Procalcitonin Guided Antibiotic Therapy and Hospitalisation in Patients With Lower Respiratory Tract Infections: The "ProHOSP" Study

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00350987
First received: July 11, 2006
Last updated: September 22, 2008
Last verified: September 2008
  Purpose

The aim of this study is to test if procalcitonin (PCT) guided antibiotic stewardship in patients with lower respiratory tract infection (LRTI) will be non-inferior, with at worst a 7.5% higher combined failure rate, as compared to standard care practice (current guidelines for LRTI) with reduced total antibiotic (AB) use and hospitalization rate and duration, respectively.


Condition Intervention
Lower Respiratory Tract Infection
Pneumonia
Bronchitis
Behavioral: a strategy based on PCT guided AB therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Procalcitonin Guided Antibiotic Therapy and Hospitalisation in Patients With Lower Respiratory Tract Infections: The "ProHOSP" Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • the risk of disease specific failure [ Time Frame: within 1 month COPD ]

Secondary Outcome Measures:
  • time to AB treatment/prescription rate, duration, rate and doses, first change, side-effects, hospitalization and discharge
  • clinical stability, disease activity score, restriction days, function/health state, prediction rules and diagnostic and prognostic accuracy

Enrollment: 1002
Study Start Date: October 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCT
PCT guidance
Behavioral: a strategy based on PCT guided AB therapy
In this study a strategy based on PCT guided AB therapy with enforced guideline implementation will be compared.
Active Comparator: Guidelines
enforced guidelines
Behavioral: a strategy based on PCT guided AB therapy
In this study a strategy based on PCT guided AB therapy with enforced guideline implementation will be compared.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 18 years of age or older, admitted from the community or a nursing home with acute (i.e., at least 1 day but less than 28 days) 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 > 38.0° C, leukocyte count > 10 or < 4 x 10^9 cells L-1).
    • 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.
    • COPD is defined by post-bronchodilator spirometric criteria according to the GOLD-guidelines as a FEV1/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 an 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 not understanding German (or other local language) and no translation (e.g. family members) available.
  2. Patients with active intravenous drug use.
  3. Severe immunosuppression (e.g. patients infected with human immunodeficiency virus 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 < 500 x 10^9/L and patients under chemotherapy with neutrophils 500-1000 x 10^9/L with an expected decrease to values < 500 x 10^9/L); patients with cystic fibrosis, infection with M. tuberculosis, L. pneumophila, Listeria spp. 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 has to be expected in the current hospitalization (e.g. due to malignancy, cardiac, renal or hepatic failure, comfort therapy).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350987

Locations
Switzerland
University Hospital in Basel
Basel, BS, Switzerland, 4000
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Mjriam Christ-Crain, Dr.med. University Hospital in Basel
Principal Investigator: Philipp Schuetz, Dr.med. University Hospital in Basel
Principal Investigator: Werner Zimmerli, Prof. University Hospital in Liestal, Switzerland
Study Director: Beat Mueller, Prof. University Hospital in Basel
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00350987     History of Changes
Other Study ID Numbers: EKBB87/06
Study First Received: July 11, 2006
Last Updated: September 22, 2008
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
Procalcitonin, guidelines, LRTI, non-inferiority
COLD

Additional relevant MeSH terms:
Bronchitis
Pneumonia
Respiratory Tract Infections
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 24, 2014