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

Medical Center Alkmaar

Status: Completed

Conditions: Community Acquired Pneumonia

Treatments: Drug: Treatment according to current guidelines; Drug: Discontinuation of treatment according to PCT levels; Drug: Discontinuation of treatment according to CRP levels

Study type: Interventional

Funder types: Other

Identifiers

NCT01964495

1-Duijkers

Details and patient eligibility

About

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.

Enrollment: 468 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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468 participants in 3 patient groups

Common clinical practice

Active Comparator group

Description:

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.

Treatment:

Drug: Treatment according to current guidelines

CRP-guided treatment

Experimental group

Description:

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.

Treatment:

Drug: Discontinuation of treatment according to CRP levels

PCT guided treatment

Experimental group

Description:

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.

Treatment:

Drug: Discontinuation of treatment according to PCT levels