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

Gertrud Baunbaek Egelund

Status: Unknown

Conditions: Community Acquired Pneumonia

Treatments: Behavioral: PCT-algorithm; Behavioral: CRP-algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT03146182

2015-002501-11 (EudraCT Number)

BIO-CAP_NZH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Control

No Intervention group

Description:

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

CRP

Experimental group

Description:

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

Treatment:

Behavioral: CRP-algorithm

PCT

Experimental group

Description:

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

Treatment:

Behavioral: PCT-algorithm