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

Community-acquired Pneumonia Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01018199
• Other study ID #: UFMG-PCT
• Status: Withdrawn
• Phase: N/A
• First received: November 20, 2009
• Last updated: February 1, 2016
• Start date: January 2016
• Est. completion date: August 2018

Study information

• Verified date: March 2012
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Other:
• CRP
C-reactive protein guided antibiotic therapy plasma CRP measurement to guide the duration of antibiotic therapy
• PCT
Procalcitonin guided antibiotic therapy plasma PCT measurement to guide the duration of antibiotic therapy

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas - Universidade Federal de Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of antibiotic therapy for the first episode of infection		28 days	No
Primary	Total antibiotic exposure days per 1,000 days		28 days	No
Primary	Days alive without antibiotics		28 days	No
Secondary	All cause 28-day mortality		28 days	Yes
Secondary	clinical cure rate		28 days	Yes
Secondary	Infection relapse (diagnosed less than 48h after antibiotic discontinuation)		28 days	Yes
Secondary	Length of hospitalization stay		Whole hospitalization	No
Secondary	In-hospital mortality		28 days	Yes
Secondary	Nosocomial infection rate		28 days	Yes
Secondary	Nosocomial superinfection (diagnosed more than 48hous after discontinuation of the antibiotic therapy given to the first episode of infection)		28 days	Yes
Secondary	Isolation of resistant bacteria		28 days	Yes
Secondary	All cause 90-day mortality		90 days	Yes
Secondary	costs of hospitalization		Whole hospitalization	Yes