Procalcitonin in Early Antibiotic Interruption in Patient With Bacterial Pulmonary infeCtion and Acute Heart Failure

Study Overview
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Brief Summary
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Introduction: Acute Heart Failure is frequently decompensated by pulmonary infection, but the diagnosis of pulmonary infection sometimes is difficult in these patients due to similar signals and clinical symptoms in both pathologies. Furthermore, when it is possible the diagnosis of pulmonary infection, physicians may have difficult to determine etiology and delaying antibiotic therapy. Procalcitonin (PCT) have been used like a biomarker to determine the period of use of antibiotics in patients with acute respiratory infections. It is specific for bacterial infections and it have showed as a marker of severity infection and may help to determine interruption period of antibiotic therapy in a safety way for the patient. Aim: Evaluate levels of PCT related to interruption of antibiotics in patients with decompensated acute heart failure (DAHF) with suspected bacterial pulmonary infection. Methods: In this pilot project will be included around 100 patients, randomized in two groups: group A (PCT levels may guide the interruption of antibiotic at day 5) or group B (antibiotic period will be determined by the physician without the knowledge of PCT levels). Will be collected laboratorial and clinical data at days 0,3 and 5. Both groups will be compared to evaluate PCT levels and total period of antibiotic therapy, hospitalization and readmission in 30 days. This study will determine the sensibility/specificity of PCT in patients with DAHF.

Detailed Description
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It is a single-center study, randomized, controlled, prospective cohort and interventional not blind. DAHF diagnosis will consider symptoms, physical examination, x ray and other image methods and BNP ou NTproBNP levels. Pulmonary infection diagnosis will Infectious Disease Society of America / American Thoracic Society Consensus Guidelines on the Management of Community-Acquired Pneumonia in Adults criteria, that include fever, cough, sputum, pleuritic pain, positive pulmonary image and physical examination. PCT and NTproBNP levels will be measured in miniVIDAS® (bioMérieux Clinical Diagnostics, France). Statistics includes descriptive analysis. Parametric data will be evaluated using T test and non parametric data with Mann-Whitney-Wilcoxon test. Multivariative analysis related to diagnosis, mortality and morbidity will be performed by Cox regression model. Sensibility and specificity will be calculated by ROC curve. Statistical significancy will be considered when p<0.05.

Official Title
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Evaluation of Procalcitonin in the Early Antibiotic Therapy Interruption in Patient With Bacterial Pulmonary infeCtion and Decompensated Acute Heart Failure

Conditions
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Respiratory Tract Infections, Pneumonia, Bacterial, Heart Failure

Intervention / Treatment
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* Other: Interruption of antibiotic treatment due to PCT measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DAHF diagnosis and suspected pulmonary infection BNP ≥ 500 pg/mL or NTproBNP ≥ 450 pg/mL for patients until 50 years old. BNP ≥ 500 pg/mL or NTproBNP ≥ 900 pg/mL for patients with 51 - 75 years old. BNP ≥ 500 pg/mL or NTproBNP ≥ 1800 pg/mL for patients older than 75 years. Exclusion Criteria: Antibiotic use (oral or endovenous) in the last 15 days; Acute coronary syndrome; Creatinine > 3,0 mg/dL or hemodialysis; Pregnancy; Second suspectec infection; Suspected pulmonary thromboembolism; cancer; myocarditis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>Interruption of antibiotic treatment due to PCT measurement | Other: Interruption of antibiotic treatment due to PCT measurement<br>* In group A at day 5, if the patient shows no clinical signs of infection and PCT levels < 0,25ng/mL OR PCT > 0,25 ng/mL AND 80% reduction in comparison with day 0 PCT levels, antibiotic will be interrupted. If there is a constant level or decrease less than 80% when compared day 0 or 5, there is no change in antibiotic treatment.<br>|
| No Intervention: group B<br>Antibiotic therapy period will be determined by the physician without the knowledge of PCT levels. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total period of antibiotic therapy |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospitalization |  | 30 days | 
| mortality |  | 30 days | 
| PCT levels during antibiotic therapy |  | 5 days |