NCT01018199

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 community-acquired pneumonia. Therefore, the safety of this intervention will be carefully measured.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

November 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
6.1 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

February 3, 2016

Status Verified

March 1, 2012

Enrollment Period

2.6 years

First QC Date

November 20, 2009

Last Update Submit

February 1, 2016

Conditions

Community-acquired Pneumonia

Keywords

C-reactive proteinprocalcitonincommunity-acquired pneumoniaantibiotic 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)

    28 days

  • Length of hospitalization stay

    Whole hospitalization

  • In-hospital mortality

    28 days

  • +5 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL

Intervention on antibiotic therapy will be based on circulating RCP levels

Other: CRP

Group 2 - procalcitonin (PCT) guided antibiotic therapy

ACTIVE COMPARATOR

Intervention on antibiotic therapy will be based on circulating PCT levels

Other: PCT

Interventions

CRPOTHER

C-reactive protein guided antibiotic therapy plasma CRP measurement to guide the duration of antibiotic therapy

Group 1- C-reactive protein (CRP) guided antibiotic therapy
PCTOTHER

Procalcitonin guided antibiotic therapy plasma PCT measurement to guide the duration of antibiotic therapy

Group 2 - procalcitonin (PCT) guided antibiotic therapy

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • Signed informed consent
  • Suspected or confirmed community-acquired pneumonia

You may not qualify if:

  • Nosocomial pneumonia: development of symptoms after 48 hours of admission to the Emergency Department, or within 14 days after hospital discharge
  • Patients with lung cancer confirmed strongly suspected.
  • Patients with severe immunosuppression, such as severe neutropenia (\<500 neutrófilos/mm3), use of corticosteroids in doses above 0.5 mg / kg / day of prednisone or equivalent for at least 2 weeks, transplantation of solid organs or cells hematopoietic, use of immunosuppressants for any other reason (eg. azathioprine or cyclosporine), hipogamagloulinemia
  • Patients with asplenia in any order
  • Pregnant
  • Patients with known HIV infection
  • Stay indicated only for social reasons
  • Patients on antibiotics for any other reason
  • Patients with multiple trauma, burns or surgery grid size in the last 5 days

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

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Vandack A Nobre, PhD

    Medical School of the Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

  • Karla F Finotti, MD

    Medical School of the Federal University of Minas Gerais

    STUDY CHAIR
0

Study Design

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

Study Record Dates

First Submitted

November 20, 2009

First Posted

November 23, 2009

Study Start

January 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

February 3, 2016

Record last verified: 2012-03

Locations

BR(1)