Researchers at Vanderbilt University Medical Center (VUMC) are leading a multicenter clinical trial to evaluate whether a shorter course of antibiotics — five days instead of 10 — is effective at treating community-acquired pneumonia (CAP) in children who show improvement after the first few days of taking antibiotics.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring the five-site study, which will use an innovative evaluation method developed by a group of scientists who specialize in antibiotic resistance research.
Physicians at the five institutions will enroll up to 400 children diagnosed with CAP in the clinical trial. Community-acquired pneumonia is a potentially life-threatening lung infection in children, frequently leading to hospitalization. Respiratory viruses and bacterial infections (specifically Streptococcus pneumoniae) are the most common causes of the disease in preschool-age young children. As a result, young children diagnosed with CAP are typically treated with a 10-day course of the antibiotic amoxicillin.
Previous Vanderbilt-led research, however, has shown that respiratory viruses, not bacteria, are the most commonly detected causes of CAP in children.
“In the EPIC study (Etiology of Pneumonia in the Community), which enrolled more than 2,000 children hospitalized with pneumonia in three U.S. cities, we found viruses in more than 70 percent of children, while bacteria were identified in only 15 percent,” said Derek Williams, M.D., MPH, assistant professor of Pediatrics and co-investigator for the current study. “Antibiotics are not effective against viral infections, but it is very difficult to differentiate viral from bacterial causes of pneumonia at the time of diagnosis.”
Researchers have been examining how to reduce overuse and misuse of antibiotics, which is a growing concern in the medical community.
“Pneumonia is an extremely important cause of outpatient visits, ER visits and hospitalizations,” said Buddy Creech, M.D., MPH, associate professor of Pediatrics, director of the Vanderbilt Vaccine Research Program (VVRP) and principal investigator for the multicenter study. “This study will lay the groundwork for potentially treating children with pneumonia for less time (thus reducing side effects) or potentially identifying how to treat only those who are likely to benefit from antibiotics.”
The new clinical study, called SCOUT-CAP (Short Course vs. Standard Course Outpatient Therapy of CAP in Children), will enroll children ages 6-71 months diagnosed with community-acquired pneumonia who were initially treated in outpatient clinics, urgent care facilities and emergency departments and have clinically improved prior to enrollment. The trial is being conducted through the NIAID-funded Vaccine and Treatment Evaluation Units (VTEU) program, in collaboration with the NIAID-funded Antibacterial Resistance Leadership Group (ARLG).
Participating sites include three VTEU program sites (Vanderbilt, Duke University and Cincinnati Children’s Hospital Medical Center) along with Children’s Hospital of Philadelphia and Children’s Hospital of Pittsburgh-University of Pittsburgh.
The trial will use an evaluation method specifically designed to assess the best treatment strategies with a goal of reducing children’s exposure to antibiotics and ultimately reducing the potential for developing resistance to antibiotics. The NIAID-sponsored ARLG, which prioritizes, designs and executes clinical research to reduce the threat of antibiotic resistance, developed the trial method and the study concept. The SCOUT-CAP trial, estimated to end in March 2019, will evaluate short courses of the oral antibiotics amoxicillin, amoxicillin-clavulanate and cefdinir.
As planned, 200 children enrolled in the study will receive the standard 10-day course of antibiotics now suggested, and 200 children will receive the shorter five-day course.