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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