NCT00934011

Brief Summary

In this study the investigators aim to test if C-reactive protein (CRP)or procalcitonin(PCT) - guided strategy allows to reduce the antibiotic use in patients wiht severe sepsis and septic shock. Therefore, the safety of this intervention will be carefully measured.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

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

First Submitted

Initial submission to the registry

July 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

February 3, 2016

Status Verified

June 1, 2012

Enrollment Period

2.7 years

First QC Date

July 7, 2009

Last Update Submit

February 1, 2016

Conditions

Severe SepsisSeptic Shock

Keywords

C-reactive proteinprocalcitoninsepsisantibiotic therapy

Outcome Measures

Primary Outcomes (3)

  • Duration of antibiotic therapy for the first episode of infection

    28 days

  • Total antibiotic exposure days per 1,000 days

    28 days

  • Days alive without antibiotics

    28 days

Secondary Outcomes (10)

  • All cause 28-day mortality

    28 days

  • clinical cure rate

    28 days

  • Infection relapse (diagnosed less than 48h after antibiotic discontinuation)

    48 hours

  • Length of ICU stay

    Whole hospitalization

  • Nosocomial infection rate

    28 days

  • +5 more secondary outcomes

Study Arms (2)

Group 1 - C-reactive protein (CRP) guided ab therapy

EXPERIMENTAL

Intervention on antibiotic therapy will be based on circulating CRP levels

Other: C-reactive protein guided antibiotic therapy

Group 2 - procalcitonin (PCT) guided ab therapy

ACTIVE COMPARATOR

Intervention on antibiotic therapy will be based on circulating PCT levels

Other: Procalcitonin guided antibiotic therapy

Interventions

C-reactive protein guided antibiotic therapyOTHER

plasma CRP measurement to guide the duration of antibiotic therapy

Group 1 - C-reactive protein (CRP) guided ab therapy
Procalcitonin guided antibiotic therapyOTHER

plasma PCT measurement to guide the duration of antibiotic therapy

Group 2 - procalcitonin (PCT) guided ab therapy

Eligibility Criteria

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

You may qualify if:

  • age \> 17 years
  • patients in intensive care unit
  • signed informed consent
  • suspected or confirmed severe sepsis or septic shock

You may not qualify if:

  • Infections caused by Listeria spp, Legionella pneumophilia, Mycobacterium tuberculosis
  • Bacteremia due S. aureus
  • Infections requiring prolonged therapies, such as endocarditis, cerebral abscess, chronic osteomyelitis
  • Suspected or confirmed infection caused by virus, parasites
  • Infections caused by P. aeruginosa ou A. baumannii
  • Severe immunosuppression (ex: AIDS, post bone-marrow transplant,cystic fibrosis)
  • Traumatism latest five days
  • Surgery latest 5 days
  • Carcinoid tumor, lung cancer, medullary thyroid cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas - Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Location

Related Publications (1)

  • Oliveira CF, Botoni FA, Oliveira CR, Silva CB, Pereira HA, Serufo JC, Nobre V. Procalcitonin versus C-reactive protein for guiding antibiotic therapy in sepsis: a randomized trial. Crit Care Med. 2013 Oct;41(10):2336-43. doi: 10.1097/CCM.0b013e31828e969f.

    PMID: 23921272DERIVED

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Vandack A Nobre, PhD

    Medical School of the Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

  • Carolina F Oliveira, MD

    Idem

    STUDY CHAIR

  • Fernando A Botoni, PhD

    Idem

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, PhD

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 8, 2009

Study Start

September 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

February 3, 2016

Record last verified: 2012-06

Data Sharing

IPD Sharing
Will share

Results published in the Critical Care Medicine, 2013

Locations

BR(1)