Biomarker Guided Antibiotic Treatment in Community-Acquired Pneumonia

Community Acquired Pneumonia Clinical Trial

— BIO-CAP  

Official title:

Biomarker Guided Antibiotic Treatment in Community-Acquired Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03146182
• Other study ID #: BIO-CAP_NZH
• Secondary ID: 2015-002501-11
• Status: Recruiting
• Phase: N/A
• First received: May 5, 2017
• Last updated: May 9, 2017
• Start date: March 15, 2017
• Est. completion date: February 2019

Study information

• Verified date: May 2017
• Source: Nordsjaellands Hospital
• Contact: Gertrud B Egelund, M.D.
• Phone: 004548293051
• Email: gertrud.baunbaek.egelund[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Pneumonia

Intervention

Behavioral:
• CRP-algorithm
a strategy based on CRP guided antibiotic stewardship
• PCT-algorithm
a strategy based on PCT guided antibiotic stewardship

Locations

Country	Name	City	State
Denmark	Nordsjællands Hospital.	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Gertrud Baunbaek Egelund

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of antibiotic treatment	Number of days in antibiotic treatment for pneumonia	30 days from inclusion
Secondary	30 day mortality	Number of patients who die within 30 days.	30 days from inclusion
Secondary	Relapse	Number of patients who are readmitted due to pneumonia or resumed treatment for pneumonia.	30 days from inclusion