Status:
COMPLETED
Study on Costs and Safety of Early Conversion From Intravenous to Oral Antibiotic Treatment in Patients With Severe Community-Acquired Pneumonia
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Dutch Health Care Insurance Board
Conditions:
Severe Communtity-Acquired Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Patients with severe community-acquired pneumonia are included Half of the patients are treated with a 3 day course of intravenous antibiotics, followed, when clinical stable, by a course of oral anti...
Detailed Description
Study design A multi-center, randomized open label clinical trial was performed in 2 university medical centers and 5 teaching hospitals in the Netherlands. The study was approved by the medical ethic...
Eligibility Criteria
Inclusion
- Adult patients (age 18 or above) with severe CAP admitted to general hospital wards were eligible for inclusion in the study. Pneumonia was defined as a new or progressive infiltrate on a chest X-ray plus at least two of the following criteria: cough, sputum production, rectal temperature \> 38oC or \< 36.1oC, auscultatory findings consistent with pneumonia, leucocytosis (\>10.000/mm3, or \>15% bands), C-reactive protein \> 3 times the upper limit of normal, positive blood culture or positive culture of pleural fluid. 21 Severe pneumonia was defined as Fine class IV or V or fulfilling the ATS-criteria for severe community-acquired pneumonia
Exclusion
- Patients with cystic fibrosis, a history of colonization with Gram negative bacteria due to structural damage to the respiratory tract, malfunction of the digestive tract, life expectancy of less than 1 month due to underlying diseases, infections other than pneumonia needing antibiotic treatment, severe immunosuppression (neutropenia (\<0,5 x 109 / l) or a CD4 count \< 200 / mm3) and needing mechanical ventilation in an intensive care unit were excluded.
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Key Trial Info
Start Date :
July 1 2000
Trial Type :
INTERVENTIONAL
End Date :
March 1 2004
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00273676
Start Date
July 1 2000
End Date
March 1 2004
Last Update
January 9 2006
Active Locations (1)
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1
University Medical Center
Utrecht, Utrecht, Netherlands, 3508 GA