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

Community Acquired Pneumonia Clinical Trial

— REDUCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964495
• Other study ID #: 1-Duijkers
• Status: Completed
• Phase: N/A
• Start date: December 5, 2013
• Est. completion date: January 20, 2017

Study information

• Verified date: March 2022
• Source: Medical Center Alkmaar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 468
• Est. completion date: January 20, 2017
• Est. primary completion date: January 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 °C (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

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Pneumonia

Intervention

Drug:
• 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.
• 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.
• Treatment according to current guidelines
Often a 7 days course of antibiotics, treatment may be extended if the attending physician deems it necessary.

Locations

Country	Name	City	State
Netherlands	Medical Centre Alkmaar	Alkmaar	Noord Holland
Netherlands	Slotervaart Hospital	Amsterdam	Noord Holland
Netherlands	ISALA clinics	Zwolle	Overijssel

Sponsors (3)

Lead Sponsor	Collaborator
Medical Center Alkmaar	Foreest Medical School, Pulmoscience

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of antibiotic treatment		End of the study
Secondary	Length of stay		End of the study
Secondary	Clinical response	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.	End of the study
Secondary	30-day mortality	All cause	End of the study, periodically by the DSMB
Secondary	Time to clinical stability	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.	End of the study
Secondary	Relapse rate		End of the study