Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

468 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-05

Study Completion Date

2017-01-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Community Acquired Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Treatment according to current guidelines

Intervention Type DRUG

Often a 7 days course of antibiotics, treatment may be extended if the attending physician deems it necessary.

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.

Group Type EXPERIMENTAL

Discontinuation of treatment according to CRP levels

Intervention Type DRUG

The cutoff point is a CRP below 100 mg/L and a reduction to 50% of the initial value.

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.

Group Type EXPERIMENTAL

Discontinuation of treatment according to PCT levels

Intervention Type DRUG

The cutoff point is a PCT below 0.25 mcg/L or a reduction to 10% of the initial value.

Interventions

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Discontinuation of treatment according to CRP levels

The cutoff point is a CRP below 100 mg/L and a reduction to 50% of the initial value.

Intervention Type DRUG

Discontinuation of treatment according to PCT levels

The cutoff point is a PCT below 0.25 mcg/L or a reduction to 10% of the initial value.

Intervention Type DRUG

Treatment according to current guidelines

Often a 7 days course of antibiotics, treatment may be extended if the attending physician deems it necessary.

Intervention Type DRUG

Other Intervention Names

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Broad spectrum antibiotics Small spectrum antibiotics Broad spectrum antibiotics Small spectrum antibiotics Broad spectrum antibiotics Small spectrum antibiotics

Eligibility Criteria

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Inclusion Criteria

Male and female patients with a diagnosis of CAP and all criteria listed below:

1. Age 18 or above, no upper age limit will be employed.
2. Patients must require hospitalisation.
3. Clinical presentation of an acute illness with one or more of the following symptoms:

1. Temperature ≥ 38.0 ⁰C (100.4°F)
2. Dyspnoea
3. Cough (with or without expectoration of sputum)
4. Chest pain
5. Malaise or fatigue
6. Myalgia
7. Gastro-intestinal symptoms
8. Rales, rhonchi or wheezing
9. Egophony or bronchial breath sounds
4. New consolidation(s) on the chest radiograph.
5. Written informed consent obtained.
6. (Pre-event) Life expectancy \> 30 days

Exclusion Criteria

Subjects presenting with any of the following will not be included in the study:

1. (Severe) immunosuppression (e.g. HIV infection, chemotherapy, use of immunosuppressants).
2. Active neoplastic disease.
3. Obstruction pneumonia (e.g. from lung cancer).
4. Aspiration pneumonia.
5. Pneumonia that developed within 8 days after hospital discharge.
6. Unable and/or unlikely to comprehend and/or follow the protocol.
7. Pregnant and/or lactating women.
8. Other infection that requires treatment with antibiotics

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No