Community-acquired PneumoniaPhase 2/3LANDCAP 2NCT07843017
Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
A Phase 2/3 study testing Inhaled levofloxacin in people with Community-acquired Pneumonia and CAP, run by Copenhagen Respiratory Research at 1 site in Denmark.
Trial summary
This trial aims to determine whether treatment with inhaled levofloxacin (an antibiotic) is equal to systemic antibiotic treatment (usual care) for patients admitted to a hospital with community-acquired pneumonia in regards to treatment-effect and safety parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia, CAP, Community Acquired Pneumonia
- What is being tested?
- Inhaled levofloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Oct 2026to 1 Sep 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Hospital admission within 24 hours.
- Clinical suspicion of community-acquired pneumonia necessitating antibiotic treatment.
- Defined as one or more of the following:
- Chest X-ray, CT or ultrasound findings consistent with bacterial pneumonia*
- Symptoms consistent with bacterial pneumonia (such as dyspnea, tachypnea, cough or purulent sputum)
- C-reactive protein >50 mg/L OR central body temperature >38.0 °C OR blood leukocytes ≥10.0×109/L (1-3 of these fulfilled).
- Age ≥ 18 years.
- Able to give informed consent.
Who cannot join
- Suspected septic shock defined as MAP < 65 mmHg on sequential measurements despite adequate volume resuscitation.
- Oxygen requirement >4L/min to maintain acceptable peripheral oxygen saturation*.
- Significant suspicion of an infection with a focus other than the lungs
- Contraindications for fluoroquinolone treatment, including but not limited to:
- Known allergy to fluoroquinolones or a serious adverse reaction when previously treated with a fluoroquinolone.
- Medical history of myasthenia gravis.
Show all 10Show fewer
- Reduced kidney function (eGFR < 20 mL/min/1.73 m²).
- Suspected aspiration pneumonia, pulmonary abscess, or pleural empyema / complicated parapneumonic effusion.
- Suspicion of clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) > 480ms).
- Pregnancy**.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Herlev and Gentofte University hospital
Gentofte Municipality, Capital Region, 2820
About this study
Official title: Local Antibiotic Delivery for Community Acquired Pneumonia
This trial aims to determine whether treatment with inhaled levofloxacin (an antibiotic) is equal to systemic antibiotic treatment (usual care) for patients admitted to a hospital with community-acquired pneumonia in regards to treatment-effect and safety parameters.
Additionally, this study will assess if treatment with inhaled antibiotics leads to fewer antibiotic side-effects and a more preserved gastro-intestinal microbial environment.
Read more
The main question this study aims to answer is:
Does inhaled levofloxacin 240mg twice daily result in comparable days alive and out of hospital at 14 days compared to standard-of-care (usual care) antibiotic treatment for community-acquired pneumonia in admitted patients?
Secondary questions this study aims to answer are:
- Does treatment with inhaled levofloxacin reduce proportion of patients with antibiotic side-effects?
- Does treatment with inhaled levofloxacin lead to preserved diversity in the gut microbiome?
- Is treatment with inhaled levofloxacin comparable with usual care in regards to patient reported outcomes?
The above list is not the complete list of questions this study aims to answer, but serves as highlights.
Read the detailed description
Community-acquired pneumonia is common and potentially fatal. Standard-of-care treatment mainly consists of systemic antibiotics and treatment supporting recovery (e.g. oxygen-therapy, fluid rescucitation, respiratory physiotherapy, sufficient dietary intake etc.). As with all medicinal treatments, antibiotic treatment is hard on the body and can lead to side-effects as well as organ-failure in extreme cases.
Antibiotic treatment naturally promotes antimicrobial resistance (AMR), which result in less effective antibiotic treatment, and ultimately it could potentially lead to antibiotics being rendered useless in treating infections such as pneumonia.
A strategy to reduce the promotion of antimicrobial restistance (AMR) is better targeting of the disease-inducing microbes and several other strategies exists. Physicians and researchers usually categorize the targeting of disease-promoting microbes as either "local"/"topical" or "systemic". No "local" treatment of community-acquired pneumonia has been demonstrated to this day, but "local" treatment is theoretically possible with inhaled antibiotics. This treatment strategy has been hypothesized in the last decade, but no studies have been conducted regarding community-acquired pneumonia.
This study will include 460 patients and be conducted in two stages: Stage A and Stage B, each stage including 230 patients.
Patients are included voluntarilty and with prior written informed consent.
Patients included in stage A will be treated with systemic antibiotics for 24 hours and will then be randomized to further treatment with either inhaled levofloxacin 240mg twice daily or continue the "usual care"-treatment that they were receiving. The duration of intervention is up to 5 days.
At 230 included patients a planned interrim analysis will be conducted by an appointed data safety monitoring board of certified healthcare professionals to assess the further continuation of the trial. If favorable assessment, the trial will commence to Stage B.
Patients included in Stage B will be randomized at admission to either usual standard-of-care treatment for 5 days OR inhaled levofloxacin 240mg twice daily for 5 days.
The trial is open-label, which means that both patients and healthcare professionals will know which treatment arm the patient is receiving.
- Conditions
- Community-acquired Pneumonia, CAP, Community Acquired Pneumonia, Pneumonia, Microbial Composition
- Being tested
- Inhaled levofloxacin, Standard-of-care / Usual care
- Keywords
- Inhaled antibiotics, Nebulized antibiotics, Aerosolized antibiotics, Levofloxacin, Flourquinolone, CAP, Pneumonia, Community-acquired, Community acquired
- 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.
Inhaled levofloxacinDrug
Inhaled levofloxacin 240mg twice daily
Standard-of-care / Usual careDrug
Standard-of-care / Usual care deemed of antibiotic treatment for community-acquired pneumonia assessed by the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care (Control) | Active comparator | Systemic antibiotic treatment Receives: Drug: Standard-of-care / Usual care |
| Inhaled levofloxacin | Experimental | Not described Receives: Drug: Inhaled levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAOH14
Days alive and out of hospital day 14
Measured: From inclusion to 14 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start8 Oct 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen Respiratory Research
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jens-Ulrik S Jensen, Professor, PhD, Medical Doctor, Study director, Copenhagen Respiratory Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843017
- Sponsor's protocol ID
- 2024-511420-13-00
- Other IDs
- 2024-511420-13-00
- Acronym
- LANDCAP 2
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All reasonable requests will be considered for pseudo-anonymized datasharing in accordance with applicable law of datasharing in the state of Denmark.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Antibiotic Delivery for Community Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT07843017
- Acronym / sponsor ID
- LANDCAP 2 / 2024-511420-13-00
- Conditions
- Community-acquired Pneumonia, CAP, Community Acquired Pneumonia, Pneumonia, Microbial Composition
- Keywords
- Inhaled antibiotics, Nebulized antibiotics, Aerosolized antibiotics, Levofloxacin, Flourquinolone, CAP, Pneumonia, Community-acquired
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Copenhagen Respiratory ResearchResearch network
- Study start
- 8 Oct 2026 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 25 Sep 2026 (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.
This trial aims to determine whether treatment with inhaled levofloxacin (an antibiotic) is equal to systemic antibiotic treatment (usual care) for patients admitted to a hospital with community-acquired pneumonia in regards to treatment-effect and safety parameters.
Additionally, this study will assess if treatment with inhaled antibiotics leads to fewer antibiotic side-effects and a more preserved gastro-intestinal microbial environment.
The main question this study aims to answer is:
Does inhaled levofloxacin 240mg twice daily result in comparable days alive and out of hospital at 14 days compared to standard-of-care (usual care) antibiotic treatment for community-acquired pneumonia in admitted patients?
Secondary questions this study aims to answer are:
- Does treatment with inhaled levofloxacin reduce proportion of patients with antibiotic side-effects?
- Does treatment with inhaled levofloxacin lead to preserved diversity in the gut microbiome?
- Is treatment with inhaled levofloxacin comparable with usual care in regards to patient reported outcomes?
The above list is not the complete list of questions this study aims to answer, but serves as highlights.
Detailed description
Community-acquired pneumonia is common and potentially fatal. Standard-of-care treatment mainly consists of systemic antibiotics and treatment supporting recovery (e.g. oxygen-therapy, fluid rescucitation, respiratory physiotherapy, sufficient dietary intake etc.). As with all medicinal treatments, antibiotic treatment is hard on the body and can lead to side-effects as well as organ-failure in extreme cases.
Antibiotic treatment naturally promotes antimicrobial resistance (AMR), which result in less effective antibiotic treatment, and ultimately it could potentially lead to antibiotics being rendered useless in treating infections such as pneumonia.
A strategy to reduce the promotion of antimicrobial restistance (AMR) is better targeting of the disease-inducing microbes and several other strategies exists. Physicians and researchers usually categorize the targeting of disease-promoting microbes as either "local"/"topical" or "systemic". No "local" treatment of community-acquired pneumonia has been demonstrated to this day, but "local" treatment is theoretically possible with inhaled antibiotics. This treatment strategy has been hypothesized in the last decade, but no studies have been conducted regarding community-acquired pneumonia.
This study will include 460 patients and be conducted in two stages: Stage A and Stage B, each stage including 230 patients.
Patients are included voluntarilty and with prior written informed consent.
Patients included in stage A will be treated with systemic antibiotics for 24 hours and will then be randomized to further treatment with either inhaled levofloxacin 240mg twice daily or continue the "usual care"-treatment that they were receiving. The duration of intervention is up to 5 days.
At 230 included patients a planned interrim analysis will be conducted by an appointed data safety monitoring board of certified healthcare professionals to assess the further continuation of the trial. If favorable assessment, the trial will commence to Stage B.
Patients included in Stage B will be randomized at admission to either usual standard-of-care treatment for 5 days OR inhaled levofloxacin 240mg twice daily for 5 days.
The trial is open-label, which means that both patients and healthcare professionals will know which treatment arm the patient is receiving.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care (Control) | Active comparator | Drug: Standard-of-care / Usual careSystemic antibiotic treatment |
| Inhaled levofloxacin | Experimental | Drug: Inhaled levofloxacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hospital admission within 24 hours.
- Clinical suspicion of community-acquired pneumonia necessitating antibiotic treatment.
- C-reactive protein >50 mg/L OR central body temperature >38.0 °C OR blood leukocytes ≥10.0×109/L (1-3 of these fulfilled).
- Age ≥ 18 years.
- Able to give informed consent.
Key exclusion criteria (10 listed)
- Suspected septic shock defined as MAP < 65 mmHg on sequential measurements despite adequate volume resuscitation.
- Oxygen requirement >4L/min to maintain acceptable peripheral oxygen saturation*.
- Significant suspicion of an infection with a focus other than the lungs
- Contraindications for fluoroquinolone treatment, including but not limited to:
- Reduced kidney function (eGFR < 20 mL/min/1.73 m²).
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 |
|---|---|---|
| Inhaled levofloxacinInhaled levofloxacin 240mg twice daily | Drug | Inhaled levofloxacin |
| Standard-of-care / Usual careStandard-of-care / Usual care deemed of antibiotic treatment for community-acquired pneumonia assessed by the treating physician | Drug | Standard-of-care (Control) |
Primary outcome
DAOH14
Time frame: From inclusion to 14 days after
Days alive and out of hospital day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. All reasonable requests will be considered for pseudo-anonymized datasharing in accordance with applicable law of datasharing in the state of Denmark.
Related trials for Community-acquired Pneumonia
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
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.
Jens-Ulrik S Jensen, Professor, PhD, Medical Doctor study director
Copenhagen Respiratory Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Inhaled levofloxacin in people with Community-acquired Pneumonia and CAP, run by Copenhagen Respiratory Research at 1 site 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 8 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
DAOH14 (time frame: From inclusion to 14 days after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2026.