspective, the second highest enrolling POPS site has recruited 117 patients, and the third highest 99 patients. Lurie Children’s is also a leader in the clindamycin trial, enrolling almost one third of the patients needed to complete the study. A nimble team of 6 individuals makes it all happen, under the direction of Dr. Ram Yogev, site PI and professor in Pediatrics–Infectious Diseases at Northwestern University Feinberg School of Medicine.

Dr. Yogev attributes his site’s success to communication and dedication. Site team members participate in a mandatory weekly meeting to review study progress over the preceding week and to identify and troubleshoot any problems that may have arisen. This combination of accountability and collaboration helps to ensure that everyone keeps invested in the team’s success.

But, Dr. Yogev is careful to note, communication must extend beyond the confines of the site team to ensure optimal conduct of a study. To this end, he devotes a great deal of time nurturing relationships in other departments at his institution to facilitate understanding of study goals and to bank good will with people who can help make reaching those goals possible. Dr. Yogev observes, “You can’t rely on the hierarchy to make things happen; it’s personal relationships that create a willingness to help.”

For example, one study of a drug with a very short half-life required sampling at 3 time points within a half hour. To ensure coverage for those draws, non-study personnel in relevant departments had to be enlisted and reminded to alert the site team of when eligible patients would be available. Such teamwork would be difficult to foster had those individuals not been approached and befriended by Dr. Yogev. “Thanks to this study, I have more friends than I had before,” he jests.

Much of what drives Dr. Yogev to go the extra mile in this regard is the desire to be an example to his team. “If your people see that you are dedicated,” he observes, “they will try to match or even beat that dedication.” In fact, he admits that he is in friendly competition with his study coordinator, Laura Fearn, to be the best at what they do (and she usually wins, he notes). Other team members who routinely go above and beyond include Jannie Stewart (site phlebotomist), Kathy Rosa (regulatory specialist), and Mayra Gomez (data entry coordinator).

When asked about why he decided to become involved with the Pediatric Trial Network, Dr. Yogev highlights the critical lack of knowledge to inform dosing of the vast majority of drugs used in kids. Collaboration between government, academia, and industry, he notes, is a positive way to make crucial changes — “I only wish I had come up with the idea myself!”

The PTN pantoprazole study enrolls its first patient

The PTN study of the effect of obesity on the pharmacokinetics of pantoprazole in children and adolescents has enrolled its first patient. The study team at Arkansas Children’s Hospital (PI Laura James, MD, SC Lee Howard, RN) did the honors.

Obese children are more frequently diagnosed with gastroesophageal reflux disease (GERD) than children of normal weight. Proton pump inhibitors, such as pantoprazole, have become key components in the pharmacological management of GERD in pediatrics. In this multicenter, open-label, single-dose study of pantoprazole, the PTN is examining the pharmacokinetics of the drug in obese children who require treatment with an acid-modifying agent. The data collected will be compared to existing pharmacokinetic data in non-obese subjects.

The study population includes obese male and female children and adolescents, ranging in age from 6–17 years (inclusive) with the diagnosis of GERD. Approximately 40 participants will be enrolled at up to 3 sites. To learn more about this study, visit clinicaltrials.gov.

SCAMP enrolls its first patient

SCAMP—a randomized, multicenter, open-label Safety study of Clindamycin, Ampicillin, Metronidazole, and Piperacillin-tazobactam in infants with complicated intra-abdominal infections—enrolled its first patient over the weekend. The research team at the University of Florida–Jacksonville Shands Medical Center did the honors, led by site principal investigator Mark Hudak and study coordinator Renee Prince.

SCAMP is seeking to determine the safety and efficacy of antibiotics routinely used in infants with these life-threatening infections. Approximately 350 infants will be enrolled at approximately 50 sites. Total length of study participation is 100 days, including 10 days of treatment and up to 90 days of follow-up assessments. To learn more about this study, visit clinicaltrials.gov.