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

NCT00350987 | Completed

• 1 other identifier: EKBB87/06
• Study Type: interventional
• Target: 1,002
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Respiratory Tract Infection; Pneumonia; Bronchitis

Keywords

Procalcitonin, guidelines, LRTI, non-inferiority; COLD

Outcome Measures

Primary Outcomes (1)

• the risk of disease specific failure

  within 1 month COPD

Secondary Outcomes (2)

• 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

Study Arms (2)

PCT

EXPERIMENTAL

PCT guidance

Behavioral: a strategy based on PCT guided AB therapy

Guidelines

ACTIVE COMPARATOR

enforced guidelines

Behavioral: a strategy based on PCT guided AB therapy

Interventions

a strategy based on PCT guided AB therapy BEHAVIORAL

In this study a strategy based on PCT guided AB therapy with enforced guideline implementation will be compared.

Guidelines; PCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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".
• Ability to understand verbal and written instructions and informed consent.

You may not qualify if:

• 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.
• Patients with active intravenous drug use.
• Accompanying chronic (e.g. osteomyelitis), abscess (e.g. brain, pleural empyema) infection or endocarditis.
• 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).

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital in Basel

Basel, Canton of Basel-City, 4000, Switzerland

Location

Related Publications (7)

• Christ-Crain M, Morgenthaler NG, Stolz D, Muller C, Bingisser R, Harbarth S, Tamm M, Struck J, Bergmann A, Muller B. Pro-adrenomedullin to predict severity and outcome in community-acquired pneumonia [ISRCTN04176397]. Crit Care. 2006;10(3):R96. doi: 10.1186/cc4955. Epub 2006 Jun 28.

  PMID: 16805922 RESULT

• Christ-Crain M, Stolz D, Bingisser R, Muller C, Miedinger D, Huber PR, Zimmerli W, Harbarth S, Tamm M, Muller B. Procalcitonin guidance of antibiotic therapy in community-acquired pneumonia: a randomized trial. Am J Respir Crit Care Med. 2006 Jul 1;174(1):84-93. doi: 10.1164/rccm.200512-1922OC. Epub 2006 Apr 7.

  PMID: 16603606 RESULT

• Briel M, Christ-Crain M, Young J, Schuetz P, Huber P, Periat P, Bucher HC, Muller B. Procalcitonin-guided antibiotic use versus a standard approach for acute respiratory tract infections in primary care: study protocol for a randomised controlled trial and baseline characteristics of participating general practitioners [ISRCTN73182671]. BMC Fam Pract. 2005 Aug 18;6:34. doi: 10.1186/1471-2296-6-34.

  PMID: 16107222 RESULT

• Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Muller B. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lancet. 2004 Feb 21;363(9409):600-7. doi: 10.1016/S0140-6736(04)15591-8.

  PMID: 14987884 RESULT

• Schuetz P, Wolbers M, Christ-Crain M, Thomann R, Falconnier C, Widmer I, Neidert S, Fricker T, Blum C, Schild U, Morgenthaler NG, Schoenenberger R, Henzen C, Bregenzer T, Hoess C, Krause M, Bucher HC, Zimmerli W, Mueller B; ProHOSP Study Group. Prohormones for prediction of adverse medical outcome in community-acquired pneumonia and lower respiratory tract infections. Crit Care. 2010;14(3):R106. doi: 10.1186/cc9055. Epub 2010 Jun 8.

  PMID: 20529344 DERIVED

• Muller F, Christ-Crain M, Bregenzer T, Krause M, Zimmerli W, Mueller B, Schuetz P; ProHOSP Study Group. Procalcitonin levels predict bacteremia in patients with community-acquired pneumonia: a prospective cohort trial. Chest. 2010 Jul;138(1):121-9. doi: 10.1378/chest.09-2920. Epub 2010 Mar 18.

  PMID: 20299634 DERIVED

• Baehni C, Meier S, Spreiter P, Schild U, Regez K, Bossart R, Thomann R, Falconnier C, Christ-Crain M, De Geest S, Muller B, Schuetz P; ProHOSP Study Group. Which patients with lower respiratory tract infections need inpatient treatment? Perceptions of physicians, nurses, patients and relatives. BMC Pulm Med. 2010 Mar 11;10:12. doi: 10.1186/1471-2466-10-12.

  PMID: 20222964 DERIVED

MeSH Terms

Conditions

Pneumonia; Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Beat Mueller, Prof.

  University Hospital in Basel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2006
• First Posted: July 12, 2006
• Study Start: October 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: September 23, 2008

Record last verified: 2008-09

Locations

CH (1)