Procalcitonin-guided antibiotic therapy and hospitalisation in patients with lower respiratory tract infections: the ProHOSP study

Not Applicable

Completed

• Conditions: ower respiratory tract infection (LRTI); Respiratory; Lower respiratory tract infection

• Registration Number: ISRCTN95122877
• Lead Sponsor: niversity Hospital of Basel (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-31
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1002

Inclusion Criteria

1. Patients 18 years of age or older, admitted from the community or a nursing home with acute i.e. at least for 1 day but less than 28 days) lower respiratory tract infection (LRTI) as the main diagnosis consisting of having at least two of the following: new or increased respiratory signs or symptoms (i.e. cough, sputum production, dyspnea, auscultatory findings of abnormal breath sounds and rales, pleuritic chest pain) with or without inflammatory signs (core body temperature greater than 38.0°C, leukocyte count greater than 10 or less than 4 x 10^9 cells/l).
Community-acquired pneumonia (CAP) is defined by the presence of LRTI along with a new or increased infiltrate on chest radiograph. Severity scores of CAP (pneumonia severity index [PSI] and CURB-65) will be calculated.
Chronic obstructive pulmonary disease (COPD) is defined by post-bronchodilator spirometric criteria according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines as a forced expiratory volume in one second (FEV1) or forced vital capacity (FVC) ratio below 70% and the severity categorized into mild (FEV1 =80% of predicted), moderate (50%= FEV1 <80%), severe (30%= FEV1 <50%) and very severe (FEV1 <30%), respectively. Severity of acute exacerbations of COPD will be graded as proposed.
Acute bronchitis is defined as LRTI in the absence of an underlying lung disease or focal chest signs and infiltrates on chest x-ray, respectively. Patients who are on admission judged as having a LRTI but have another final diagnosis, will be classified as 'others'.
2. Ability to understand verbal and written instructions and informed consent

Exclusion Criteria

1. Patients unable to give written informed consent e.g. with severe dementia or patients who cannot understand German (or other local language) and where there are no translators (e.g. family members) available
2. Patients with active intravenous drug use
3. Severe immunosuppression (e.g. patients infected with human immunodeficiency virus [HIV] infection and a CD4 count below 350 x 10^9/l, patients on immunosuppressive therapy after solid organ transplantation and neutropenic patients with present neutrophil count less than 500 x 10^9/l, patients under chemotherapy with neutrophils of 500 - 1000 x 10^9/l with an expected decrease to values of less than 500 x 10^9/l), patients with cystic fibrosis, infected with Mycobacterium tuberculosis, Legionella pneumophila, Listeria spp. and hospital stay within 14 days of inclusion
4. Accompanying chronic (e.g. osteomyelitis), abscess, (e.g. brain, pleural empyema) infection or endocarditis
5. Terminal and very severe medical co-morbidity where death is imminent or is expected in current hospitalisation (e.g. due to malignancy, cardiac, renal or hepatic failure, comfort therapy)

Study & Design

• Study Type: Interventional
• Study Design: Not specified