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

Primary Purpose

Community Acquired Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Discontinuation of treatment according to CRP levels
Discontinuation of treatment according to PCT levels
Treatment according to current guidelines
Sponsored by
Medical Center Alkmaar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community Acquired Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Centre Alkmaar
  • Slotervaart Hospital
  • ISALA clinics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Common clinical practice

CRP-guided treatment

PCT guided treatment

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Length of antibiotic treatment

Secondary Outcome Measures

Length of stay
Clinical response
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
All cause
Time to clinical stability
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

Full Information

First Posted
September 30, 2013
Last Updated
March 24, 2022
Sponsor
Medical Center Alkmaar
Collaborators
Foreest Medical School, Pulmoscience
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1. Study Identification

Unique Protocol Identification Number
NCT01964495
Brief Title
Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study)
Acronym
REDUCE
Official Title
Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 5, 2013 (Actual)
Primary Completion Date
January 20, 2017 (Actual)
Study Completion Date
January 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Center Alkmaar
Collaborators
Foreest Medical School, Pulmoscience

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Acquired Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
468 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Common clinical practice
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CRP-guided treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
PCT guided treatment
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Discontinuation of treatment according to CRP levels
Other Intervention Name(s)
Broad spectrum antibiotics, Small spectrum antibiotics
Intervention Description
The cutoff point is a CRP below 100 mg/L and a reduction to 50% of the initial value.
Intervention Type
Drug
Intervention Name(s)
Discontinuation of treatment according to PCT levels
Other Intervention Name(s)
Broad spectrum antibiotics, Small spectrum antibiotics
Intervention Description
The cutoff point is a PCT below 0.25 mcg/L or a reduction to 10% of the initial value.
Intervention Type
Drug
Intervention Name(s)
Treatment according to current guidelines
Other Intervention Name(s)
Broad spectrum antibiotics, Small spectrum antibiotics
Intervention Description
Often a 7 days course of antibiotics, treatment may be extended if the attending physician deems it necessary.
Primary Outcome Measure Information:
Title
Length of antibiotic treatment
Time Frame
End of the study
Secondary Outcome Measure Information:
Title
Length of stay
Time Frame
End of the study
Title
Clinical response
Description
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.
Time Frame
End of the study
Title
30-day mortality
Description
All cause
Time Frame
End of the study, periodically by the DSMB
Title
Time to clinical stability
Description
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.
Time Frame
End of the study
Title
Relapse rate
Time Frame
End of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients with a diagnosis of CAP and all criteria listed below: Age 18 or above, no upper age limit will be employed. Patients must require hospitalisation. Clinical presentation of an acute illness with one or more of the following symptoms: Temperature ≥ 38.0 ⁰C (100.4°F) Dyspnoea Cough (with or without expectoration of sputum) Chest pain Malaise or fatigue Myalgia Gastro-intestinal symptoms Rales, rhonchi or wheezing Egophony or bronchial breath sounds New consolidation(s) on the chest radiograph. Written informed consent obtained. (Pre-event) Life expectancy > 30 days Exclusion Criteria: Subjects presenting with any of the following will not be included in the study: (Severe) immunosuppression (e.g. HIV infection, chemotherapy, use of immunosuppressants). Active neoplastic disease. Obstruction pneumonia (e.g. from lung cancer). Aspiration pneumonia. Pneumonia that developed within 8 days after hospital discharge. Unable and/or unlikely to comprehend and/or follow the protocol. Pregnant and/or lactating women. Other infection that requires treatment with antibiotics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruud Duijkers, MSc, MD
Organizational Affiliation
Medisch Centrum Alkmaar
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wim G Boersma, MD, PhD, MSc
Organizational Affiliation
Medisch Centrum Alkmaar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dominic Snijders, MSc, PhD, MD
Organizational Affiliation
Slotervaart ziekenhuis
Official's Role
Study Chair
Facility Information:
Facility Name
Medical Centre Alkmaar
City
Alkmaar
State/Province
Noord Holland
ZIP/Postal Code
1815JD
Country
Netherlands
Facility Name
Slotervaart Hospital
City
Amsterdam
State/Province
Noord Holland
ZIP/Postal Code
1006BK
Country
Netherlands
Facility Name
ISALA clinics
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8025 AB
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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