Procalcitonin in Early Antibiotic Interruption in Patient With Bacterial Pulmonary infeCtion and Acute Heart Failure (EPICAD)
Primary Purpose
Respiratory Tract Infections, Pneumonia, Bacterial, Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Interruption of antibiotic treatment due to PCT measurement
Sponsored by
![University of Sao Paulo General Hospital](https://trials-media.s3.amazonaws.com/orgs/university-of-sao-paulo-general-hospital.jpeg)
About this trial
This is an interventional treatment trial for Respiratory Tract Infections
Eligibility 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.
Sites / Locations
- Unidade Clínica de Emergência - Instituto do Coração InCor HCFMUSP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
group A
group B
Arm Description
Interruption of antibiotic treatment due to PCT measurement
Antibiotic therapy period will be determined by the physician without the knowledge of PCT levels.
Outcomes
Primary Outcome Measures
Total period of antibiotic therapy
Secondary Outcome Measures
hospitalization
mortality
PCT levels during antibiotic therapy
Full Information
NCT ID
NCT02787603
First Posted
May 25, 2016
Last Updated
June 5, 2017
Sponsor
University of Sao Paulo General Hospital
Collaborators
BioMérieux
1. Study Identification
Unique Protocol Identification Number
NCT02787603
Brief Title
Procalcitonin in Early Antibiotic Interruption in Patient With Bacterial Pulmonary infeCtion and Acute Heart Failure
Acronym
EPICAD
Official Title
Evaluation of Procalcitonin in the Early Antibiotic Therapy Interruption in Patient With Bacterial Pulmonary infeCtion and Decompensated Acute Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
BioMérieux
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections, Pneumonia, Bacterial, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
Interruption of antibiotic treatment due to PCT measurement
Arm Title
group B
Arm Type
No Intervention
Arm Description
Antibiotic therapy period will be determined by the physician without the knowledge of PCT levels.
Intervention Type
Other
Intervention Name(s)
Interruption of antibiotic treatment due to PCT measurement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total period of antibiotic therapy
Time Frame
30 days
Secondary Outcome Measure Information:
Title
hospitalization
Time Frame
30 days
Title
mortality
Time Frame
30 days
Title
PCT levels during antibiotic therapy
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mucio Tavares, PhD MD
Organizational Affiliation
Unidade Clínica de Emergência
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unidade Clínica de Emergência - Instituto do Coração InCor HCFMUSP
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22302662
Citation
Maisel A, Neath SX, Landsberg J, Mueller C, Nowak RM, Peacock WF, Ponikowski P, Mockel M, Hogan C, Wu AH, Richards M, Clopton P, Filippatos GS, Di Somma S, Anand I, Ng LL, Daniels LB, Christenson RH, Potocki M, McCord J, Terracciano G, Hartmann O, Bergmann A, Morgenthaler NG, Anker SD. Use of procalcitonin for the diagnosis of pneumonia in patients presenting with a chief complaint of dyspnoea: results from the BACH (Biomarkers in Acute Heart Failure) trial. Eur J Heart Fail. 2012 Mar;14(3):278-86. doi: 10.1093/eurjhf/hfr177. Epub 2012 Feb 2.
Results Reference
result
PubMed Identifier
21936959
Citation
Schuetz P, Albrich W, Mueller B. Procalcitonin for diagnosis of infection and guide to antibiotic decisions: past, present and future. BMC Med. 2011 Sep 22;9:107. doi: 10.1186/1741-7015-9-107.
Results Reference
result
PubMed Identifier
21030489
Citation
Bafadhel M, Clark TW, Reid C, Medina MJ, Batham S, Barer MR, Nicholson KG, Brightling CE. Procalcitonin and C-reactive protein in hospitalized adult patients with community-acquired pneumonia or exacerbation of asthma or COPD. Chest. 2011 Jun;139(6):1410-1418. doi: 10.1378/chest.10-1747. Epub 2010 Oct 28.
Results Reference
result
PubMed Identifier
20097417
Citation
Bouadma L, Luyt CE, Tubach F, Cracco C, Alvarez A, Schwebel C, Schortgen F, Lasocki S, Veber B, Dehoux M, Bernard M, Pasquet B, Regnier B, Brun-Buisson C, Chastre J, Wolff M; PRORATA trial group. Use of procalcitonin to reduce patients' exposure to antibiotics in intensive care units (PRORATA trial): a multicentre randomised controlled trial. Lancet. 2010 Feb 6;375(9713):463-74. doi: 10.1016/S0140-6736(09)61879-1. Epub 2010 Jan 25.
Results Reference
result
PubMed Identifier
25005339
Citation
Schuetz P, Kutz A, Grolimund E, Haubitz S, Demann D, Vogeli A, Hitz F, Christ-Crain M, Thomann R, Falconnier C, Hoess C, Henzen C, Marlowe RJ, Zimmerli W, Mueller B; ProHOSP Study Group. Excluding infection through procalcitonin testing improves outcomes of congestive heart failure patients presenting with acute respiratory symptoms: results from the randomized ProHOSP trial. Int J Cardiol. 2014 Aug 20;175(3):464-72. doi: 10.1016/j.ijcard.2014.06.022. Epub 2014 Jun 27.
Results Reference
result
Learn more about this trial
Procalcitonin in Early Antibiotic Interruption in Patient With Bacterial Pulmonary infeCtion and Acute Heart Failure
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