Community-acquired PneumoniaCAP-PACTNCT02604628
Increasing Community-acquired Pneumonia Protocol Adherence by Antibiotic Stewardship
A study testing Antibiotic Stewardship Intervention in people with Community-acquired Pneumonia, run by UMC Utrecht at 12 sites in Netherlands.
Trial summary
The purpose of this study is to determine the effect of a multifaceted antibiotic stewardship intervention on protocol adherence of moderate-severe community-acquired pneumonia. 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?
- Antibiotic Stewardship Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,084 participants
- Where
- 12 sitesNetherlands
- Study dates
- 1 Nov 2015to 12 Feb 2019
- 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
- Patients diagnosed with CAP who get admitted to a non-ICU department are eligible for inclusion.
Who cannot join
- Patients aged below 18 years
- Residence in a nursing home or long-term care facility in the last 14 days
- Patients hospitalized in an acute care hospital for two or more days in the last 14 days
- Patients with a history of Cystic Fibrosis
- Patients with immunodeficiency, defined as having one or more of the following criteria:
- HIV infection with a last CD4 count of <300//μL
Show all 10Show fewer
- Cytotoxic chemotherapy or radiotherapy in the previous 3 months
- Chronic hemodialysis > 3 months
- History of receiving an organ or bone marrow transplant
- Using immunosuppressive therapy, include corticosteroid treatment only when dosage is high (>0,5mg/kg/day) for a longer period of time (>14 days)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Netherlands12 sites
Noordwest Ziekenhuisgroep
Alkmaar
Wilhelmina hospital
Assen
Amphia hospital
Breda
Catharina hospital
Eindhoven
Medisch Spectrum Twente
Enschede
Ziekehuisgroep Twente
Hengelo
Tergooi
Hilversum
Erasmus MC
Rotterdam
Diakonessenhuis
Utrecht
UMC Utrecht
Utrecht
Maxima Medisch Centrum
Veldhoven
Langeland hospital
Zoetermeer
About this study
Official title: Community-acquired Pneumonia: Increasing Protocol Adherence by Antibiotic Stewardship in a Stepped Wedge Cluster- Randomized Trial
The purpose of this study is to determine the effect of a multifaceted antibiotic stewardship intervention on protocol adherence of moderate-severe community-acquired pneumonia.
Read the detailed description
The purpose of the study is to show a decrease in broad-spectrum antibiotics with a non-inferiority in 90-day mortality. Hospitals with a pre-intervention protocol adherence of >70% are excluded from the primary analysis. Primary analysis will be done with a mixed effects model with a random effects for clusters and time. Crude outcomes and outcomes adjusted for potential confounders will be reported. Primary analysis will be tested one-sided for a decrease in mortality. Secondary analysis to test two-sided for mortality will be performed.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Antibiotic Stewardship Intervention
- Keywords
- Pneumonia, Antibiotic Stewardship, Stepped wedge, Antibiotic
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic Stewardship InterventionBehavioural
The Antibiotic Stewardship Intervention will consist of education, motivating opinion leaders, adapting a pragmatic disease severity classification and prospective audit and feedback.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients will be treated as standard of care. |
| Antibiotic Stewardship Intervention | Experimental | Patients will be treated as standard of care. The Antibiotic Stewardship Intervention will be targeted at the physicians treating the community-acquired pneumonia patients. The purpose of the intervention is to increase prescription concordance with the national guideline for community-acquired pneumonia. Receives: Behavioral: Antibiotic Stewardship Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Broad-spectrum antibiotic use
Antibiotic use will be registered during hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
90-day mortality
All-cause mortality on day 90 from admission will be assessed from the municipal personal records database
Measured: 90-days after hospital admission
Secondary outcomes (8)
30-day mortality
All-cause mortality on day 30 from admission will be assessed from the municipal personal records database
Measured: 30-days after hospital admission
Length of hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Clostridium difficile infections
Clostridium difficile polymerase chain reaction (PCR) outcomes will be registered during hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Length of intravenous antibiotic treatment
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Complications
Complications of pneumonia during admission are registered from the clinical record
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Hospital readmissions
Hospital readmissions will be registered 30 days after hospital admission
Measured: Hospital readmissions within 30 days of hospital admission will be registered
Antibiotic switches
Switches from intravenous to oral (and vice versa) and switches from broad-spectrum to narrow-spectrum (and vice versa) will be registered
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Intensive Care admissions
Intensive Care admissions will be registered during hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study start1 Nov 2015
- Primary completion1 Nov 2017
- Study completion12 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 4,084 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MJM Bonten, UMC Utrecht
- Investigators
- Marc J.M. Bonten, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604628
- Sponsor's protocol ID
- 1
- Acronym
- CAP-PACT
- Status last verified
- Feb 2019
- First submitted
- 10 Nov 2015
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Schweitzer VA, van Heijl I, Boersma WG, Rozemeijer W, Verduin K, Grootenboers MJ, Sankatsing SUC, van der Bij AK, de Bruijn W, Ammerlaan HSM, Overdevest I, Roorda-van der Vegt JMM, Engel-Dettmers EM, Ayuketah-Ekokobe FE, Haeseker MB, Dorigo-Zetsma JW, van der Linden PD, Boel CHE, Oosterheert JJ, van Werkhoven CH, Bonten MJM; CAP-PACT Study Group. Narrow-spectrum antibiotics for community-acquired pneumonia in Dutch adults (CAP-PACT): a cross-sectional, stepped-wedge, cluster-randomised, non-inferiority, antimicrobial stewardship intervention trial. Lancet Infect Dis. 2022 Feb;22(2):274-283. doi: 10.1016/S1473-3099(21)00255-3. Epub 2021 Oct 7.
PubMed 34627499
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-acquired Pneumonia: Increasing Protocol Adherence by Antibiotic Stewardship in a Stepped Wedge Cluster- Randomized Trial
- ClinicalTrials.gov ID
- NCT02604628
- Acronym / sponsor ID
- CAP-PACT / 1
- Conditions
- Community-acquired Pneumonia
- Keywords
- Pneumonia, Antibiotic Stewardship, Stepped wedge, Antibiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,084 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 13 Nov 2015 (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 determine the effect of a multifaceted antibiotic stewardship intervention on protocol adherence of moderate-severe community-acquired pneumonia.
Detailed description
The purpose of the study is to show a decrease in broad-spectrum antibiotics with a non-inferiority in 90-day mortality. Hospitals with a pre-intervention protocol adherence of >70% are excluded from the primary analysis. Primary analysis will be done with a mixed effects model with a random effects for clusters and time. Crude outcomes and outcomes adjusted for potential confounders will be reported. Primary analysis will be tested one-sided for a decrease in mortality. Secondary analysis to test two-sided for mortality will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients will be treated as standard of care. |
| Antibiotic Stewardship Intervention | Experimental | Behavioral: Antibiotic Stewardship InterventionPatients will be treated as standard of care. The Antibiotic Stewardship Intervention will be targeted at the physicians treating the community-acquired pneumonia patients. The purpose of the intervention is to increase prescription concordance with the national guideline for community-acquired pneumonia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with CAP who get admitted to a non-ICU department are eligible for inclusion.
Key exclusion criteria (10 listed)
- Patients aged below 18 years
- Residence in a nursing home or long-term care facility in the last 14 days
- Patients hospitalized in an acute care hospital for two or more days in the last 14 days
- Patients with a history of Cystic Fibrosis
- Patients with immunodeficiency, defined as having one or more of the following criteria:
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 |
|---|---|---|
| Antibiotic Stewardship InterventionThe Antibiotic Stewardship Intervention will consist of education, motivating opinion leaders, adapting a pragmatic disease severity classification and prospective audit and feedback. | Behavioural | Antibiotic Stewardship Intervention |
Primary outcome
Broad-spectrum antibiotic use
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Antibiotic use will be registered during hospital stay
90-day mortality
Time frame: 90-days after hospital admission
All-cause mortality on day 90 from admission will be assessed from the municipal personal records database
8 secondary outcomes
30-day mortality
Time frame: 30-days after hospital admission
Length of hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Clostridium difficile infections
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Length of intravenous antibiotic treatment
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Complications
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Hospital readmissions
Time frame: Hospital readmissions within 30 days of hospital admission will be registered
Antibiotic switches
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Intensive Care admissions
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
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 22 Feb 2019.
- Derived from this study: PubMed 34627499Schweitzer VA, van Heijl I, Boersma WG, Rozemeijer W, Verduin K, Grootenboers MJ, Sankatsing SUC, van der Bij AK, de Bruijn W, Ammerlaan HSM, Overdevest I, Roorda-van der Vegt JMM, Engel-Dettmers EM, Ayuketah-Ekokobe FE, Haeseker MB, Dorigo-Zetsma JW, van der Linden PD, Boel CHE, Oosterheert JJ, van Werkhoven CH, Bonten MJM; CAP-PACT Study Group. Narrow-spectrum antibiotics for community-acquired pneumonia in Dutch adults (CAP-PACT): a cross-sectional, stepped-wedge, cluster-randomised, non-inferiority, antimicrobial stewardship intervention trial. Lancet Infect Dis. 2022 Feb;22(2):274-283. doi: 10.1016/S1473-3099(21)00255-3. Epub 2021 Oct 7.
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Community-Acquired Pneumonia (CAP)
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.
Marc J.M. Bonten, MD, PhD principal investigator
UMC Utrecht
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic Stewardship Intervention in people with Community-acquired Pneumonia, run by UMC Utrecht at 12 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 1 inclusion and 10 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 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Broad-spectrum antibiotic use (time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week). The study lists 2 primary outcomes in all. 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 NCT02604628, which also lists 1 linked publication.
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 22 Feb 2019.