Contact information
Type
Scientific
Primary contact
Dr Jordi Carratala
ORCID ID
Contact details
Hospital Universitari de Bellvitge
Feixa Llarga s/n
L´Hospitalet
Barcelona
08907
Spain
+34 932607625
jcarratala@wanadoo.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FIS 00/0438
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Community-Acquired Pneumonia
Intervention
Patients were randomly assigned to outpatient care or hospitalisation, and received oral or switch therapy with levofloxacin, respectively.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2000
Overall trial end date
31/10/2002
Reason abandoned
Eligibility
Participant inclusion criteria
224 immunocompetent adults in risk classes II or III (Pneumonia Severity Index ≤90 points), without extenuating conditions diagnosed with community-acquired pneumonia in the emergency department.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
224
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2000
Recruitment end date
31/10/2002
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital Universitari de Bellvitge
Barcelona
08907
Spain
Funders
Funder type
Industry
Funder name
Fondo de Investigacion Sanitaria (FIS) (Spain) - ref: 00/0438
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Aventis (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Barcelona (Spain) - Fellowship grant
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
Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=15684204
Publication citations
-
Results
Carratalà J, Fernández-Sabé N, Ortega L, Castellsagué X, Rosón B, Dorca J, Fernández-Agüera A, Verdaguer R, Martínez J, Manresa F, Gudiol F, Outpatient care compared with hospitalization for community-acquired pneumonia: a randomized trial in low-risk patients., Ann. Intern. Med., 2005, 142, 3, 165-172.