Community-acquired PneumoniaCAP-STARTNCT01660204
Community-Acquired Pneumonia - Study on the Initial Treatment With Antibiotics of Lower Respiratory Tract Infections
A study testing Preferred empirical treatment in people with Community-acquired Pneumonia, run by UMC Utrecht at 7 sites in Netherlands.
Trial summary
The purpose of this study is to compare the cost(effectiveness) of three existing antibiotic strategies for patients with community-acquired pneumonia admitted to the hospital, but not the ICU. 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?
- Preferred empirical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,283 participants
- Where
- 7 sitesNetherlands
- Study dates
- Feb 2011to Jan 2014
- 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
- All patients admitted to one of the participating hospitals needing treatment for CAP, not being admitted to the ICU are eligible for study inclusion.
- Admission is defined as hospital stay for more than 24 hours.
Who cannot join
- Patients who are readmitted with CAP within 2 weeks after a previous episode are not eligible.
- Patients with cystic fibrosis are not eligible.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Netherlands7 sites
Medical Center Alkmaar
Alkmaar
AMC Amsterdam
Amsterdam
Amphia Hospital Breda
Breda
Kennemer Gasthuis
Haarlem
Spaarne Hospital
Hoofddorp
Diakonessenhuis Utrecht
Utrecht
UMC Utrecht
Utrecht
About this study
Official title: Antibiotic Treatment of Community-acquired Pneumonia: a Prospective Comparison of Dutch Guideline Advices.
The purpose of this study is to compare the cost(effectiveness) of three existing antibiotic strategies for patients with community-acquired pneumonia admitted to the hospital, but not the ICU.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Preferred empirical treatment
- Keywords
- pneumonia, anti-bacterial agents, (cost)efficacy
- 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.
Preferred empirical treatmentOther
The investigators are using a cluster-randomized cross-over design for preferred empirical treatment. One of the 3 treatment arms is used as preferred empirical therapy during a period of 4 consecutive months, after which preferred treatment will rotate to 1 of the other 2 regimens. The order of change is randomised per hospital, thereby controlling for inter-hospital variables and minimizing seasonal influences.
| Study group | Role | What they receive |
|---|---|---|
| Betalactam monotherapy | Active comparator | Preferred empirical treatment for patients in this arm is Beta-lactam monotherapy e.g. co-amoxiclav or ceftriaxone Receives: Other: Preferred empirical treatment |
| Betalactam combination with macrolide | Active comparator | Preferred empirical treatment for patients in this arm is beta-lactam combination therapy with a macrolide e.g. ceftriaxone and erythromycin Receives: Other: Preferred empirical treatment |
| Quinolone monotherapy | Active comparator | Preferred empirical treatment for patients in this arm is quinolone monotherapy e.g. moxifloxacin or levofloxacin Receives: Other: Preferred empirical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 90 Mortality
We will assess all-cause mortality on day 90 from admission from the municipal personal records database
Measured: 90 days from admission
Secondary outcomes (5)
Length of intravenous antibiotic treatment
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Length of hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Tolerability
Side-effects and complications from antibiotic therapy are registered from clinical record
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 clinical record.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Health care costs and non-health care costs
Health care costs and non-health care costs are assessed using a short questionnaire 28 days from admission
Measured: 28 days from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startFeb 2011
- Primary completionNov 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 2,283 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, MJM Bonten, UMC Utrecht
- Investigators
- Marc J. Bonten, MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660204
- Sponsor's protocol ID
- 10-148
- Other IDs
- 80-82310-97-12044
- Acronym
- CAP-START
- Status last verified
- Apr 2014
- First submitted
- 2 May 2012
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Postma DF, Spitoni C, van Werkhoven CH, van Elden LJR, Oosterheert JJ, Bonten MJM. Cardiac events after macrolides or fluoroquinolones in patients hospitalized for community-acquired pneumonia: post-hoc analysis of a cluster-randomized trial. BMC Infect Dis. 2019 Jan 7;19(1):17. doi: 10.1186/s12879-018-3630-7.
PubMed 30612559van Werkhoven CH, Postma DF, Mangen MJ, Oosterheert JJ, Bonten MJ; CAP-START study group. Cost-effectiveness of antibiotic treatment strategies for community-acquired pneumonia: results from a cluster randomized cross-over trial. BMC Infect Dis. 2017 Jan 10;17(1):52. doi: 10.1186/s12879-016-2179-6.
PubMed 28068956Postma DF, van Werkhoven CH, van Elden LJ, Thijsen SF, Hoepelman AI, Kluytmans JA, Boersma WG, Compaijen CJ, van der Wall E, Prins JM, Oosterheert JJ, Bonten MJ; CAP-START Study Group. Antibiotic treatment strategies for community-acquired pneumonia in adults. N Engl J Med. 2015 Apr 2;372(14):1312-23. doi: 10.1056/NEJMoa1406330.
PubMed 25830421van Werkhoven CH, Postma DF, Oosterheert JJ, Bonten MJ. Antibiotic treatment of moderate-severe community-acquired pneumonia: design and rationale of a multicentre cluster-randomised cross-over trial. Neth J Med. 2014 Apr;72(3):170-8.
PubMed 24846935
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Treatment of Community-acquired Pneumonia: a Prospective Comparison of Dutch Guideline Advices.
- ClinicalTrials.gov ID
- NCT01660204
- Acronym / sponsor ID
- CAP-START / 10-148
- Conditions
- Community-acquired Pneumonia
- Keywords
- pneumonia, anti-bacterial agents, (cost)efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,283 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Feb 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 8 Aug 2012 (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 compare the cost(effectiveness) of three existing antibiotic strategies for patients with community-acquired pneumonia admitted to the hospital, but not the ICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Betalactam monotherapy | Active comparator | Other: Preferred empirical treatmentPreferred empirical treatment for patients in this arm is Beta-lactam monotherapy e.g. co-amoxiclav or ceftriaxone |
| Betalactam combination with macrolide | Active comparator | Other: Preferred empirical treatmentPreferred empirical treatment for patients in this arm is beta-lactam combination therapy with a macrolide e.g. ceftriaxone and erythromycin |
| Quinolone monotherapy | Active comparator | Other: Preferred empirical treatmentPreferred empirical treatment for patients in this arm is quinolone monotherapy e.g. moxifloxacin or levofloxacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients admitted to one of the participating hospitals needing treatment for CAP, not being admitted to the ICU are eligible for study inclusion.
- Admission is defined as hospital stay for more than 24 hours.
Key exclusion criteria (2 listed)
- Patients who are readmitted with CAP within 2 weeks after a previous episode are not eligible.
- Patients with cystic fibrosis are not eligible.
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 |
|---|---|---|
| Preferred empirical treatmentThe investigators are using a cluster-randomized cross-over design for preferred empirical treatment. One of the 3 treatment arms is used as preferred empirical therapy during a period of 4 consecutive months, after which preferred treatment will rotate to 1 of the other 2 regimens. The order of change is randomised per hospital, thereby controlling for inter-hospital variables and minimizing seasonal influences. | Other | Betalactam combination with macrolide, Betalactam monotherapy, Quinolone monotherapy |
Primary outcome
Day 90 Mortality
Time frame: 90 days from admission
We will assess all-cause mortality on day 90 from admission from the municipal personal records database
5 secondary outcomes
Length of intravenous antibiotic treatment
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Length of hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Tolerability
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
Health care costs and non-health care costs
Time frame: 28 days from admission
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 23 Apr 2014.
- Derived from this study: PubMed 30612559Postma DF, Spitoni C, van Werkhoven CH, van Elden LJR, Oosterheert JJ, Bonten MJM. Cardiac events after macrolides or fluoroquinolones in patients hospitalized for community-acquired pneumonia: post-hoc analysis of a cluster-randomized trial. BMC Infect Dis. 2019 Jan 7;19(1):17. doi: 10.1186/s12879-018-3630-7.
- Derived from this study: PubMed 28068956van Werkhoven CH, Postma DF, Mangen MJ, Oosterheert JJ, Bonten MJ; CAP-START study group. Cost-effectiveness of antibiotic treatment strategies for community-acquired pneumonia: results from a cluster randomized cross-over trial. BMC Infect Dis. 2017 Jan 10;17(1):52. doi: 10.1186/s12879-016-2179-6.
- Derived from this study: PubMed 25830421Postma DF, van Werkhoven CH, van Elden LJ, Thijsen SF, Hoepelman AI, Kluytmans JA, Boersma WG, Compaijen CJ, van der Wall E, Prins JM, Oosterheert JJ, Bonten MJ; CAP-START Study Group. Antibiotic treatment strategies for community-acquired pneumonia in adults. N Engl J Med. 2015 Apr 2;372(14):1312-23. doi: 10.1056/NEJMoa1406330.
- Derived from this study: PubMed 24846935van Werkhoven CH, Postma DF, Oosterheert JJ, Bonten MJ. Antibiotic treatment of moderate-severe community-acquired pneumonia: design and rationale of a multicentre cluster-randomised cross-over trial. Neth J Med. 2014 Apr;72(3):170-8.
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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.
Marc J. Bonten, MD PhD principal investigator
UMC Utrecht
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preferred empirical treatment in people with Community-acquired Pneumonia, run by UMC Utrecht at 7 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 2 inclusion and 2 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 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Day 90 Mortality (time frame: 90 days from admission). 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 NCT01660204, which also lists 4 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 23 Apr 2014; AzTrials last refreshed its copy on 6 Nov 2026.