An interventional study of CRP and PCT in Community-acquired Pneumonia, sponsored by Federal University of Minas Gerais. Withdrawn at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-03.
Sponsored by Federal University of Minas Gerais · Not applicable, Interventional, and Treatment
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.
Methods
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:
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 final decision regarding antibiotic therapy will be always let to the discretion of the treating physician.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
Browse Pneumonia studies →Federal University of Minas Gerais is the lead sponsor of 150 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intervention on antibiotic therapy will be based on circulating RCP levels
Other: CRP
Intervention on antibiotic therapy will be based on circulating PCT levels
Other: PCT
C-reactive protein guided antibiotic therapy plasma CRP measurement to guide the duration of antibiotic therapy
Procalcitonin guided antibiotic therapy plasma PCT measurement to guide the duration of antibiotic therapy
Duration of antibiotic therapy for the first episode of infection
Time frame: 28 days
Total antibiotic exposure days per 1,000 days
Time frame: 28 days
Days alive without antibiotics
Time frame: 28 days
All cause 28-day mortality
Time frame: 28 days
clinical cure rate
Time frame: 28 days
Infection relapse (diagnosed less than 48h after antibiotic discontinuation)
Time frame: 28 days
Length of hospitalization stay
Time frame: Whole hospitalization
In-hospital mortality
Time frame: 28 days
Nosocomial infection rate
Time frame: 28 days
Nosocomial superinfection (diagnosed more than 48hous after discontinuation of the antibiotic therapy given to the first episode of infection)
Time frame: 28 days
Isolation of resistant bacteria
Time frame: 28 days
All cause 90-day mortality
Time frame: 90 days
costs of hospitalization
Time frame: Whole hospitalization
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Federal University of Minas Gerais