Community-acquired Pneumonia Clinical Trial
— CAP-MarkerOfficial title:
Use of Procalcitonin (PCT) and C-reactive Protein (CRP) to Guide Antibiotic Therapy in Community Acquired Pneumonia: a Randomized Controlled Trial
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 |
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.
Status | Withdrawn |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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clínicas - Universidade Federal de Minas Gerais | Belo Horizonte | Minas Gerais |
Lead Sponsor | Collaborator |
---|---|
Federal University of Minas Gerais |
Brazil,
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 |
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