Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Spanish National Health Service (Fondo de Investigación Sanitaria)

Sponsor details

Sinesio Delgado 4
Madrid
28029
Spain

Sponsor type

Government

Website

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

  1. 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.

Editorial Notes