Comparative Effectiveness of Intravenous v. Oral Antibiotic Therapy for Serious Bacterial Infections
PIVVOT
1 other identifier
observational
15,000
0 countries
N/A
Brief 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.
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participants targeted
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 4, 2014
CompletedFirst Posted
Study publicly available on registry
December 8, 2014
CompletedDecember 8, 2014
December 1, 2014
3.9 years
December 4, 2014
December 5, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment Failure
Revisit to the ED or a rehospitalization for a change in the antibiotic prescribed or its dosage, prolongation of antibiotic therapy, conversion from the oral to the PICC route.
6 months
Secondary Outcomes (2)
PICC complication
6 months
Adverse Drug Reaction
6 months
Study Arms (3)
Acute Osteomyelitis
Complicated Pneumonia
Complicated Appendicitis
Interventions
Post-discharge antibiotics delivered via a PICC line.
Eligibility Criteria
Children hospitalized for acute osteomyelitis, complicated pneumonia, or complicated appendicitis, and discharged to complete a course of antibiotics.
You may qualify if:
- Complicated Pneumonia
- Age 2 months-17 years
- ICD-9 CM codes in any of the 21 diagnosis fields:
- Pneumonia (480.x-483.x, 485.x-487.x) AND
- Pleural effusion (510.0, 510.9, 511.0, 511.1, 511.9) AND
- Billing charge for antibiotics on the first day of hospitalization AND
- Primary diagnosis must be either pneumonia or pleural effusion
- Complicated Appendicitis
- Ages 3 years to 17 years
- ICD-9-CM principal diagnosis of appendicitis (540.0, 540.1, 540.0) AND
- ICD-9-CM principal procedure codes of non-incidental appendectomy (470.9, 470.1) AND
- At least 3 unique postop days of antibiotics
- Acute Osteomyelitis
- Ages 2 months- 17 years
- ICD-9-CM codes in any of the 21 diagnosis fields:
- +2 more criteria
You may not qualify if:
- Complicated Pneumonia • Patients without ED charge (excludes transfers from OSH)
- Complicated Appendicitis
- Patients without ED charge (excludes transfers from OSH and possibility of interval appendectomy that is misclassified)
- Acute Osteomyelitis
- Hospitalization 6 months prior to index admission for chronic osteomyelitis (ICD-9-CM code 730.1)
- ICD9-CM codes for potential confounding comorbidities (e.g. cellulitis, pyogenic arthritis, sacroiliitis, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital of Philadelphialead
- University of Utahcollaborator
- Boston Children's Hospitalcollaborator
- Children's Hospital Medical Center, Cincinnaticollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice President of Quality
Study Record Dates
First Submitted
December 4, 2014
First Posted
December 8, 2014
Study Start
January 1, 2009
Primary Completion
December 1, 2012
Last Updated
December 8, 2014
Record last verified: 2014-12