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11 February 2012
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| [ Print-friendly version ] |
| Procalcitonin guided reduction of the duration of antibiotic therapy in Community Acquired Pneumonia |
| ISRCTN | ISRCTN04176397 |
| ClinicalTrials.gov identifier | |
| Public title | Procalcitonin guided reduction of the duration of antibiotic therapy in Community Acquired Pneumonia |
| Scientific title | |
| Acronym | ProCAP-Study/ProResp II-Study |
| Serial number at source | EKBB 232/03 |
| Study hypothesis |
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. |
| Lay summary | |
| Ethics approval | 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. |
| Study design | Randomised controlled trial |
| Countries of recruitment | Switzerland |
| Disease/condition/study domain | Community Acquired Pneumonia (CAP) |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/01/2004 |
| Anticipated end date | 31/12/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 250 |
| Interventions |
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). |
| Primary outcome measure(s) | Total antibiotic use, recorded on days 4, 6, and 8 and at follow-up after 6 weeks. |
| Secondary outcome measure(s) | Measures of laboratory and clinical outcomes, recorded on days 4, 6, and 8 and at follow-up after 6 weeks. |
| Sources of funding |
1. University Hospital Basel (Switzerland):
1.1. Clinic of Pulmonary Medicine 1.2. Clinic of Endocrinology 1.3. Emergency Unit 1.4. Department of Internal Medicine 1.5. Department of Central Laboratories (infrastructure) 2. BRAHMS AG (Germany) - assay material |
| Trial website | |
| Publications |
Results in:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=16805922 2. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17702966 3. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=16603606 |
| Contact name | Prof Beat Muller |
| Address |
University Hospital
Petersgraben 4 |
| City/town | Basel |
| Zip/Postcode | 4031 |
| Country | Switzerland |
| Tel | +41 (0)61 265 2525 |
| Fax | +41 (0)61 265 5100 |
| Happy.Mueller@unibas.ch | |
| Sponsor | University Hospital Basel (Switzerland) |
| Address | Petersgraben 4 |
| City/town | Basel |
| Zip/Postcode | 4031 |
| Country | Switzerland |
| Tel | +41 (0)61 265 2525 |
| Fax | +41 (0)61 265 5100 |
| Happy.Mueller@unibas.ch | |
| Sponsor website: | http://www.universitaetsspital-basel.ch/ |
| Date applied | 18/01/2005 |
| Last edited | 19/11/2007 |
| Date ISRCTN assigned | 15/02/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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