Comparative Effectiveness of Intravenous v. Oral Antibiotic Therapy for Serious Bacterial Infections
Condition: Osteomyelitis; Pneumonia; Appendicitis
MeSH terms: Appendicitis; Bacterial Infections; Osteomyelitis
Study type: Observational

Summary: 
      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 the investigator 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, the investigators 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.
    

Detailed description: 
      Background: When clinicians want to prescribe prolonged antibiotic therapy for children who
      have been hospitalized with a serious bacterial infection they have two options: (1)
      discontinue the intravenous antibiotics and discharge the child to receive a prolonged course
      of oral antibiotics at home; or (2) insert a central venous catheter (usually a peripherally
      inserted central catheter (PICC)), train the parents in care of the PICC and administration
      of intravenous antibiotics, and discharge the child to receive a prolonged course of
      intravenous antibiotics via the central venous catheter at home. These two options have major
      implications for the overall experience of the child and their caregiver, but there is a
      paucity of evidence on their comparative effectiveness to help clinicians, patients, and
      their caregivers make an informed choice.

      Objectives: In this proposal the investigators outline a series of projects to compare oral
      antibiotics vs. intravenous antibiotics delivered via a central venous catheter in children
      who require prolonged (at least 1 week) home antibiotic therapy after hospitalization for
      three different serious bacterial infections: perforated appendicitis, complicated pneumonia,
      and osteomyelitis.

      Methods: To compare the clinical effectiveness of these two treatment options, the
      investigators will conduct three separate retrospective comparative effectiveness studies for
      each of these diseases using detailed electronic data on diagnoses, procedures, laboratory
      tests, and orders for drugs and devices supplemented by limited chart review from 43 free
      standing children's hospitals that are members of the Children's Hospital Association (CHA)
      (study years 2009-2011, total sample size will exceed 15,000 children). The primary outcome
      will be rehospitalization for treatment failure. The investigators will use conventional and
      propensity-score based methods, including matching, to estimate and compare the effect of the
      two treatment options on patient outcomes. These comparisons will have the goal of asking
      about the effect of therapy as if the patients had been randomized to one of the two
      treatment options.
    

Intervention name(s): Peripherally Inserted Central Catheter (PICC)
Intervention type(s): Device
Intervention description(s): Post-discharge antibiotics delivered via a PICC line.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children hospitalized for acute osteomyelitis, complicated pneumonia, or complicated
        appendicitis, and discharged to complete a course of antibiotics.