Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study)
REDUCE
1 other identifier
interventional
468
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2013
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2013
CompletedFirst Posted
Study publicly available on registry
October 17, 2013
CompletedStudy Start
First participant enrolled
December 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2017
CompletedApril 5, 2022
March 1, 2022
3.1 years
September 30, 2013
March 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Length of antibiotic treatment
End of the study
Secondary Outcomes (5)
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
Study Arms (3)
Common clinical practice
ACTIVE COMPARATORTreatment 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
EXPERIMENTALTreatment 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
EXPERIMENTALTreatment 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.
Interventions
The cutoff point is a CRP below 100 mg/L and a reduction to 50% of the initial value.
The cutoff point is a PCT below 0.25 mcg/L or a reduction to 10% of the initial value.
Often a 7 days course of antibiotics, treatment may be extended if the attending physician deems it necessary.
Eligibility Criteria
You may qualify if:
- 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)
- Dyspnoea
- Cough (with or without expectoration of sputum)
- Chest pain
- Malaise or fatigue
- Myalgia
- Gastro-intestinal symptoms
- Rales, rhonchi or wheezing
- Egophony or bronchial breath sounds
- New consolidation(s) on the chest radiograph.
- Written informed consent obtained.
- +1 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical Center Alkmaarlead
- Foreest Medical Schoolcollaborator
- Pulmosciencecollaborator
Study Sites (3)
Medical Centre Alkmaar
Alkmaar, North Holland, 1815JD, Netherlands
Slotervaart Hospital
Amsterdam, North Holland, 1006BK, Netherlands
ISALA clinics
Zwolle, Overijssel, 8025 AB, Netherlands
Related Publications (2)
Hessels L, Duijkers R, Schoorl M, Terpstra L, Thijs W, Boersma W. The Value of Soluble Urokinase Plasminogen Activator Receptor (suPAR) as Predictive Tool in Hospitalised Patients With Community-Acquired Pneumonia (CAP). Clin Respir J. 2025 Jun;19(6):e70089. doi: 10.1111/crj.70089.
PMID: 40523722DERIVEDDuijkers R, Prins HJ, Kross M, Snijders D, van den Berg JWK, Werkman GM, van der Veen N, Schoorl M, Bonten MJM, van Werkhoven CH, Boersma WG. Biomarker guided antibiotic stewardship in community acquired pneumonia: A randomized controlled trial. PLoS One. 2024 Aug 20;19(8):e0307193. doi: 10.1371/journal.pone.0307193. eCollection 2024.
PMID: 39163362DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ruud Duijkers, MSc, MD
Medisch Centrum Alkmaar
- PRINCIPAL INVESTIGATOR
Wim G Boersma, MD, PhD, MSc
Medisch Centrum Alkmaar
- STUDY CHAIR
Dominic Snijders, MSc, PhD, MD
Slotervaart ziekenhuis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc, MD, PhD
Study Record Dates
First Submitted
September 30, 2013
First Posted
October 17, 2013
Study Start
December 5, 2013
Primary Completion
January 20, 2017
Study Completion
January 20, 2017
Last Updated
April 5, 2022
Record last verified: 2022-03