Status:
COMPLETED
Comparative Effectiveness of Intravenous v. Oral Antibiotic Therapy for Serious Bacterial Infections
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
University of Utah
Boston Children's Hospital
Conditions:
Osteomyelitis
Pneumonia
Eligibility:
All Genders
2-17 years
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 ruptur...
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 intrave...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15000 Patients enrolled
Trial Details
Trial ID
NCT02311452
Start Date
January 1 2009
Last Update
December 8 2014
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