Community-acquired PneumoniaPhase 4CAP5NCT04089787
Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia
A Phase 4 study testing Intervention in people with Community-acquired Pneumonia, run by Thomas Benfield at 7 sites in Denmark.
Trial summary
CAP5 is an investigator-initiated multicentre non-inferiority randomized controlled trial which aims to assess the efficacy and safety of shortened antibiotic treatment duration of community-acquired pneumonia (CAP) in hospitalized adult patients based on clinical stability criteria. 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?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 7 sitesDenmark
- Study dates
- 18 Sep 2019to 22 Jan 2025
- Phase
- Phase 4
- 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
- Hospitalized with community-acquired pneumonia; defined as new pulmonary infiltrate on chest X-ray and/or CT scan and at least one symptom compatible with pneumonia (cough, fever, dyspnoea and/or chest pain)
- Initiation of antibiotics within 12 hours of the time of the chest X-ray with an infiltrate
- Age ≥ 18 years
- Afebrile (temperature ≤ 37.8 °C) for 48 hours at randomization
- Clinically stable at randomization (systolic blood pressure ≥ 90 mm Hg, heart rate ≤ 100/min., respiratory rate ≤ 24/min., peripheral oxygen saturation ≥ 90%)
Who cannot join
- Immunosuppression (HIV-positive, neutropenia, corticosteroid treatment (≥10 mg/day of prednisone or the equivalent for >30 days), chemotherapy, immunosuppressive agents, immunosuppressed after solid organ transplantation, asplenia)
- Hospitalization during the previous 14 days
- Antibiotic treatment (>2 days) within the past 30 days, directed at lower respiratory tract pathogens
- Uncommon cause requiring longer duration of antimicrobial therapy (Pseudomonas aeruginosa, Staphylococcus aureus, Mycobacterium spp., fungi)
- Extrapulmonary infection (e.g. endocarditis, meningitis, or abscess)
- Pleural empyema or lung abscess
Show all 9Show fewer
- Pleural effusion requiring drainage tube
- Intensive care unit (ICU) admittance
- Pregnancy and breastfeeding
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Aalborg University Hospital
Aalborg, 9000
Bispebjerg Hospital
Copenhagen, 2400
Gentofte Hospital
Gentofte Municipality, 2900
Herlev Hospital
Herlev, 2730
Nordsjællands Hospital
Hillerød, 3400
Hvidovre Hospital
Hvidovre, 2650
Odense University Hospital
Odense, 5000
About this study
Official title: Shortened Antibiotic Treatment in Community-Acquired Pneumonia: A Nationwide Danish Randomized Controlled Trial
CAP5 is an investigator-initiated multicentre non-inferiority randomized controlled trial which aims to assess the efficacy and safety of shortened antibiotic treatment duration of community-acquired pneumonia (CAP) in hospitalized adult patients based on clinical stability criteria.
Three to five days after initiation of antimicrobial therapy for CAP, participants are randomized 1:1 to parallel treatment arms: 5 days (intervention) or minimum 7 days (control) of antibiotic treatment. The intervention group discontinues antibiotics at day 5 if clinically stable and afebrile for at least 48 hours. The control group receives antibiotics for a duration of 7 days or longer at the discretion of the treating physician.
The primary outcome is 90-day survival which will be tested with a non-inferiority margin of 6%.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Intervention, Control
- Keywords
- Community-acquired pneumonia, Treatment duration, Pneumonia, Lung Diseases, Respiratory Tract Diseases, Respiratory Tract Infections, Bacterial Infections, Pneumonia, Bacterial, Anti-Infective Agents, Anti-Bacterial Agents
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia, Lung Diseases, Respiratory Tract Diseases, Respiratory Tract Infections, Bacterial Infections, Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Shortened antibiotic treatment of 5 days
ControlOther
Antibiotic treatment of 7 days or longer at the discretion of the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Shortened antibiotic treatment of 5 days Receives: Other: Intervention |
| Control group | Active comparator | Antibiotic treatment of 7 days or longer at the discretion of the treating physician Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day survival
Measured: within 90 days
Secondary outcomes (9)
Duration of antibiotic treatment
Days that the participant receives antibiotic treatment for pneumonia, adding intravenous and oral therapy
Measured: within 90 days
Length of hospital stay
Days from the date of hospital admission for pneumonia to the date of discharge
Measured: within 90 days
Antibiotic adverse events
Number of participants with adverse events with possible relation to the antibiotic treatment of pneumonia
Measured: within 90 days
Serious adverse events
Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines
Measured: within 90 days
Major complications
Number of participants with major complications, including pleural effusion, pleural empyema, lung abscess, respiratory failure, severe sepsis, renal failure, use of non-invasive or invasive ventilation, need for vasopressors, and intensive care unit (ICU) admission
Measured: within 90 days
Use of antimicrobials after discharge
Days of antibiotic treatment for any reason after hospital discharge
Measured: within 90 days
Post-discharge follow-up visits
Number of participants with medical visits after hospital discharge, including visits at the outpatient clinic and at the general practitioner
Measured: within 90 days
Readmissions
Number of participants with readmissions for reasons related to or unrelated to pneumonia
Measured: days 30 and 90
Mortality
Number of deaths by any cause
Measured: in-hospital, days 30 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start18 Sep 2019
- Primary completion22 Jan 2025
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Benfield
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Benfield, Hvidovre University Hospital
- Investigators
- Simone Bastrup Israelsen, MD, Principal investigator, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089787
- Sponsor's protocol ID
- H-19014479
- Other IDs
- 2019-000404-15, 2019
- Acronym
- CAP5
- Status last verified
- Apr 2025
- First submitted
- 11 Sep 2019
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Trial data will be made available in anonymous form at public clinical trial databases when the trial has ended. Anonymized patient-level data and other detailed information will be provided by reasonable request to the principal investigator.
Publications
Welte T, Torres A, Nathwani D. Clinical and economic burden of community-acquired pneumonia among adults in Europe. Thorax. 2012 Jan;67(1):71-9. doi: 10.1136/thx.2009.129502. Epub 2010 Aug 20.
PubMed 20729232Ramirez JA, Wiemken TL, Peyrani P, Arnold FW, Kelley R, Mattingly WA, Nakamatsu R, Pena S, Guinn BE, Furmanek SP, Persaud AK, Raghuram A, Fernandez F, Beavin L, Bosson R, Fernandez-Botran R, Cavallazzi R, Bordon J, Valdivieso C, Schulte J, Carrico RM; University of Louisville Pneumonia Study Group. Adults Hospitalized With Pneumonia in the United States: Incidence, Epidemiology, and Mortality. Clin Infect Dis. 2017 Nov 13;65(11):1806-1812. doi: 10.1093/cid/cix647.
PubMed 29020164Egelund GB, Jensen AV, Andersen SB, Petersen PT, Lindhardt BO, von Plessen C, Rohde G, Ravn P. Penicillin treatment for patients with Community-Acquired Pneumonia in Denmark: a retrospective cohort study. BMC Pulm Med. 2017 Apr 20;17(1):66. doi: 10.1186/s12890-017-0404-8.
PubMed 28427381Uranga A, Espana PP, Bilbao A, Quintana JM, Arriaga I, Intxausti M, Lobo JL, Tomas L, Camino J, Nunez J, Capelastegui A. Duration of Antibiotic Treatment in Community-Acquired Pneumonia: A Multicenter Randomized Clinical Trial. JAMA Intern Med. 2016 Sep 1;176(9):1257-65. doi: 10.1001/jamainternmed.2016.3633.
PubMed 27455166Aliberti S, Ramirez J, Giuliani F, Wiemken T, Sotgiu G, Tedeschi S, Carugati M, Valenti V, Marchioni M, Camera M, Piro R, Del Forno M, Milani G, Faverio P, Richeldi L, Deotto M, Villani M, Voza A, Tobaldini E, Bernardi M, Bellone A, Bassetti M, Blasi F. Individualizing duration of antibiotic therapy in community-acquired pneumonia. Pulm Pharmacol Ther. 2017 Aug;45:191-201. doi: 10.1016/j.pupt.2017.06.008. Epub 2017 Jun 27.
PubMed 28666965Dunbar LM, Wunderink RG, Habib MP, Smith LG, Tennenberg AM, Khashab MM, Wiesinger BA, Xiang JX, Zadeikis N, Kahn JB. High-dose, short-course levofloxacin for community-acquired pneumonia: a new treatment paradigm. Clin Infect Dis. 2003 Sep 15;37(6):752-60. doi: 10.1086/377539. Epub 2003 Aug 28.
PubMed 12955634el Moussaoui R, de Borgie CA, van den Broek P, Hustinx WN, Bresser P, van den Berk GE, Poley JW, van den Berg B, Krouwels FH, Bonten MJ, Weenink C, Bossuyt PM, Speelman P, Opmeer BC, Prins JM. Effectiveness of discontinuing antibiotic treatment after three days versus eight days in mild to moderate-severe community acquired pneumonia: randomised, double blind study. BMJ. 2006 Jun 10;332(7554):1355. doi: 10.1136/bmj.332.7554.1355.
PubMed 16763247Torres A, Muir JF, Corris P, Kubin R, Duprat-Lomon I, Sagnier PP, Hoffken G. Effectiveness of oral moxifloxacin in standard first-line therapy in community-acquired pneumonia. Eur Respir J. 2003 Jan;21(1):135-43. doi: 10.1183/09031936.03.00045202.
PubMed 12570122File TM Jr, Mandell LA, Tillotson G, Kostov K, Georgiev O. Gemifloxacin once daily for 5 days versus 7 days for the treatment of community-acquired pneumonia: a randomized, multicentre, double-blind study. J Antimicrob Chemother. 2007 Jul;60(1):112-20. doi: 10.1093/jac/dkm119. Epub 2007 May 30.
PubMed 17537866Tamma PD, Avdic E, Li DX, Dzintars K, Cosgrove SE. Association of Adverse Events With Antibiotic Use in Hospitalized Patients. JAMA Intern Med. 2017 Sep 1;177(9):1308-1315. doi: 10.1001/jamainternmed.2017.1938.
PubMed 28604925Huttner A, Harbarth S, Carlet J, Cosgrove S, Goossens H, Holmes A, Jarlier V, Voss A, Pittet D. Antimicrobial resistance: a global view from the 2013 World Healthcare-Associated Infections Forum. Antimicrob Resist Infect Control. 2013 Nov 18;2:31. doi: 10.1186/2047-2994-2-31. eCollection 2013.
PubMed 24237856Pollack LA, Srinivasan A. Core elements of hospital antibiotic stewardship programs from the Centers for Disease Control and Prevention. Clin Infect Dis. 2014 Oct 15;59 Suppl 3(Suppl 3):S97-100. doi: 10.1093/cid/ciu542.
PubMed 25261548Madaras-Kelly KJ, Burk M, Caplinger C, Bohan JG, Neuhauser MM, Goetz MB, Zhang R, Cunningham FE; Pneumonia Duration of Therapy Medication Utilization Evaluation Group. Total duration of antimicrobial therapy in veterans hospitalized with uncomplicated pneumonia: Results of a national medication utilization evaluation. J Hosp Med. 2016 Dec;11(12):832-839. doi: 10.1002/jhm.2648. Epub 2016 Aug 16.
PubMed 27527659Aliberti S, Blasi F, Zanaboni AM, Peyrani P, Tarsia P, Gaito S, Ramirez JA. Duration of antibiotic therapy in hospitalised patients with community-acquired pneumonia. Eur Respir J. 2010 Jul;36(1):128-34. doi: 10.1183/09031936.00130909. Epub 2009 Nov 19.
PubMed 19926738Li JZ, Winston LG, Moore DH, Bent S. Efficacy of short-course antibiotic regimens for community-acquired pneumonia: a meta-analysis. Am J Med. 2007 Sep;120(9):783-90. doi: 10.1016/j.amjmed.2007.04.023.
PubMed 17765048
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shortened Antibiotic Treatment in Community-Acquired Pneumonia: A Nationwide Danish Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04089787
- Acronym / sponsor ID
- CAP5 / H-19014479
- Conditions
- Community-acquired Pneumonia
- Keywords
- Community-acquired pneumonia, Treatment duration, Pneumonia, Lung Diseases, Respiratory Tract Diseases, Respiratory Tract Infections, Bacterial Infections, Pneumonia, Bacterial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- Thomas BenfieldUniversity, hospital or other
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 13 Sep 2019 (actual)
- 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.
CAP5 is an investigator-initiated multicentre non-inferiority randomized controlled trial which aims to assess the efficacy and safety of shortened antibiotic treatment duration of community-acquired pneumonia (CAP) in hospitalized adult patients based on clinical stability criteria.
Three to five days after initiation of antimicrobial therapy for CAP, participants are randomized 1:1 to parallel treatment arms: 5 days (intervention) or minimum 7 days (control) of antibiotic treatment. The intervention group discontinues antibiotics at day 5 if clinically stable and afebrile for at least 48 hours. The control group receives antibiotics for a duration of 7 days or longer at the discretion of the treating physician.
The primary outcome is 90-day survival which will be tested with a non-inferiority margin of 6%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: InterventionShortened antibiotic treatment of 5 days |
| Control group | Active comparator | Other: ControlAntibiotic treatment of 7 days or longer at the discretion of the treating physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hospitalized with community-acquired pneumonia; defined as new pulmonary infiltrate on chest X-ray and/or CT scan and at least one symptom compatible with pneumonia (cough, fever, dyspnoea and/or chest pain)
- Initiation of antibiotics within 12 hours of the time of the chest X-ray with an infiltrate
- Age ≥ 18 years
- Afebrile (temperature ≤ 37.8 °C) for 48 hours at randomization
- Clinically stable at randomization (systolic blood pressure ≥ 90 mm Hg, heart rate ≤ 100/min., respiratory rate ≤ 24/min., peripheral oxygen saturation ≥ 90%)
Key exclusion criteria (9 listed)
- Immunosuppression (HIV-positive, neutropenia, corticosteroid treatment (≥10 mg/day of prednisone or the equivalent for >30 days), chemotherapy, immunosuppressive agents, immunosuppressed after solid organ transplantation, asplenia)
- Hospitalization during the previous 14 days
- Antibiotic treatment (>2 days) within the past 30 days, directed at lower respiratory tract pathogens
- Uncommon cause requiring longer duration of antimicrobial therapy (Pseudomonas aeruginosa, Staphylococcus aureus, Mycobacterium spp., fungi)
- Extrapulmonary infection (e.g. endocarditis, meningitis, or abscess)
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 |
|---|---|---|
| InterventionShortened antibiotic treatment of 5 days | Other | Intervention group |
| ControlAntibiotic treatment of 7 days or longer at the discretion of the treating physician | Other | Control group |
Primary outcome
90-day survival
Time frame: within 90 days
9 secondary outcomes
Duration of antibiotic treatment
Time frame: within 90 days
Length of hospital stay
Time frame: within 90 days
Antibiotic adverse events
Time frame: within 90 days
Serious adverse events
Time frame: within 90 days
Major complications
Time frame: within 90 days
Use of antimicrobials after discharge
Time frame: within 90 days
Post-discharge follow-up visits
Time frame: within 90 days
Readmissions
Time frame: days 30 and 90
Mortality
Time frame: in-hospital, days 30 and 90
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 3 Apr 2025.
- Background: PubMed 20729232Welte T, Torres A, Nathwani D. Clinical and economic burden of community-acquired pneumonia among adults in Europe. Thorax. 2012 Jan;67(1):71-9. doi: 10.1136/thx.2009.129502. Epub 2010 Aug 20.
- Background: PubMed 29020164Ramirez JA, Wiemken TL, Peyrani P, Arnold FW, Kelley R, Mattingly WA, Nakamatsu R, Pena S, Guinn BE, Furmanek SP, Persaud AK, Raghuram A, Fernandez F, Beavin L, Bosson R, Fernandez-Botran R, Cavallazzi R, Bordon J, Valdivieso C, Schulte J, Carrico RM; University of Louisville Pneumonia Study Group. Adults Hospitalized With Pneumonia in the United States: Incidence, Epidemiology, and Mortality. Clin Infect Dis. 2017 Nov 13;65(11):1806-1812. doi: 10.1093/cid/cix647.
- Background: PubMed 28427381Egelund GB, Jensen AV, Andersen SB, Petersen PT, Lindhardt BO, von Plessen C, Rohde G, Ravn P. Penicillin treatment for patients with Community-Acquired Pneumonia in Denmark: a retrospective cohort study. BMC Pulm Med. 2017 Apr 20;17(1):66. doi: 10.1186/s12890-017-0404-8.
- Background: PubMed 27455166Uranga A, Espana PP, Bilbao A, Quintana JM, Arriaga I, Intxausti M, Lobo JL, Tomas L, Camino J, Nunez J, Capelastegui A. Duration of Antibiotic Treatment in Community-Acquired Pneumonia: A Multicenter Randomized Clinical Trial. JAMA Intern Med. 2016 Sep 1;176(9):1257-65. doi: 10.1001/jamainternmed.2016.3633.
- Background: PubMed 28666965Aliberti S, Ramirez J, Giuliani F, Wiemken T, Sotgiu G, Tedeschi S, Carugati M, Valenti V, Marchioni M, Camera M, Piro R, Del Forno M, Milani G, Faverio P, Richeldi L, Deotto M, Villani M, Voza A, Tobaldini E, Bernardi M, Bellone A, Bassetti M, Blasi F. Individualizing duration of antibiotic therapy in community-acquired pneumonia. Pulm Pharmacol Ther. 2017 Aug;45:191-201. doi: 10.1016/j.pupt.2017.06.008. Epub 2017 Jun 27.
- Background: PubMed 12955634Dunbar LM, Wunderink RG, Habib MP, Smith LG, Tennenberg AM, Khashab MM, Wiesinger BA, Xiang JX, Zadeikis N, Kahn JB. High-dose, short-course levofloxacin for community-acquired pneumonia: a new treatment paradigm. Clin Infect Dis. 2003 Sep 15;37(6):752-60. doi: 10.1086/377539. Epub 2003 Aug 28.
- Background: PubMed 16763247el Moussaoui R, de Borgie CA, van den Broek P, Hustinx WN, Bresser P, van den Berk GE, Poley JW, van den Berg B, Krouwels FH, Bonten MJ, Weenink C, Bossuyt PM, Speelman P, Opmeer BC, Prins JM. Effectiveness of discontinuing antibiotic treatment after three days versus eight days in mild to moderate-severe community acquired pneumonia: randomised, double blind study. BMJ. 2006 Jun 10;332(7554):1355. doi: 10.1136/bmj.332.7554.1355.
- Background: PubMed 12570122Torres A, Muir JF, Corris P, Kubin R, Duprat-Lomon I, Sagnier PP, Hoffken G. Effectiveness of oral moxifloxacin in standard first-line therapy in community-acquired pneumonia. Eur Respir J. 2003 Jan;21(1):135-43. doi: 10.1183/09031936.03.00045202.
- Background: PubMed 17537866File TM Jr, Mandell LA, Tillotson G, Kostov K, Georgiev O. Gemifloxacin once daily for 5 days versus 7 days for the treatment of community-acquired pneumonia: a randomized, multicentre, double-blind study. J Antimicrob Chemother. 2007 Jul;60(1):112-20. doi: 10.1093/jac/dkm119. Epub 2007 May 30.
- Background: PubMed 28604925Tamma PD, Avdic E, Li DX, Dzintars K, Cosgrove SE. Association of Adverse Events With Antibiotic Use in Hospitalized Patients. JAMA Intern Med. 2017 Sep 1;177(9):1308-1315. doi: 10.1001/jamainternmed.2017.1938.
- Background: PubMed 24237856Huttner A, Harbarth S, Carlet J, Cosgrove S, Goossens H, Holmes A, Jarlier V, Voss A, Pittet D. Antimicrobial resistance: a global view from the 2013 World Healthcare-Associated Infections Forum. Antimicrob Resist Infect Control. 2013 Nov 18;2:31. doi: 10.1186/2047-2994-2-31. eCollection 2013.
- Background: PubMed 25261548Pollack LA, Srinivasan A. Core elements of hospital antibiotic stewardship programs from the Centers for Disease Control and Prevention. Clin Infect Dis. 2014 Oct 15;59 Suppl 3(Suppl 3):S97-100. doi: 10.1093/cid/ciu542.
- Individual participant dataSharing planned: No. Trial data will be made available in anonymous form at public clinical trial databases when the trial has ended. Anonymized patient-level data and other detailed information will be provided by reasonable request to the principal investigator.
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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.
Simone Bastrup Israelsen, MD principal investigator
Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intervention in people with Community-acquired Pneumonia, run by Thomas Benfield at 7 sites in Denmark.
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 5 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 3 Apr 2025. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
90-day survival (time frame: within 90 days). 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 NCT04089787, which also lists 25 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 3 Apr 2025.