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

Not Applicable

Completed

• Conditions: Community Acquired Pneumonia
• Interventions: Drug: Treatment according to current guidelines; Drug: Discontinuation of treatment according to CRP levels; Drug: Discontinuation of treatment according to PCT levels

• Registration Number: NCT01964495
• Lead Sponsor: Medical Center Alkmaar

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2013-10-14
• Study First Posted: 2013-10-17
• Study Start: 2013-12-05
• Primary Completion: 2017-01-20
• Study Completion: 2017-01-20
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 468

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Common clinical practice	Treatment according to current guidelines	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.
CRP-guided treatment	Discontinuation of treatment according to CRP levels	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.
PCT guided treatment	Discontinuation of treatment according to PCT levels	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.

Primary Outcome Measures

Name	Time	Method
Length of antibiotic treatment	End of the study

Secondary Outcome Measures

Name	Time	Method
Length of stay	End of the study
Clinical response	End of the study	Cure - resolution or improvement of symptoms and clinical signs related to pneumonia without the need for additional or alternative antibiotic therapy; Failure - persistence or progression of all signs and symptoms of the acute process after randomisation or the development of a new pulmonary or extrapulmonary respiratory tract infection, or the progression of abnormalities on chest radiograph after randomisation, or death due to pneumonia, or the inability to complete the study owing to adverse events; Indeterminate - patient receives less than 80% of the study drug for reasons other than clinical failure, a concomitant infection outside the respiratory tract requiring antibiotic treatment, lost to follow-up, or death unrelated to the primary diagnosis.
30-day mortality	End of the study, periodically by the DSMB	All cause
Time to clinical stability	End of the study	Patients are considered clinically stable if they fulfill all of these criteria: Temperature equal to or below 37.8 degrees celsius, heart rate equal to or below 100 beats per minute, respiratory rate equal to or below 24 breaths per minute, systolic blood pressure equal to or above 90 mmHg, arterial oxygen saturation equal to or above 90 percent or pO2 equal to or above 60 mmHg on room air, ability to maintain oral intake, normal mental status.
Relapse rate	End of the study

Trial Locations

Locations (3)

ISALA clinics; 🇳🇱 Zwolle, Overijssel, Netherlands

Slotervaart Hospital; 🇳🇱 Amsterdam, Noord Holland, Netherlands

Medical Centre Alkmaar; 🇳🇱 Alkmaar, Noord Holland, Netherlands