Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia.

May 26, 2014 updated by: University of Zurich

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

Completed

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:

  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.

Study Type

Observational

Enrollment (Actual)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Division of Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

September 7, 2012

First Submitted That Met QC Criteria

September 7, 2012

First Posted (Estimate)

September 11, 2012

Study Record Updates

Last Update Posted (Estimate)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 26, 2014

Last Verified

May 1, 2014

More Information

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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