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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Community-acquired Pneumonia

Intervention / Treatment
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* Other: CRP
* Other: PCT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1- C-reactive protein (CRP) guided antibiotic therapy<br>Intervention on antibiotic therapy will be based on circulating RCP levels | Other: CRP<br>* C-reactive protein guided antibiotic therapy plasma CRP measurement to guide the duration of antibiotic therapy<br>|
| Active Comparator: Group 2 - procalcitonin (PCT) guided antibiotic therapy<br>Intervention on antibiotic therapy will be based on circulating PCT levels | Other: PCT<br>* Procalcitonin guided antibiotic therapy plasma PCT measurement to guide the duration of antibiotic therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| All cause 28-day mortality |  | 28 days | 
| clinical cure rate |  | 28 days | 
| Infection relapse (diagnosed less than 48h after antibiotic discontinuation) |  | 28 days | 
| Length of hospitalization stay |  | Whole hospitalization | 
| In-hospital mortality |  | 28 days | 
| Nosocomial infection rate |  | 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 | 
| All cause 90-day mortality |  | 90 days | 
| costs of hospitalization |  | Whole hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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C-reactive protein, procalcitonin, community-acquired pneumonia, antibiotic therapy