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

Use of Procalcitonin (PCT) and C-reactive Protein (CRP) to Guide Antibiotic Therapy in Community Acquired Pneumonia: a Randomized Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: Other: CRP; Other: PCT

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:

1. The patients is clinically stable, without signs of active infection
2. CRP group: a relative reduction of 50% in baseline CRP levels, or a value lower than 25mg/dl is reached.
3. 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil
      • Hospital das Clínicas - Universidade Federal de Minas Gerais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1- C-reactive protein (CRP) guided antibiotic therapy; Intervention on antibiotic therapy will be based on circulating RCP levels	Other: CRP; C-reactive protein guided antibiotic therapy plasma CRP measurement to guide the duration of antibiotic therapy
ACTIVE_COMPARATOR: Group 2 - procalcitonin (PCT) guided antibiotic therapy; Intervention on antibiotic therapy will be based on circulating PCT levels	Other: PCT; Procalcitonin guided antibiotic therapy plasma PCT measurement to guide the duration of antibiotic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Principal Investigator: Vandack A Nobre, PhD, Medical School of the Federal University of Minas Gerais; Study Chair: Karla F Finotti, MD, Medical School of the Federal University of Minas Gerais

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ANTICIPATED): August 1, 2018
• Study Completion (ANTICIPATED): August 1, 2018

Study Registration Dates

• First Submitted: November 20, 2009
• First Submitted That Met QC Criteria: November 20, 2009
• First Posted (ESTIMATE): November 23, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): February 3, 2016
• Last Update Submitted That Met QC Criteria: February 1, 2016
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: procalcitonin; C-reactive protein; antibiotic therapy; community-acquired pneumonia
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: UFMG-PCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED