Community-acquired PneumoniaNCT01683487
Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia.
An observational study of Community-acquired Pneumonia, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Observation
- Type of treatment
- Surgery or procedure
- How many people
- 122 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2012to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted and treated at the University Hospital of Zurich because of severe community-acquired pneumococcal pneumonia requiring hospilazation.
Inclusion criteria: Patients with community-acquired pneumococcal pneumonia, which was confirmed by
- detection of Streptococcus pneumoniae in blood cultures, tracheal secretion or sputum OR/AND
- positive urinary pneumococcal antigen AND
- presence of cough and presence of one of the following signs/symptoms: new focal chest signs; dyspnoea; tachypnoea; fever AND
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Internal Medicine
Zurich, Canton of Zurich, 8091
About this study
Official title: Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia. Analysis of Risk Factors and Impact on the Outcome.
- 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
Read the 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:
- arthritis, osteoporosis, other chronic pain, bladder problems, and irritable bowel;
- asthma, chronic obstructive pulmonary disease, and allergies;
- back/neck pain, migraine, other chronic pain, and arthritis;
- high blood pressure, high cholesterol, obesity, diabetes, and fatigue;
- cardiovascular disease, diabetes, fatigue, high blood pressure, high cholesterol, and arthritis; and
- irritable bowel, ulcer, heartburn, and other chronic pain.
Time calculation is based upon the moment of emergency room (ER) admission.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Observation
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationProcedure or surgery
Observational study only, no intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortaliy
Mortality during hospitalization because of pneumococcal pneumonia
Measured: From day of admission until discharge or dead
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Franzen, MD, Principal investigator, University Hospital Zurich, Division of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683487
- Sponsor's protocol ID
- MM-CAP
- Status last verified
- May 2014
- First submitted
- 7 Sep 2012
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia. Analysis of Risk Factors and Impact on the Outcome.
- ClinicalTrials.gov ID
- NCT01683487
- Acronym / sponsor ID
- MM-CAP
- Conditions
- Community-acquired Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 11 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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:
- arthritis, osteoporosis, other chronic pain, bladder problems, and irritable bowel;
- asthma, chronic obstructive pulmonary disease, and allergies;
- back/neck pain, migraine, other chronic pain, and arthritis;
- high blood pressure, high cholesterol, obesity, diabetes, and fatigue;
- cardiovascular disease, diabetes, fatigue, high blood pressure, high cholesterol, and arthritis; and
- irritable bowel, ulcer, heartburn, and other chronic pain.
Time calculation is based upon the moment of emergency room (ER) admission.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted and treated at the University Hospital of Zurich because of severe community-acquired pneumococcal pneumonia requiring hospilazation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationObservational study only, no intervention. | Procedure or surgery | – |
Primary outcome
In-hospital mortaliy
Time frame: From day of admission until discharge or dead
Mortality during hospitalization because of pneumococcal pneumonia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Franzen, MD principal investigator
University Hospital Zurich, Division of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-acquired Pneumonia, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortaliy (time frame: From day of admission until discharge or dead). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2014.