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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2012 by Federal University of Minas Gerais
Sponsor:
Information provided by (Responsible Party):
Vandack Alencar Nobre, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT01018199
First received: November 20, 2009
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Community-acquired Pneumonia
Other: CRP
Other: PCT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Use of Procalcitonin (PCT) and C-reactive Protein (CRP) to Guide Antibiotic Therapy in Community Acquired Pneumonia: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • Duration of antibiotic therapy for the first episode of infection [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Total antibiotic exposure days per 1,000 days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Days alive without antibiotics [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All cause 28-day mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • clinical cure rate [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Infection relapse (diagnosed less than 48h after antibiotic discontinuation) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Length of hospitalization stay [ Time Frame: Whole hospitalization ] [ Designated as safety issue: No ]
  • In-hospital mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Nosocomial infection rate [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Nosocomial superinfection (diagnosed more than 48hous after discontinuation of the antibiotic therapy given to the first episode of infection) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Isolation of resistant bacteria [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • All cause 90-day mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • costs of hospitalization [ Time Frame: Whole hospitalization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018199

Contacts
Contact: Karla F Finotti, MD 553198192309 karlafinotti@yahoo.com.br
Contact: Vandack A Nobre A Nobre, PhD 553198310004 vandack@gmail.com

Locations
Brazil
Hospital das Clínicas - Universidade Federal de Minas Gerais Not yet recruiting
Belo Horizonte, Minas Gerais, Brazil
Contact: Karla F Finotti, MD    553198192309    karlafinotti@yahoo.com.br   
Contact: Vandack A Nobre, PhD    559198310004    vandack@gmail.com   
Sub-Investigator: Karla F Finotti, MD         
Principal Investigator: Vandack A Nobre, PhD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Vandack Alencar Nobre, Associate Professor, PhD, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01018199     History of Changes
Other Study ID Numbers: UFMG-PCT
Study First Received: November 20, 2009
Last Updated: March 1, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Minas Gerais:
C-reactive protein
procalcitonin
community-acquired pneumonia
antibiotic therapy

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 18, 2014