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Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia.

This study is not yet open for participant recruitment.
Verified September 2012 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01683487
First received: September 7, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

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


Condition Intervention Phase
Community-acquired Pneumonia
 Procedure: Observation
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia. Analysis of Risk Factors and Impact on the Outcome.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Observation
    Observational study only, no intervention.
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:

  1. arthritis, osteoporosis, other chronic pain, bladder problems, and irritable bowel;
  2. asthma, chronic obstructive pulmonary disease, and allergies;
  3. back/neck pain, migraine, other chronic pain, and arthritis;
  4. high blood pressure, high cholesterol, obesity, diabetes, and fatigue;
  5. cardiovascular disease, diabetes, fatigue, high blood pressure, high cholesterol, and arthritis; and
  6. irritable bowel, ulcer, heartburn, and other chronic pain.

Time calculation is based upon the moment of emergency room (ER) admission.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted and treated at the University Hospital of Zurich because of severe community-acquired pneumococcal pneumonia requiring hospilazation.

Criteria

Inclusion criteria: Patients with community-acquired pneumococcal pneumonia, which was confirmed by

  1. detection of Streptococcus pneumoniae in blood cultures, tracheal secretion or sputum OR/AND
  2. positive urinary pneumococcal antigen AND
  3. presence of cough and presence of one of the following signs/symptoms: new focal chest signs; dyspnoea; tachypnoea; fever AND
  4. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683487

Contacts
Contact: Daniel Franzen, MD daniel.franzen@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Internal Medicine Not yet recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Daniel Franzen, MD University Hospital Zurich, Division of Internal Medicine
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01683487     History of Changes
Other Study ID Numbers: MM-CAP
Study First Received: September 7, 2012
Last Updated: September 7, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Pneumococcal
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pneumococcal Infections
Streptococcal Infections
 Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013