Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia.

Community-acquired Pneumonia Clinical Trial

Official title:

Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia. Analysis of Risk Factors and Impact on the Outcome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683487
• Other study ID #: MM-CAP
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2012
• Last updated: May 26, 2014
• Start date: October 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia
• Pneumonia, Pneumococcal

Intervention

Procedure:
• Observation
Observational study only, no intervention.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Internal Medicine	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortaliy	Mortality during hospitalization because of pneumococcal pneumonia	From day of admission until discharge or dead	No