Pneumonia Clinical Trial
— PIVVOTOfficial title:
Comparative Effectiveness of Intravenous v. Oral Antibiotic Therapy for Serious Bacterial Infections
NCT number | NCT02311452 |
Other study ID # | 526 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | December 4, 2014 |
Last updated | December 5, 2014 |
Start date | January 2009 |
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.
Status | Completed |
Enrollment | 15000 |
Est. completion date | |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Months to 17 Years |
Eligibility |
Inclusion Criteria: 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: - Acute Osteomyelitis (730.01-730.09) OR - Unspecified Osteomyelitis (730.2-730.29) Exclusion Criteria: 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.) |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | Children's Hospital Boston, Children's Hospital Medical Center, Cincinnati, University of Utah |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | PICC complication | Revisit to the ED or a rehospitalization for fever evaluation, infection at the site of the PICC insertion, blood stream infection, sepsis, and thrombosis, breakage, repair, adjustment, manipulation, or removal of the PICC line with or without insertion of a new line. | 6 months | Yes |
Secondary | Adverse Drug Reaction | Return to the ED or a rehospitalization for an adverse drug reaction (defined as vomiting and/or diarrhea, dehydration, Clostridium difficile infection, allergic reaction, urticaria, anaphylaxis, drug- induced neutropenia, acute kidney injury, Stevens-Johnson syndrome, erythema multiforme, or other). | 6 months | Yes |
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