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Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study) (REDUCE)

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ClinicalTrials.gov Identifier: NCT01964495
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : January 24, 2017
Sponsor:
Collaborators:
Pulmo Science
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
W.G.Boersma, Medical Center Alkmaar

Tracking Information
First Submitted Date  ICMJE September 30, 2013
First Posted Date  ICMJE October 17, 2013
Last Update Posted Date January 24, 2017
Actual Study Start Date  ICMJE December 5, 2013
Actual Primary Completion Date January 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2013)
Length of antibiotic treatment [ Time Frame: End of the study ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01964495 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2013)
  • Length of stay [ Time Frame: End of the study ]
  • Clinical response [ Time Frame: End of the study ]
    Cure — resolution or improvement of symptoms and clinical signs related to pneumonia without the need for additional or alternative antibiotic therapy Failure — persistence or progression of all signs and symptoms of the acute process after randomisation or the development of a new pulmonary or extrapulmonary respiratory tract infection, or the progression of abnormalities on chest radiograph after randomisation, or death due to pneumonia, or the inability to complete the study owing to adverse events Indeterminate — patient receives less than 80% of the study drug for reasons other than clinical failure, a concomitant infection outside the respiratory tract requiring antibiotic treatment, lost to follow-up, or death unrelated to the primary diagnosis.
  • 30-day mortality [ Time Frame: End of the study, periodically by the DSMB ]
    All cause
  • Time to clinical stability [ Time Frame: End of the study ]
    Patients are considered clinically stable if they fulfill all of these criteria: Temperature equal to or below 37.8 degrees celsius, heart rate equal to or below 100 beats per minute, respiratory rate equal to or below 24 breaths per minute, systolic blood pressure equal to or above 90 mmHg, arterial oxygen saturation equal to or above 90 percent or pO2 equal to or above 60 mmHg on room air, ability to maintain oral intake, normal mental status.
  • Relapse rate [ Time Frame: End of the study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study)
Official Title  ICMJE Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study)
Brief Summary The purpose of this study is to evaluate two different treatment strategies in patients admitted to hospital with Community Acquired Pneumonia. The investigators hypothesize treatment according to both procalcitonin (PCT) and C-reactive protein (CRP) will be effective in reducing the length of antibiotic treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Community Acquired Pneumonia
Intervention  ICMJE
  • Drug: Discontinuation of treatment according to CRP levels
    The cutoff point is a CRP below 100 mg/L and a reduction to 50% of the initial value.
    Other Names:
    • Broad spectrum antibiotics
    • Small spectrum antibiotics
  • Drug: Discontinuation of treatment according to PCT levels
    The cutoff point is a PCT below 0.25 mcg/L or a reduction to 10% of the initial value.
    Other Names:
    • Broad spectrum antibiotics
    • Small spectrum antibiotics
  • Drug: Treatment according to current guidelines
    Often a 7 days course of antibiotics, treatment may be extended if the attending physician deems it necessary.
    Other Names:
    • Broad spectrum antibiotics
    • Small spectrum antibiotics
Study Arms  ICMJE
  • Active Comparator: Common clinical practice
    Treatment according to current guidelines. Often a 7 day course of antibiotics. Initial treatment should be broad spectrum antibiotics and can be narrowed down if a specific pathogen is identified.
    Intervention: Drug: Treatment according to current guidelines
  • Experimental: CRP-guided treatment
    Treatment according to CRP levels. Patients will be started on broad spectrum antibiotics for at least 3 days, treatment can be switched to small-spectrum antibiotics if a specific pathogen is identified. From day 4 to 7 daily blood tests will be performed in order to evaluate whether or not treatment can be discontinued. If treatment is discontinued, no more blood tests will be performed.
    Intervention: Drug: Discontinuation of treatment according to CRP levels
  • Experimental: PCT guided treatment
    Treatment according to PCT levels. Patients will be started on broad spectrum antibiotics for at least 3 days, treatment can be switched to small-spectrum antibiotics if a specific pathogen is identified. From day 4 to 7 daily blood tests will be performed in order to evaluate whether or not treatment can be discontinued. If treatment is discontinued, no more blood tests will be performed.
    Intervention: Drug: Discontinuation of treatment according to PCT levels
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2013)
468
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 20, 2017
Actual Primary Completion Date January 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Male and female patients with a diagnosis of CAP and all criteria listed below:

  1. Age 18 or above, no upper age limit will be employed.
  2. Patients must require hospitalisation.
  3. Clinical presentation of an acute illness with one or more of the following symptoms:

    1. Temperature ≥ 38.0 ⁰C (100.4°F)
    2. Dyspnoea
    3. Cough (with or without expectoration of sputum)
    4. Chest pain
    5. Malaise or fatigue
    6. Myalgia
    7. Gastro-intestinal symptoms
    8. Rales, rhonchi or wheezing
    9. Egophony or bronchial breath sounds
  4. New consolidation(s) on the chest radiograph.
  5. Written informed consent obtained.
  6. (Pre-event) Life expectancy > 30 days

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

  1. (Severe) immunosuppression (e.g. HIV infection, chemotherapy, use of immunosuppressants).
  2. Active neoplastic disease.
  3. Obstruction pneumonia (e.g. from lung cancer).
  4. Aspiration pneumonia.
  5. Pneumonia that developed within 8 days after hospital discharge.
  6. Unable and/or unlikely to comprehend and/or follow the protocol.
  7. Pregnant and/or lactating women.
  8. Other infection that requires treatment with antibiotics
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01964495
Other Study ID Numbers  ICMJE 1-Duijkers
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party W.G.Boersma, Medical Center Alkmaar
Study Sponsor  ICMJE Medical Center Alkmaar
Collaborators  ICMJE
  • Pulmo Science
  • Chiesi Farmaceutici S.p.A.
Investigators  ICMJE
Study Director: Ruud Duijkers, MSc, MD Medisch Centrum Alkmaar
Principal Investigator: Wim G Boersma, MD, PhD, MSc Medisch Centrum Alkmaar
Study Chair: Dominic Snijders, MSc, PhD, MD Slotervaart ziekenhuis
PRS Account Medical Center Alkmaar
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP