Contact information
Type
Scientific
Primary contact
Dr Jordi Carratala
ORCID ID
Contact details
Infectious Disease Service
Hospital Universitari de Bellvitge
Feixa Llarga s/n
L´Hospitalet
Barcelona
08907
Spain
+34 (0)93 260 76 25
jcarratala@wanadoo.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FIS 040139
Study information
Scientific title
Acronym
Study hypothesis
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
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
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
24/04/2006
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
376
Participant 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
Recruitment start date
24/04/2006
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Spain
Trial participating centre
Infectious Disease Service
Barcelona
08907
Spain
Funders
Funder type
Government
Funder name
Investigation of Sanitary Funding (Fondo de Investivación Sanitaria) IDIBELL
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 abstract in http://www.ncbi.nlm.nih.gov/pubmed/22732747
Publication citations
-
Abstract
Carratalà J, Garcia-Vidal C, Ortega L, Fernández-Sabé N, Clemente M, Albero G, López M, Castellsagué X, Dorca J, Verdaguer R, Martínez-Montauti J, Manresa F, Gudiol F, Effect of a 3-step critical pathway to reduce duration of intravenous antibiotic therapy and length of stay in community-acquired pneumonia: a randomized controlled trial., Arch. Intern. Med., 2012, 172, 12, 922-928, doi: 10.1001/archinternmed.2012.1690.