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 |
| Protocol serial number | FIS 00/0438 |
| Sponsor | National Health Service (Spain) |
| Funders | Fondo de Investigacion Sanitaria (FIS) (Spain) - ref: 00/0438, Aventis (Spain), University of Barcelona (Spain) - Fellowship grant |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/10/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
