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Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01683487
First received: September 7, 2012
Last updated: May 26, 2014
Last verified: May 2014
  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:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • In-hospital mortaliy [ Time Frame: From day of admission until discharge or dead ] [ Designated as safety issue: No ]
    Mortality during hospitalization because of pneumococcal pneumonia


Enrollment: 122
Study Start Date: October 2012
Study Completion Date: May 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683487

Locations
Switzerland
University Hospital Zurich, Division of Internal Medicine
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: May 26, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Pneumococcal
Bacterial Infections
Gram-Positive Bacterial Infections
Lung Diseases
Pneumococcal Infections
Pneumonia, Bacterial
Respiratory Tract Diseases
Respiratory Tract Infections
Streptococcal Infections

ClinicalTrials.gov processed this record on November 24, 2014