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Changes in the profile of patients assisted by the hospital
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1- C-reactive protein (CRP) guided antibiotic therapy | Experimental | Intervention on antibiotic therapy will be based on circulating RCP levels |
|
| Group 2 - procalcitonin (PCT) guided antibiotic therapy | Active Comparator | Intervention on antibiotic therapy will be based on circulating PCT levels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRP | Other | C-reactive protein guided antibiotic therapy plasma CRP measurement to guide the duration of antibiotic therapy |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vandack A Nobre, PhD | Medical School of the Federal University of Minas Gerais | Principal Investigator |
| Karla F Finotti, MD | Medical School of the Federal University of Minas Gerais | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClÃnicas - Universidade Federal de Minas Gerais | Belo Horizonte | Minas Gerais | Brazil |
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| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| PCT | Other | Procalcitonin guided antibiotic therapy plasma PCT measurement to guide the duration of antibiotic therapy |
|
| 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 |
| D012140 |
| Respiratory Tract Diseases |