Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 468
- Locations
- 3
- Primary Endpoint
- Length of antibiotic treatment
Study Overview
Brief Summary
The purpose of this study is to evaluate two different treatment strategies in patients admitted to hospital with Community Acquired Pneumonia. The investigators hypothesize treatment according to both procalcitonin (PCT) and C-reactive protein (CRP) will be effective in reducing the length of antibiotic treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female patients with a diagnosis of CAP and all criteria listed below:
- •Age 18 or above, no upper age limit will be employed.
- •Patients must require hospitalisation.
- •Clinical presentation of an acute illness with one or more of the following symptoms:
- •Temperature ≥ 38.0 ⁰C (100.4°F)
- •Cough (with or without expectoration of sputum)
- •Malaise or fatigue
- •Gastro-intestinal symptoms
- •Rales, rhonchi or wheezing
- •Egophony or bronchial breath sounds
- •New consolidation(s) on the chest radiograph.
- •Written informed consent obtained.
- •(Pre-event) Life expectancy > 30 days
Exclusion Criteria
- •Subjects presenting with any of the following will not be included in the study:
- •(Severe) immunosuppression (e.g. HIV infection, chemotherapy, use of immunosuppressants).
- •Active neoplastic disease.
- •Obstruction pneumonia (e.g. from lung cancer).
- •Aspiration pneumonia.
- •Pneumonia that developed within 8 days after hospital discharge.
- •Unable and/or unlikely to comprehend and/or follow the protocol.
- •Pregnant and/or lactating women.
- •Other infection that requires treatment with antibiotics
Arms & Interventions
Common clinical practice
Treatment according to current guidelines. Often a 7 day course of antibiotics. Initial treatment should be broad spectrum antibiotics and can be narrowed down if a specific pathogen is identified.
Intervention: Treatment according to current guidelines (Drug)
CRP-guided treatment
Treatment according to CRP levels. Patients will be started on broad spectrum antibiotics for at least 3 days, treatment can be switched to small-spectrum antibiotics if a specific pathogen is identified. From day 4 to 7 daily blood tests will be performed in order to evaluate whether or not treatment can be discontinued. If treatment is discontinued, no more blood tests will be performed.
Intervention: Discontinuation of treatment according to CRP levels (Drug)
PCT guided treatment
Treatment according to PCT levels. Patients will be started on broad spectrum antibiotics for at least 3 days, treatment can be switched to small-spectrum antibiotics if a specific pathogen is identified. From day 4 to 7 daily blood tests will be performed in order to evaluate whether or not treatment can be discontinued. If treatment is discontinued, no more blood tests will be performed.
Intervention: Discontinuation of treatment according to PCT levels (Drug)
Outcomes
Primary Outcomes
Length of antibiotic treatment
Time Frame: End of the study
Secondary Outcomes
- Length of stay(End of the study)
- Clinical response(End of the study)
- 30-day mortality(End of the study, periodically by the DSMB)
- Time to clinical stability(End of the study)
- Relapse rate(End of the study)
Investigators
W.G.Boersma
MSc, MD, PhD
Medical Center Alkmaar