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Comparative effectiveness of intravenous versus oral antibiotic therapy for serious bacterial infections
Investigator (PI): Keren, Ron
Performing Organization (PO): (Current): Children's Hospital of Philadelphia, Division of General Pediatrics / (215) 590-2164
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2013
Final Year: 2018
Record Source/Award ID: PCORI/526
Funding: Total Award Amount: $1,415,713
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Some children get serious bacterial infections that require hospitalization and then a long course of antibiotics to completely treat the infection. Examples of these serious infections include ruptured appendicitis (when the appendix gets inflamed and bursts, releasing bacteria into the abdomen), complicated pneumonia (when an infected pocket of pus forms either in the lung or between the lung and chest wall), and osteomyelitis (an infection of the bone). To extend the duration of antibiotic therapy after discharge from the hospital, doctors will often insert a long catheter called a PICC line in the child's vein, which can stay in the body for several weeks. However, PICC lines require a fair amount of maintenance and training of caregivers in their use, require children to restrict their activities, and can lead to serious complications, such as blood stream infections and clots. An alternative to PICC lines is extending the duration of antibiotic therapy with oral antibiotics (pills or syrup) that achieve high levels of medicine in the blood and do not have the extra work, inconvenience, and risks of PICC lines. Unfortunately, there are very few high-quality studies that have demonstrated that oral antibiotics are just as good as intravenous antibiotics delivered via a PICC line, and so many doctors still recommend the PICC line treatment option. Also, no studies have been done to compare the impact of these two treatment options on the quality of life of the child and their caregivers. In this proposal we outline a series of projects to compare oral antibiotics vs. intravenous antibiotics delivered via a PICC line in children who require prolonged (at least 1 week) home antibiotic therapy after hospitalization for three different serious bacterial infections: ruptured appendicitis, complicated pneumonia, and osteomyelitis. To see whether oral antibiotics are just as good as PICC lines, we will use data collected from over 15,000 children with one of these three infections who were hospitalized at one of 43 US children's hospitals during the years 2009-2011, and determine whether PICC lines resulted in fewer rehospitalizations for treatment failure than oral therapy. To see what impact the choice of treatment option has on patient and caregiver quality of life and ability to take the medicine, we will spend 18 months surveying at least 1000 patients (and their caregivers) who are discharged from four large children's hospitals with either prolonged oral or intravenous therapy after hospitalization for treatment of ruptured appendicitis, complicated pneumonia, or osteomyelitis. In all our comparisons, we will use special statistics to make sure that we are comparing similar patients in the two treatment groups so that these are fair comparisons.
MeSH Terms:
  • * Administration, Intravenous
  • * Administration, Oral
  • Anti-Bacterial Agents /*administration & dosage
  • Appendicitis /drug therapy
  • Bacterial Infections /*drug therapy
  • Caregivers
  • Catheterization, Central Venous
  • Catheterization, Peripheral
  • Child
  • Comparative Effectiveness Research
  • Hospitals, Pediatric
  • Humans
  • Osteomyelitis /drug therapy
  • Pneumonia /drug therapy
  • Quality of Life
  • Treatment Outcome
  • United States
Country: United States
State: Pennsylvania
Zip Code: 19104
UI: 20143337
CTgovId: NCT02311452
Project Status: Completed
Record History: ('2018: Project extended to 2018. 2017: Project extended to 2017.',)