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.

SCAMP takes off

SCAMP is taking off. A randomized, multicenter, open-label safety study of clindamycin, ampicillin, metronidazole, and piperacillin-tazobactam in infants with complicated intra-abdominal infections, SCAMP held its first investigator meeting on 2/28/2014. Twenty-five sites have been selected to date, with an additional 25 sites in the U.S. still to be recruited.

To learn more about SCAMP, visit clinicaltrials.gov. If your site is interested in participating in the study, please contact Benjamin Lee at benjamin.lee@dm.duke.edu.

Methadone study enrolls first patient

On January 10, 2014, the site team at the Medical University of South Carolina enrolled the first patient into the “Pharmacokinetics of Multiple-dose Methadone in Children” study. Andrew Atz, MD, principal investigator, Hibah Al Nasiri, study coordinator, and Patricia Infinger, research manager, oversee the team at this institution.

This multicenter study will determine the pharmacokinetics of enteral methadone in children treated for opiate withdrawal. Critically ill children routinely receive opioids for analgesia and sedation to reduce pain and stress, facilitate ventilation, and avoid secondary complications. Continuous infusions of opioids can result in tolerance, however, frequently leading to withdrawal symptoms if the drugs are discontinued abruptly. Opioid withdrawal is a major problem in the pediatric intensive care unit, where it is estimated to occur in up to 57% of patients.

Fortunately, gradual opioid tapering is possible with drugs such as methadone, which can be substituted for narcotic infusions during the weaning process to prevent withdrawal symptoms. Methadone is commonly prescribed to hospitalized children, particularly in younger age groups. We know that methadone levels in the blood vary dramatically in adults, especially after oral administration. That is likely to be the case in children, but there are virtually no studies to guide dosing in this younger population.

The study will enroll children aged >90 days to <18 years of age who are prescribed methadone per routine care. As many as 36 participants will be enrolled at up to 5 sites. Visit clinicaltrials.gov for more information.

BPCA study leads to pediatric label change

A Duke- and Stanford-led study has resulted in key changes being made to the label of a drug used routinely in children to control blood pressure in the perioperative environment. Scott Schulman, MD, of the Duke University Medical Center, in collaboration with co-principal investigator Gregory Hammer, MD, of the Stanford University Medical Center, oversaw this phase II, multicenter, randomized, double-blind, parallel group, dose-ranging, effect-controlled study to determine the dose-response relationship of sodium nitroprusside in pediatric subjects. The study was sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development under the Best Pharmaceuticals for Children Act. The revised drug label may be viewed at Daily Med.

“This is the first labeling change of an off-patent molecule in children under the BPCA mechanism based on a very challenging trial,” noted Danny Benjamin, MD, PhD, principal investigator for the Pediatric Trials Network (PTN), an NIH-supported research network conducting trials to improve drug labeling for children. “These BPCA trials, now led by the Duke Clinical Research Institute’s PTN, are typically unique in design and require substantial operational expertise. The team should be proud of the accomplishment.”