Community Acquired PneumoniaREDUCENCT01964495
Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study)
A study testing Discontinuation of treatment according to CRP levels, Discontinuation of treatment according to PCT levels and Treatment according to current guidelines in people with Community Acquired Pneumonia, run by Medical Center Alkmaar at 3 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia
- What is being tested?
- Discontinuation of treatment according to CRP levels, Discontinuation of treatment according to PCT levels and Treatment according to current guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 3 sitesNetherlands
- Study dates
- 5 Dec 2013to 20 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- (Pre-event) Life expectancy > 30 days
Who cannot join
- 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.
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- Unable and/or unlikely to comprehend and/or follow the protocol.
- Pregnant and/or lactating women.
- Other infection that requires treatment with antibiotics
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Medical Centre Alkmaar
Alkmaar, North Holland, 1815JD
Slotervaart Hospital
Amsterdam, North Holland, 1006BK
ISALA clinics
Zwolle, Overijssel, 8025 AB
About this study
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.
- Conditions
- Community Acquired Pneumonia
- Being tested
- Discontinuation of treatment according to CRP levels, Discontinuation of treatment according to PCT levels, Treatment according to current guidelines
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of treatment according to CRP levelsDrug
Also called Broad spectrum antibiotics, Small spectrum antibiotics
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 levelsDrug
Also called Broad spectrum antibiotics, Small spectrum antibiotics
The cutoff point is a PCT below 0.25 mcg/L or a reduction to 10% of the initial value.
Treatment according to current guidelinesDrug
Also called Broad spectrum antibiotics, Small spectrum antibiotics
Often a 7 days course of antibiotics, treatment may be extended if the attending physician deems it necessary.
| Study group | Role | What they receive |
|---|---|---|
| Common clinical practice | Active comparator | 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. Receives: Drug: Treatment according to current guidelines |
| CRP-guided treatment | Experimental | 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. Receives: Drug: Discontinuation of treatment according to CRP levels |
| PCT guided treatment | Experimental | 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. Receives: Drug: Discontinuation of treatment according to PCT levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of antibiotic treatment
Measured: End of the study
Secondary outcomes (5)
Length of stay
Measured: End of the study
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.
Measured: End of the study
30-day mortality
All cause
Measured: End of the study, periodically by the DSMB
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.
Measured: End of the study
Relapse rate
Measured: End of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study start5 Dec 2013
- Primary completion20 Jan 2017
- Study completion20 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Center Alkmaar
- Sponsor type
- University, hospital or other
- Collaborators
- Foreest Medical School, Pulmoscience
- Responsible party
- Principal investigator, W.G.Boersma, Medical Center Alkmaar
- Investigators
- Ruud Duijkers, MSc, MD, Study director, Medisch Centrum AlkmaarWim G Boersma, MD, PhD, MSc, Principal investigator, Medisch Centrum AlkmaarDominic Snijders, MSc, PhD, MD, Study chair, Slotervaart ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964495
- Sponsor's protocol ID
- 1-Duijkers
- Acronym
- REDUCE
- Status last verified
- Mar 2022
- First submitted
- 30 Sep 2013
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40523722Duijkers 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.
PubMed 39163362
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study)
- ClinicalTrials.gov ID
- NCT01964495
- Acronym / sponsor ID
- REDUCE / 1-Duijkers
- Conditions
- Community Acquired Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- Medical Center AlkmaarUniversity, hospital or other
- Collaborators
- Foreest Medical School, Pulmoscience
- Study start
- 5 Dec 2013 (actual)
- Primary completion
- 20 Jan 2017 (actual)
- Study completion
- 20 Jan 2017 (actual)
- First posted
- 17 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Common clinical practice | Active comparator | Drug: Treatment according to current guidelinesTreatment 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 | Experimental | Drug: Discontinuation of treatment according to CRP levelsTreatment 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 | Experimental | Drug: Discontinuation of treatment according to PCT levelsTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- New consolidation(s) on the chest radiograph.
- Written informed consent obtained.
Key exclusion criteria (9 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinuation of treatment according to CRP levelsAlso: Broad spectrum antibiotics, Small spectrum antibioticsThe cutoff point is a CRP below 100 mg/L and a reduction to 50% of the initial value. | Drug | CRP-guided treatment |
| Discontinuation of treatment according to PCT levelsAlso: Broad spectrum antibiotics, Small spectrum antibioticsThe cutoff point is a PCT below 0.25 mcg/L or a reduction to 10% of the initial value. | Drug | PCT guided treatment |
| Treatment according to current guidelinesAlso: Broad spectrum antibiotics, Small spectrum antibioticsOften a 7 days course of antibiotics, treatment may be extended if the attending physician deems it necessary. | Drug | Common clinical practice |
Primary outcome
Length of antibiotic treatment
Time frame: End of the study
5 secondary outcomes
Length of stay
Time frame: End of the study
Clinical response
Time frame: End of the study
30-day mortality
Time frame: End of the study, periodically by the DSMB
Time to clinical stability
Time frame: End of the study
Relapse rate
Time frame: End of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Derived from this study: PubMed 40523722Hessels 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.
- Derived from this study: PubMed 39163362Duijkers 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.
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Local Antibiotic Delivery for Community Acquired Pneumonia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruud Duijkers, MSc, MD study director
Medisch Centrum Alkmaar
Wim G Boersma, MD, PhD, MSc principal investigator
Medisch Centrum Alkmaar
Dominic Snijders, MSc, PhD, MD study chair
Slotervaart ziekenhuis
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discontinuation of treatment according to CRP levels, Discontinuation of treatment according to PCT levels and Treatment according to current guidelines in people with Community Acquired Pneumonia, run by Medical Center Alkmaar at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of antibiotic treatment (time frame: End of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01964495, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.