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
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

Infectious Disease Service
Hospital Universitari de Bellvitge
Feixa Llarga s/n
L´Hospitalet
Barcelona
08907
Spain

Phone +34 (0)93 260 76 25
Email jcarratala@wanadoo.es

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleUsefulness of a three-step guideline to reduce length of hospital stay for patients with community-acquired pneumonia: a randomised controlled trial
Study objectivesThe 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) studiedCommunity-acquired pneumonia
InterventionPatients 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 typeOther
Primary outcome measureLength of hospital stay
Secondary outcome measures1. Time to switch
2. Readmission (<30 days)
3. Overall mortality (<30 days)
4. Satisfaction with care
Overall study start date24/04/2006
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants376
Total final enrolment401
Key inclusion criteriaImmunocompetent 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 criteria1. 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 enrolment24/04/2006
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • Spain

Study participating centre

Infectious Disease Service
Barcelona
08907
Spain

Sponsor information

Spanish National Health Service (Fondo de Investigación Sanitaria)
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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.