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Study on Costs and Safety of Early Conversion From Intravenous to Oral Antibiotic Treatment in Patients With Severe Community-Acquired Pneumonia

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ClinicalTrials.gov Identifier: NCT00273676
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : January 9, 2006
Sponsor:
Collaborator:
Dutch Health Care Insurance Board
Information provided by:
UMC Utrecht

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 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 or disease Intervention/treatment Phase
Severe Communtity-Acquired Pneumonia Procedure: Conversion to oral antibiotic treatment after 3 days of intravenous antibiotic treatment Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Costs and Effects of Early Switch of Intravenous to Oral Antibiotics in Severe Community-Acquired Pneumonia: a Multicenter Randomized Trial
Study Start Date : July 2000
Study Completion Date : March 2004

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Primary Outcome Measures :
  1. Clinical cure at day 28 of the study

Secondary Outcome Measures :
  1. Costs for treatment both inside and outside the hospital
  2. Quality of life


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273676


Locations
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Netherlands
University Medical Center
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
Dutch Health Care Insurance Board
Investigators
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Principal Investigator: Andy IM Hoepelman, Professor of Medicine University Medical Center, Department of Internal Medicine and Infectious Diseases, Utrecht, The Netherlands
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00273676    
Other Study ID Numbers: OG 99-64
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: January 9, 2006
Last Verified: January 2006
Keywords provided by UMC Utrecht:
Community-acquired pneumonia
Treatment
Antibiotics
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents