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.”

One Child’s Appreciation for Research

The note below from a PTN study participant serves as a reminder of why we do research in children — to provide the best care to kids. We thank the study staff at Seattle Children’s Hospital (Dr. Joseph Flynn, PI, and Megan Kelton-Rehkopf, study coordinator) for sharing this with the PTN community. This note exemplifies why study coordinators (SCs) are so valuable on the front-line of research studies, as they are often the primary research team member with whom a study participant may interact. Their care, kindness, compassion, and undivided attention are critical to the success of so many research projects.

To Megan Kelton-Rehkopf, study coordinator…

 

PTN hydroxyurea trial enrolls its last patient

On October 23, 2013, the site team at St. Jude Children’s Research Hospital in Memphis, TN, enrolled the last patient into the PTN hydroxyurea study. Overall, 8 sites—Duke University Medical Center, Medical College of Wisconsin, Columbia University Medical Center, Ann & Robert H. Lurie Children’s Hospital of Chicago, Children’s of Alabama, University of Arkansas for Medical Sciences, University of Texas Southwestern, and St. Jude—worked very hard to enroll the 39 patients needed for this study.

Hydroxyurea represents the only major medical breakthrough in sickle cell disease in the past 20 years, and it is the only drug approved by the U.S. Food and Drug Administration (FDA) for use in adults with sickle cell. In spite of the fact that it is not labeled for use in children, hydroxyurea is often used to treat children who exhibit signs of severe sickle cell disease. Recent data suggest that its use in infants with sickle cell is feasible, well-tolerated, and efficacious; however, only limited pharmacokinetic and pharmacodynamic studies of hydroxyurea use in children exist.

This study was designed to better understand how this drug works in children and to confirm its safety profile. Participants were given capsules or a liquid formulation of hydroxyurea, and blood samples were obtained after administration to determine drug concentrations in the body and its elimination. Study results are expected by the first half of 2014.

Evaluation of the Mercy TAPE: performance against the standard for pediatric weight estimation.

Annals of Emergency Medicine • October 2013.

Abdel-Rahman SM, Paul IM, James LP, Lewandowski A; Best Pharmaceuticals for Children Act-Pediatric Trials Network.

We assessed the performance of 2 new devices (2D- and 3D-Mercy TAPE) to implement the Mercy Method for pediatric weight estimation and contrasted their accuracy with the Broselow method. We enrolled children aged 2 months through 16 years in this prospective, multicenter, observational study.

Access article on PubMed.

Acyclovir PK study is complete

The PTN open-label study to describe the pharmacokinetics (PK) of acyclovir in premature infants has concluded, with results recently published in the Pediatric Infectious Diseases Journal.

Acyclovir is a drug used to treat herpes simplex virus (HSV) infections in infants. HSV is a very serious infection in those <6 months of age, often resulting in death or profound mental retardation. Appropriate dosing of acyclovir is known for adults and children but has not been adequately studied in full-term or premature neonates.

This study examined acyclovir levels in the blood of premature and term infants who were placed on the drug to treat a suspected HSV infection, thereby determining the appropriate dose in this vulnerable population. Investigators found that infant maturity as measured by post-menstrual age* is associated with the infant body’s ability to clear the drug; in short, they determined that less frequent dosing is needed in younger infants to achieve optimal therapeutic benefit.

The study was conducted at two sites — Duke University Medical Center in Durham, North Carolina, and Wesley Medical Center in Wichita, Kansas. Site teams headed by Robert Lenfestey (Duke) and Paula Delmore (Wesley) enrolled 32 patients over the 9-month study. Next steps will involve a retrospective analysis of data from infants who received high-dose acyclovir; this information will support proposed label changes submitted to the Food and Drug Administration for use of acyclovir in infants.

* Post-menstrual age is the time elapsed between the first day of the mother’s last menstrual period and the infant’s birth, plus the time elapsed since birth.