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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01018199
Recruitment Status : Withdrawn (Changes in the profile of patients assisted by the hospital)
First Posted : November 23, 2009
Last Update Posted : February 3, 2016
Information provided by (Responsible Party):
Vandack Alencar Nobre, Federal University of Minas Gerais

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.

Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Other: CRP Other: PCT Not Applicable

Detailed Description:


• 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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
Study Start Date : January 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Duration of antibiotic therapy for the first episode of infection [ Time Frame: 28 days ]
  2. Total antibiotic exposure days per 1,000 days [ Time Frame: 28 days ]
  3. Days alive without antibiotics [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. All cause 28-day mortality [ Time Frame: 28 days ]
  2. clinical cure rate [ Time Frame: 28 days ]
  3. Infection relapse (diagnosed less than 48h after antibiotic discontinuation) [ Time Frame: 28 days ]
  4. Length of hospitalization stay [ Time Frame: Whole hospitalization ]
  5. In-hospital mortality [ Time Frame: 28 days ]
  6. Nosocomial infection rate [ Time Frame: 28 days ]
  7. Nosocomial superinfection (diagnosed more than 48hous after discontinuation of the antibiotic therapy given to the first episode of infection) [ Time Frame: 28 days ]
  8. Isolation of resistant bacteria [ Time Frame: 28 days ]
  9. All cause 90-day mortality [ Time Frame: 90 days ]
  10. costs of hospitalization [ Time Frame: Whole hospitalization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01018199

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Hospital das Clínicas - Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Sponsors and Collaborators
Federal University of Minas Gerais
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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

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Responsible Party: Vandack Alencar Nobre, Associate Professor, PhD, Federal University of Minas Gerais Identifier: NCT01018199     History of Changes
Other Study ID Numbers: UFMG-PCT
First Posted: November 23, 2009    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: March 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Vandack Alencar Nobre, Federal University of Minas Gerais:
C-reactive protein
community-acquired pneumonia
antibiotic therapy
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents