Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia.

NCT ID: NCT01683487

Last Updated: 2014-05-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 122 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-05-31

Brief 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

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.

Conditions

Community-acquired Pneumonia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

Observation

Observational study only, no intervention.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Hospital-acquired or ventilator-associated pneumonia
• Patients referred from or transferred to another hospital

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Franzen, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Internal Medicine

Locations

University Hospital Zurich, Division of Internal Medicine

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

MM-CAP

Identifier Type: -

Identifier Source: org_study_id