search
Back to results

Procalcitonin Versus C-reactive Protein to Guide Therapy in Community Acquired Pneumonia (CAP-Marker)

Primary Purpose

Community-acquired Pneumonia

Status
Withdrawn
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CRP
PCT
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring C-reactive protein, procalcitonin, community-acquired pneumonia, antibiotic therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Signed informed consent
  3. Suspected or confirmed community-acquired pneumonia

Exclusion Criteria:

  1. Nosocomial pneumonia: development of symptoms after 48 hours of admission to the Emergency Department, or within 14 days after hospital discharge
  2. Patients with lung cancer confirmed strongly suspected.
  3. 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
  4. Patients with asplenia in any order
  5. Pregnant
  6. Patients with known HIV infection
  7. Stay indicated only for social reasons
  8. Patients on antibiotics for any other reason
  9. Patients with multiple trauma, burns or surgery grid size in the last 5 days

Sites / Locations

  • Hospital das Clínicas - Universidade Federal de Minas Gerais

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Group 2 - procalcitonin (PCT) guided antibiotic therapy

Arm Description

Intervention on antibiotic therapy will be based on circulating RCP levels

Intervention on antibiotic therapy will be based on circulating PCT levels

Outcomes

Primary Outcome Measures

Duration of antibiotic therapy for the first episode of infection
Total antibiotic exposure days per 1,000 days
Days alive without antibiotics

Secondary Outcome Measures

All cause 28-day mortality
clinical cure rate
Infection relapse (diagnosed less than 48h after antibiotic discontinuation)
Length of hospitalization stay
In-hospital mortality
Nosocomial infection rate
Nosocomial superinfection (diagnosed more than 48hous after discontinuation of the antibiotic therapy given to the first episode of infection)
Isolation of resistant bacteria
All cause 90-day mortality
costs of hospitalization

Full Information

First Posted
November 20, 2009
Last Updated
February 1, 2016
Sponsor
Federal University of Minas Gerais
search

1. Study Identification

Unique Protocol Identification Number
NCT01018199
Brief Title
Procalcitonin Versus C-reactive Protein to Guide Therapy in Community Acquired Pneumonia
Acronym
CAP-Marker
Official Title
Use of Procalcitonin (PCT) and C-reactive Protein (CRP) to Guide Antibiotic Therapy in Community Acquired Pneumonia: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Changes in the profile of patients assisted by the hospital
Study Start Date
January 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Methods • Patients and settings: All adult (> 18 years old) patients with diagnosis community-acquired pneumonia will receive initial antibiotic therapy based on local guidelines and susceptibility patterns, according to the decision of the treating physician.Patients will be randomly assigned to one of two groups, which respectively include PCR and PCT clinical procedure protocol. Randomization will be done using a table of random numbers generated by computer. For practical reasons the doctors treating the patients in question have science group in which the patient was included. Patients included in the two groups will have baseline assessment during the first day of study: Clinical evaluation of basic Start of antibiotic therapy Inclusion in the study Randomization (after signing the Informed Consent) Interventions: They will have circulating PCT and CRP levels measured at baseline and days 1,2,3 e 5 in both groups. Group 1 - CRP group: the duration of antibiotic therapy will be based on circulating CRP levels. Group 2 - PCT group: the duration of antibiotic therapy will be based on circulating PCT levels. Patients enrolled in the study will undergo daily measurements of plasma CRP (Dry Chemistry - Johnsons & Johnsons) and PCT (BRAHMS PCT VIDAS) levels up to day 5, and then, every 48hr in patients remaining in the ICU, and every 5 days in those transferred to the ward. Patients will be followed up 28 days, or until death or hospital transference, which comes first. PCT and CRP results will be released in sealed envelopes. During the study period, only the results corresponding to the patient randomization group will be open; i.e., CRP for CRP group patients and PCT for PCT group patients. Criteria for antibiotic interruption: The investigators will propose the interruption of antibiotics if: The patients is clinically stable, without signs of active infection CRP group: a relative reduction of 50% in baseline CRP levels, or a value lower than 25mg/dl is reached. PCT group: a relative reduction of 90% in baseline PCT levels, or if a absolute value lower than 0.1 ng/ml is reached. The final decision regarding antibiotic therapy will be always let to the discretion of the treating physician.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
Keywords
C-reactive protein, procalcitonin, community-acquired pneumonia, antibiotic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1- C-reactive protein (CRP) guided antibiotic therapy
Arm Type
Experimental
Arm Description
Intervention on antibiotic therapy will be based on circulating RCP levels
Arm Title
Group 2 - procalcitonin (PCT) guided antibiotic therapy
Arm Type
Active Comparator
Arm Description
Intervention on antibiotic therapy will be based on circulating PCT levels
Intervention Type
Other
Intervention Name(s)
CRP
Intervention Description
C-reactive protein guided antibiotic therapy plasma CRP measurement to guide the duration of antibiotic therapy
Intervention Type
Other
Intervention Name(s)
PCT
Intervention Description
Procalcitonin guided antibiotic therapy plasma PCT measurement to guide the duration of antibiotic therapy
Primary Outcome Measure Information:
Title
Duration of antibiotic therapy for the first episode of infection
Time Frame
28 days
Title
Total antibiotic exposure days per 1,000 days
Time Frame
28 days
Title
Days alive without antibiotics
Time Frame
28 days
Secondary Outcome Measure Information:
Title
All cause 28-day mortality
Time Frame
28 days
Title
clinical cure rate
Time Frame
28 days
Title
Infection relapse (diagnosed less than 48h after antibiotic discontinuation)
Time Frame
28 days
Title
Length of hospitalization stay
Time Frame
Whole hospitalization
Title
In-hospital mortality
Time Frame
28 days
Title
Nosocomial infection rate
Time Frame
28 days
Title
Nosocomial superinfection (diagnosed more than 48hous after discontinuation of the antibiotic therapy given to the first episode of infection)
Time Frame
28 days
Title
Isolation of resistant bacteria
Time Frame
28 days
Title
All cause 90-day mortality
Time Frame
90 days
Title
costs of hospitalization
Time Frame
Whole hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Signed informed consent Suspected or confirmed community-acquired pneumonia Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vandack A Nobre, PhD
Organizational Affiliation
Medical School of the Federal University of Minas Gerais
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karla F Finotti, MD
Organizational Affiliation
Medical School of the Federal University of Minas Gerais
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital das Clínicas - Universidade Federal de Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Procalcitonin Versus C-reactive Protein to Guide Therapy in Community Acquired Pneumonia

We'll reach out to this number within 24 hrs