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

May 9, 2017 updated by: Gertrud Baunbaek Egelund
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Patients are treated according to current local guidelines on antibiotic treatment for CAP.
Experimental: CRP
Patients are treated according to the CRP-algorithm. CRP is measured daily. Antibiotic treatment is stopped when CRP reach threshold value.
Behavioral: CRP-algorithm
a strategy based on CRP guided antibiotic stewardship
Experimental: PCT
Patients are treated according to the PCT-algorithm. PCT is measured daily. Antibiotic treatment is stopped when PCT reach threshold value.
Behavioral: PCT-algorithm
a strategy based on PCT guided antibiotic stewardship

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of antibiotic treatment
Time Frame: 30 days from inclusion
Number of days in antibiotic treatment for pneumonia
30 days from inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 day mortality
Time Frame: 30 days from inclusion
Number of patients who die within 30 days.
30 days from inclusion
Relapse
Time Frame: 30 days from inclusion
Number of patients who are readmitted due to pneumonia or resumed treatment for pneumonia.
30 days from inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gertrud Baunbaek Egelund

Investigators

  • Principal Investigator: Gertrud B Egelund, M.D., Department of pulmonary and infectious diseases, Nordsjaellands Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2017

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

May 5, 2017

First Submitted That Met QC Criteria

May 5, 2017

First Posted (Actual)

May 9, 2017

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 9, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO-CAP_NZH
  • 2015-002501-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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