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

NCT02787603 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2017-06-06

No results posted yet for this study

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.

Conditions

  • Respiratory Tract Infections
  • Pneumonia, Bacterial
  • Heart Failure

Interventions

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.

Sponsors & Collaborators

  • BioMérieux

    collaborator INDUSTRY

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Mucio Tavares, PhD MD · Unidade Clínica de Emergência

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-01-31
Completion
2017-04-30

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02787603 on ClinicalTrials.gov