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

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ClinicalTrials.gov Identifier: NCT02787603
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : June 6, 2017
Sponsor:
Collaborator:
BioMérieux
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Pneumonia, Bacterial Heart Failure Other: Interruption of antibiotic treatment due to PCT measurement Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Procalcitonin in the Early Antibiotic Therapy Interruption in Patient With Bacterial Pulmonary infeCtion and Decompensated Acute Heart Failure
Actual Study Start Date : January 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: group A
Interruption of antibiotic treatment due to PCT measurement
Other: Interruption of antibiotic treatment due to PCT measurement
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.

No Intervention: group B
Antibiotic therapy period will be determined by the physician without the knowledge of PCT levels.



Primary Outcome Measures :
  1. Total period of antibiotic therapy [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. hospitalization [ Time Frame: 30 days ]
  2. mortality [ Time Frame: 30 days ]
  3. PCT levels during antibiotic therapy [ Time Frame: 5 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787603


Locations
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Brazil
Unidade Clínica de Emergência - Instituto do Coração InCor HCFMUSP
São Paulo, SP, Brazil, 05403000
Sponsors and Collaborators
University of Sao Paulo General Hospital
BioMérieux
Investigators
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Principal Investigator: Mucio Tavares, PhD MD Unidade Clínica de Emergência

Publications of Results:

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02787603     History of Changes
Other Study ID Numbers: PSInCor-Procalcitonin Clinical
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Infection
Communicable Diseases
Heart Failure
Pneumonia
Respiratory Tract Infections
Pneumonia, Bacterial
Heart Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Bacterial Infections