CAP-MarkerUse of Procalcitonin (PCT) and C-reactive Protein (CRP) to Guide Antibiotic Therapy in Community Acquired Pneumonia: a Randomized Controlled Trial
CRP
+ PCT
Community-Acquired Pneumonia+3
+ Infections
+ Pneumonia
Treatment Study
Summary
Study start date: January 1, 2016
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Hospital das Clínicas - Universidade Federal de Minas Gerais
Belo Horizonte, BrazilOpen Hospital das Clínicas - Universidade Federal de Minas Gerais in Google Maps