Usefulness of a three-step guideline to reduce length of hospital stay for patients with community-acquired pneumonia: a randomised controlled trial
ISRCTN | ISRCTN17875607 |
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DOI | https://doi.org/10.1186/ISRCTN17875607 |
Secondary identifying numbers | FIS 040139 |
- Submission date
- 18/04/2006
- Registration date
- 17/05/2006
- Last edited
- 06/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jordi Carratala
Scientific
Scientific
Infectious Disease Service
Hospital Universitari de Bellvitge
Feixa Llarga s/n
L´Hospitalet
Barcelona
08907
Spain
Phone | +34 (0)93 260 76 25 |
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jcarratala@wanadoo.es |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | Usefulness of a three-step guideline to reduce length of hospital stay for patients with community-acquired pneumonia: a randomised controlled trial |
Study objectives | The implementation of a three-step guideline would be effective and safe in reducing length of stay for hospitalized patients with community-acquired pneumonia |
Ethics approval(s) | Approved by the Ethics Committee of the University of Bellvitge (Comite Etic d´Investigació de l´Hospital Universitari de Bellvitge), July 2004, reference number: 05/FIS-008 |
Health condition(s) or problem(s) studied | Community-acquired pneumonia |
Intervention | Patients will be randomly assigned to one of two groups: 1. Use of a three-step guideline, including early mobilization, and pre-defined criteria for switch antibiotic therapy and hospital discharge 2. Control group (conventional management) |
Intervention type | Other |
Primary outcome measure | Length of hospital stay |
Secondary outcome measures | 1. Time to switch 2. Readmission (<30 days) 3. Overall mortality (<30 days) 4. Satisfaction with care |
Overall study start date | 24/04/2006 |
Completion date | 31/12/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 376 |
Total final enrolment | 401 |
Key inclusion criteria | Immunocompetent adults (aged >18 years) who have received a diagnosis of community-acquired pneumonia in the emergency department and are admitted to the hospital |
Key exclusion criteria | 1. Severe immunosuppression (neutropenia, transplantation, human immunodeficiency virus [HIV] infection) 2. Imminent death 3. Intensive care unit (ICU) admission 4. Shock 5. Complicated pleural effusion 6. Aspiration pneumonia 7. Social problem (homelessness) 8. Not able to drink and eat 9. Absence of written informed consent |
Date of first enrolment | 24/04/2006 |
Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Spain
Study participating centre
Infectious Disease Service
Barcelona
08907
Spain
08907
Spain
Sponsor information
Spanish National Health Service (Fondo de Investigación Sanitaria)
Government
Government
Sinesio Delgado 4
Madrid
28029
Spain
Funders
Funder type
Government
Investigation of Sanitary Funding (Fondo de Investivación Sanitaria) IDIBELL
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 25/06/2012 | Yes | No |
Editorial Notes
06/01/2021: Total final enrolment added.