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| Name | Class |
|---|---|
| BioMérieux | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental | Interruption of antibiotic treatment due to PCT measurement |
|
| group B | No Intervention | Antibiotic therapy period will be determined by the physician without the knowledge of PCT levels. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interruption of antibiotic treatment due to PCT measurement | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total period of antibiotic therapy | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| hospitalization | 30 days | |
| mortality | 30 days | |
| PCT levels during antibiotic therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mucio Tavares, PhD MD | Unidade ClÃnica de Emergência | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade ClÃnica de Emergência - Instituto do Coração InCor HCFMUSP | São Paulo | São Paulo | 05403000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22302662 | Result | 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. | |
| 21936959 |
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|
| 5 days |
| Result |
| 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. |
| 21030489 | Result | 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. |
| 20097417 | Result | 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. |
| 25005339 | Result | 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. |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D018410 | Pneumonia, Bacterial |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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