Usefulness of a three-step guideline to reduce length of hospital stay for patients with community-acquired pneumonia: a randomised controlled trial
| ISRCTN | ISRCTN17875607 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17875607 |
| Protocol serial number | FIS 040139 |
| Sponsor | Spanish National Health Service (Fondo de Investigación Sanitaria) |
| Funder | Investigation of Sanitary Funding (Fondo de Investivación Sanitaria) IDIBELL |
- 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 |
|---|---|
| jcarratala@wanadoo.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Length of hospital stay |
| Key secondary outcome measure(s) |
1. Time to switch |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
