Outpatient care compared with hospitalisation in low-risk patients with community-acquired pneumonia: a randomised trial
| ISRCTN | ISRCTN41238928 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41238928 |
| Secondary identifying numbers | FIS 00/0438 |
- Submission date
- 01/09/2004
- Registration date
- 08/09/2004
- Last edited
- 07/08/2007
- 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
Scientific
Hospital Universitari de Bellvitge
Feixa Llarga s/n
L´Hospitalet
Barcelona
08907
Spain
| Phone | +34 932607625 |
|---|---|
| jcarratala@wanadoo.es |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2000 |
| Completion date | 31/10/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 224 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2000 |
| Date of final enrolment | 31/10/2002 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital Universitari de Bellvitge
Barcelona
08907
Spain
08907
Spain
Sponsor information
National Health Service (Spain)
Government
Government
Sinesio Delgado 4
Madrid
28029
Spain
"ROR" |
https://ror.org/04t4b6y41 |
|---|
Funders
Funder type
Industry
Fondo de Investigacion Sanitaria (FIS) (Spain) - ref: 00/0438
No information available
Aventis (Spain)
No information available
University of Barcelona (Spain) - Fellowship grant
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/02/2005 | Yes | No |
