Condition category
Infections and Infestations
Date applied
01/09/2004
Date assigned
08/09/2004
Last edited
07/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

National Health Service (Spain)

Sponsor details

Sinesio Delgado 4
Madrid
28029
Spain

Sponsor type

Government

Website

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

  1. 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.

Additional files

Editorial Notes