Procalcitonin guided reduction of the duration of antibiotic therapy in Community Acquired Pneumonia
| ISRCTN | ISRCTN04176397 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04176397 |
| Protocol serial number | EKBB 232/03 |
| Sponsor | University Hospital Basel (Switzerland) |
| Funders | University Hospital Basel (Switzerland):, 1. Clinic of Pulmonary Medicine, 2. Clinic of Endocrinology, 3. Emergency Unit, 4. Department of Internal Medicine, 5. Department of Central Laboratories (infrastructure), BRAHMS AG (Germany) - assay material |
- Submission date
- 18/01/2005
- Registration date
- 15/02/2005
- Last edited
- 19/11/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Beat Muller
Scientific
Scientific
University Hospital
Petersgraben 4
Basel
4031
Switzerland
| Phone | +41 (0)61 265 2525 |
|---|---|
| Happy.Mueller@unibas.ch |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | ProCAP-Study/ProResp II-Study |
| Study objectives | In patients with Community Acquired Pneumonia (CAP), guidelines recommend antibiotic treatment for 7 to 21 days. Procalcitonin is elevated in bacterial infections, and its dynamics have prognostic implications. Objective: To assess procalcitonin guidance for the initiation and duration of antibiotic therapy in community-acquired pneumonia. Hypothesis: Procalcitonin guidance could significantly shorten antibiotic duration with a similar clinical and laboratory outcome. |
| Ethics approval(s) | The study was approved by the institutional review board of University Hospital Basel. Written, informed consent was obtained from all included patients or their legal representatives. |
| Health condition(s) or problem(s) studied | Community Acquired Pneumonia (CAP) |
| Intervention | Control group: Receive antibiotics according to usual practice. Intervention group: In the procalcitonin group, antibiotic treatment was based on serum procalcitonin concentrations as follows: 1. Strongly discouraged: less than 0.1 µg/L 2. Discouraged: less than 0.25 µg/L 3. Encouraged: greater than 0.25 µg/L 4. Strongly encouraged: greater than 0.5 µg/L Reevaluation of the clinical status and measurement of serum procalcitonin levels was recommended after 6 - 24 hours in all patients from whom antibiotics were withheld. Procalcitonin levels were reassessed after 4, 6, and 8 days. Antibiotics were discontinued on the basis of the procalcitonin cutoffs defined above. In patients with very high procalcitonin values on admission (e.g., greater than 10 µg/L), discontinuation of antibiotics was encouraged if levels decreased to levels less than 10% of the initial value (e.g., 1 µg/L, instead of less than 0.25 µg/L). |
| Intervention type | Other |
| Primary outcome measure(s) |
Total antibiotic use, recorded on days 4, 6, and 8 and at follow-up after 6 weeks. |
| Key secondary outcome measure(s) |
Measures of laboratory and clinical outcomes, recorded on days 4, 6, and 8 and at follow-up after 6 weeks. |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 250 |
| Key inclusion criteria | The criterion for inclusion in the study was a suspected CAP as the main diagnosis. This was defined as presence of a new infiltrate on chest X-ray accompanied by one or several acquired respiratory symptoms and signs: 1. Cough 2. Sputum production 3. Dyspnoea 4. Fever over 38.0°C 5. Auscultatory findings of abnormal breath sounds and rales 6. Leukocytosis more than 10 x 10^9 cells/L or leukopenia less than 4 x 10^9 cells/L in the absence of a hospital stay within 14 days before admission |
| Key exclusion criteria | 1. Cystic fibrosis or active tuberculosis 2. Immunocompromised patients, i.e. patients infected with Human Immunodeficiency Virus (HIV) infection and a CD4 count below 200 3. Neutropenic patients with a neutrophil count less than 500 x 10^9/ml 4. Under chemotherapy with neutrophils 500 - 1000 x 10^9/ml with an expected decrease to values less than 500 x 10^9/ml 5. Immunosuppressive therapy after bone marrow or solid organ transplantation 6. Nosocomial pneumonia |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
University Hospital
Basel
4031
Switzerland
4031
Switzerland
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 | 28/06/2006 | Yes | No | ||
| Other publications | 01/07/2006 | Yes | No | ||
| Other publications | 01/11/2007 | Yes | No |
