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| Sponsors and Collaborators: |
UMC Utrecht Dutch Health Care Insurance Board |
|---|---|
| Information provided by: | UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT00273676 |
Purpose
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 antibiotics. Efficacy of this treatment is compared to a standard course of 7 days of intravenous antibiotics, which treatment is assigned to the other half of patients. Outcomes measured are clinical cure and costs.
| Condition | Intervention | Phase |
|---|---|---|
|
Severe Communtity-Acquired Pneumonia |
Procedure: Conversion to oral antibiotic treatment after 3 days of intravenous antibiotic treatment |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Costs and Effects of Early Switch of Intravenous to Oral Antibiotics in Severe Community-Acquired Pneumonia: a Multicenter Randomized Trial |
| Estimated Enrollment: | 500 |
| Study Start Date: | July 2000 |
| Estimated Study Completion Date: | March 2004 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 Criteria:
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.
-
Contacts and Locations| Netherlands | |
| University Medical Center | |
| Utrecht, Netherlands, 3508 GA | |
| Principal Investigator: | Andy IM Hoepelman, Professor of Medicine | University Medical Center, Department of Internal Medicine and Infectious Diseases, Utrecht, The Netherlands |
More Information
| Study ID Numbers: | OG 99-64 |
| Study First Received: | January 5, 2006 |
| Last Updated: | January 5, 2006 |
| ClinicalTrials.gov Identifier: | NCT00273676 History of Changes |
| Health Authority: | Netherlands: The Health Care Insurance Board |
|
Community-acquired pneumonia Treatment Antibiotics |
|
Anti-Infective Agents Anti-Bacterial Agents Respiratory Tract Infections |
Respiratory Tract Diseases Lung Diseases Pneumonia |
|
Anti-Infective Agents Anti-Bacterial Agents Respiratory Tract Infections Respiratory Tract Diseases |
Therapeutic Uses Lung Diseases Pharmacologic Actions Pneumonia |
