NCT02787603

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 6, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

May 25, 2016

Last Update Submit

June 5, 2017

Conditions

Respiratory Tract InfectionsPneumonia, BacterialHeart Failure

Outcome Measures

Primary Outcomes (1)

  • Total period of antibiotic therapy

    30 days

Secondary Outcomes (3)

  • hospitalization

    30 days

  • mortality

    30 days

  • PCT levels during antibiotic therapy

    5 days

Study Arms (2)

group A

EXPERIMENTAL

Interruption of antibiotic treatment due to PCT measurement

Other: 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.

Interventions

Interruption of antibiotic treatment due to PCT measurementOTHER

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.

group A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidade Clínica de Emergência - Instituto do Coração InCor HCFMUSP

São Paulo, São Paulo, 05403000, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 22302662RESULT

  • 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.

    PMID: 21936959RESULT

  • 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.

    PMID: 21030489RESULT

  • 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.

    PMID: 20097417RESULT

  • 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.

    PMID: 25005339RESULT

MeSH Terms

Conditions

Respiratory Tract InfectionsPneumonia, BacterialHeart Failure

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesBacterial InfectionsBacterial Infections and MycosesPneumoniaLung DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Mucio Tavares, PhD MD

    Unidade Clínica de Emergência

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2016

First Posted

June 1, 2016

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

April 1, 2017

Last Updated

June 6, 2017

Record last verified: 2017-01

Locations

BR(1)