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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

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.

Condition or disease Intervention/treatment Phase
Community Acquired Pneumonia Drug: Discontinuation of treatment according to CRP levels Drug: Discontinuation of treatment according to PCT levels Drug: Treatment according to current guidelines Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study)
Actual Study Start Date : December 5, 2013
Actual Primary Completion Date : January 20, 2017
Actual Study Completion Date : January 20, 2017

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Arm Intervention/treatment
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.
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

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.
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

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.
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




Primary Outcome Measures :
  1. Length of antibiotic treatment [ Time Frame: End of the study ]

Secondary Outcome Measures :
  1. Length of stay [ Time Frame: End of the study ]
  2. 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.


  3. 30-day mortality [ Time Frame: End of the study, periodically by the DSMB ]
    All cause

  4. 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.

  5. Relapse rate [ Time Frame: End of the study ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964495


Locations
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Netherlands
Medical Centre Alkmaar
Alkmaar, Noord Holland, Netherlands, 1815JD
Slotervaart Hospital
Amsterdam, Noord Holland, Netherlands, 1006BK
ISALA clinics
Zwolle, Overijssel, Netherlands, 8025 AB
Sponsors and Collaborators
Medical Center Alkmaar
Pulmo Science
Chiesi Farmaceutici S.p.A.
Investigators
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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

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Responsible Party: W.G.Boersma, MSc, MD, PhD, Medical Center Alkmaar
ClinicalTrials.gov Identifier: NCT01964495     History of Changes
Other Study ID Numbers: 1-Duijkers
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents