- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01683487
Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia.
Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia. Analysis of Risk Factors and Impact on the Outcome.
I. To investigate time measurement from emergency room admission to first antibiotic administration.
II. To evaluate risk factors for prolonged time to first antibiotic administration.
III. To correlate time measurement with Charlson comorbidity index and multimorbidity patterns.
IV. To investigate the impact of a delayed time to first antibiotic administration on the outcome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this retrospective cohort study, we plan to include all patients presenting with a community-acquired pneumococcal pneumonia at the University Hospital of Zurich between January 1, 2006 and June 30, 2012 (6½ years). The patients will be identified either with one or more blood culture pairs positive for S. pneumoniae or with a positive pneumococcal urine antigen assay in combination with the clinical diagnosis of CAP, which was based on the presence of select clinical features (e.g., cough, fever, sputum production, and pleuritic chest pain) and is supported by imaging of the lung, usually by chest radiography according to Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of CAP in adults [11].
CAP is not considered if the patient is discharged from a hospital less than 7 days before the current hospital admission, if the first blood culture or urinary antigen assay is obtained more than 1 week after hospital admission, or if the patient has no clinical diagnosis of CAP at the time of admission. Patients referred from or transferred to another hospital are excluded.
After identification of eligible patients upon microbiological results, medical records are reviewed using a standardized data collection questionnaire. Comorbidity is determined using the Charlson comorbidity index [10]. Additionally, all patients are classified according to the multimorbidity patterns proposed by Holden et al. [12]. These are:
- arthritis, osteoporosis, other chronic pain, bladder problems, and irritable bowel;
- asthma, chronic obstructive pulmonary disease, and allergies;
- back/neck pain, migraine, other chronic pain, and arthritis;
- high blood pressure, high cholesterol, obesity, diabetes, and fatigue;
- cardiovascular disease, diabetes, fatigue, high blood pressure, high cholesterol, and arthritis; and
- irritable bowel, ulcer, heartburn, and other chronic pain.
Time calculation is based upon the moment of emergency room (ER) admission.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
ZH
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Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Division of Internal Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria: Patients with community-acquired pneumococcal pneumonia, which was confirmed by
- detection of Streptococcus pneumoniae in blood cultures, tracheal secretion or sputum OR/AND
- positive urinary pneumococcal antigen AND
- presence of cough and presence of one of the following signs/symptoms: new focal chest signs; dyspnoea; tachypnoea; fever AND
- radiologic signs of pneumonia
Exclusion criteria: - Pneumonia of other cause (e.g. non-pneumococcal pneumonia)
- Hospital-acquired or ventilator-associated pneumonia
- Patients referred from or transferred to another hospital
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
In-hospital mortaliy
Time Frame: From day of admission until discharge or dead
|
Mortality during hospitalization because of pneumococcal pneumonia
|
From day of admission until discharge or dead
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MM-CAP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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