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Biomarker Guided Antibiotic Treatment in Community-Acquired Pneumonia (BIO-CAP)

Primary Purpose

Community Acquired Pneumonia

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CRP-algorithm
PCT-algorithm
Sponsored by
Gertrud Baunbaek Egelund
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community Acquired Pneumonia focused on measuring C-reactive protein, Procalcitonin, Community-acquired pneumonia, Antibiotic stewardship

Eligibility Criteria

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

Inclusion Criteria:

  • Patients 18 years of age or older admitted to hospital with community acquired pneumonia defined as a new infiltrate on x-ray and at least one of the following; cough, expectoration, dyspnea, fever and pathological lung-auscultation.
  • Not admitted to hospital within the last 14 days
  • The patients has been prescribed antibiotic treatment for pneumonia
  • The patient can comprehend the written and verbal information and has provided written consent.

Exclusion Criteria:

  • Patient are unable to give written consent or patient does not understand the Danish language.
  • Active pulmonary tuberculosis
  • Severe immunosuppression determined by the treating physician (i.e. treatment with highdose corticosteroid for more than 2 weeks, chemotherapy and neutropenia with neutrophils < 0.5x109/l, ongoing treatment with biological drugs, chronic HIV-infection with CD4 cell count < 350 mio./l, immunosuppression after organ transplantation).
  • Pregnancy and breastfeeding
  • Patients admitted to hospital and treated against their will.
  • Terminal ill patients where active treatment is stopped within the first 48 hours of admission.
  • Patients who are, from the date of inclusion, prescribed antibiotic treatment for more than 3 days on a different indication than pneumonia.

Sites / Locations

  • Nordsjællands Hospital.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

CRP

PCT

Arm Description

Patients are treated according to current local guidelines on antibiotic treatment for CAP.

Patients are treated according to the CRP-algorithm. CRP is measured daily. Antibiotic treatment is stopped when CRP reach threshold value.

Patients are treated according to the PCT-algorithm. PCT is measured daily. Antibiotic treatment is stopped when PCT reach threshold value.

Outcomes

Primary Outcome Measures

Duration of antibiotic treatment
Number of days in antibiotic treatment for pneumonia

Secondary Outcome Measures

30 day mortality
Number of patients who die within 30 days.
Relapse
Number of patients who are readmitted due to pneumonia or resumed treatment for pneumonia.

Full Information

First Posted
May 5, 2017
Last Updated
May 9, 2017
Sponsor
Gertrud Baunbaek Egelund
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1. Study Identification

Unique Protocol Identification Number
NCT03146182
Brief Title
Biomarker Guided Antibiotic Treatment in Community-Acquired Pneumonia
Acronym
BIO-CAP
Official Title
Biomarker Guided Antibiotic Treatment in Community-Acquired Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gertrud Baunbaek Egelund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the efficacy of C-reactive protein and procalcitonin based guidelines versus standard of care to reduce duration of antibiotic exposure in patients hospitalized with community acquired pneumonia.
Detailed Description
BIO-CAP is a prospective randomized intervention study which aims to evaluate the efficacy of C-reactive protein (CRP) based guidelines and procalcitonin (PCT) based guidelines to reduce duration of antibiotic exposure in adult patients hospitalized with community-acquired pneumonia (CAP) compared to standard-of-care. Hypothesis: the duration of antibiotic exposure can be reduced when a biomarker algorithm - in addition to standard of care - is used to stop antibiotic treatment. 1) CRP based guidelines can reduce duration of antibiotic exposure equally to procalcitonin based guidelines and 2) Either of these two biomarker algorithms ( CRP or PCT) are superior compared to standard of care. Sample size. Preconditions: significance level (α) 5 % and power (β) 80 %. Test: unpaired T-test. Mean treatment time 11 days (SD 5) in this population. Relevant detection limit defined at 2 days. The bonferroni correction has been used to correct for the fact that 2 primary analysis will be performed, why α = 0.005/2 = 0.025. Estimated 100 patient in each arm, thus n = 300. Site monitoring and auditing. The study is monitored by the unit for Good Clinical Practice, Bispebjerg Hospital, Denmark.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Acquired Pneumonia
Keywords
C-reactive protein, Procalcitonin, Community-acquired pneumonia, Antibiotic stewardship

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients are treated according to current local guidelines on antibiotic treatment for CAP.
Arm Title
CRP
Arm Type
Experimental
Arm Description
Patients are treated according to the CRP-algorithm. CRP is measured daily. Antibiotic treatment is stopped when CRP reach threshold value.
Arm Title
PCT
Arm Type
Experimental
Arm Description
Patients are treated according to the PCT-algorithm. PCT is measured daily. Antibiotic treatment is stopped when PCT reach threshold value.
Intervention Type
Behavioral
Intervention Name(s)
CRP-algorithm
Intervention Description
a strategy based on CRP guided antibiotic stewardship
Intervention Type
Behavioral
Intervention Name(s)
PCT-algorithm
Intervention Description
a strategy based on PCT guided antibiotic stewardship
Primary Outcome Measure Information:
Title
Duration of antibiotic treatment
Description
Number of days in antibiotic treatment for pneumonia
Time Frame
30 days from inclusion
Secondary Outcome Measure Information:
Title
30 day mortality
Description
Number of patients who die within 30 days.
Time Frame
30 days from inclusion
Title
Relapse
Description
Number of patients who are readmitted due to pneumonia or resumed treatment for pneumonia.
Time Frame
30 days from inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 18 years of age or older admitted to hospital with community acquired pneumonia defined as a new infiltrate on x-ray and at least one of the following; cough, expectoration, dyspnea, fever and pathological lung-auscultation. Not admitted to hospital within the last 14 days The patients has been prescribed antibiotic treatment for pneumonia The patient can comprehend the written and verbal information and has provided written consent. Exclusion Criteria: Patient are unable to give written consent or patient does not understand the Danish language. Active pulmonary tuberculosis Severe immunosuppression determined by the treating physician (i.e. treatment with highdose corticosteroid for more than 2 weeks, chemotherapy and neutropenia with neutrophils < 0.5x109/l, ongoing treatment with biological drugs, chronic HIV-infection with CD4 cell count < 350 mio./l, immunosuppression after organ transplantation). Pregnancy and breastfeeding Patients admitted to hospital and treated against their will. Terminal ill patients where active treatment is stopped within the first 48 hours of admission. Patients who are, from the date of inclusion, prescribed antibiotic treatment for more than 3 days on a different indication than pneumonia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gertrud B Egelund, M.D.
Phone
004548293051
Email
gertrud.baunbaek.egelund@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Pernille Ravn, M.D.
Phone
004548296977
Email
pernille.ravn@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gertrud B Egelund, M.D.
Organizational Affiliation
Department of pulmonary and infectious diseases, Nordsjaellands Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nordsjællands Hospital.
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gertrud B Egelund, M.D.
Phone
004548293051
Email
gertrud.baunbaek.egelund@regionh.dk
First Name & Middle Initial & Last Name & Degree
Pernille Ravn, M.D. ph.D.
Phone
004548296977
Email
pernille.ravn@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Biomarker Guided Antibiotic Treatment in Community-Acquired Pneumonia

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