Community Acquired Pneumonia (CAP)Phase 2/3LANDCAP-1NCT06859450
Local Antibiotic Delivery for Community Acquired Pneumonia
A Phase 2/3 study testing Levofloxacin in people with Community Acquired Pneumonia (CAP), run by Copenhagen Respiratory Research at 1 site in Denmark.
Trial summary
A randomized, double-blinded clinical pilot study to assess whether addition of inhaled levofloxacin 240 mg twice daily for three days leads to improved or worsened physiological status in CAP patients with and without pre-existing lung disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia (CAP)
- What is being tested?
- Levofloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Mar 2025to 17 Mar 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.
- Radiologically new-onset chest infiltrate that is consistent with pneumonia and symptoms or signs also consistent with pneumonia, such as fever, cough, sputum, dyspnoea and/or chest pain
- CURB-65 score 3-5
- C-reactive protein >50 OR central body temperature >38.0 °C (1-2 of these fulfilled)
- Age ≥ 18 years
- Able to give informed consent.
Who cannot join
- Septic shock according to the sepsis III criteria:41 sequential organ failure assessment (SOFA) score ≥2) and suspected infection (according to attending physician) and persisting hypotension requiring vasopressors to maintain MAP≥65 mmHg and serum lactate level>2 mmol/L (18 mg/dL) despite adequate volume resuscitation (30 mL/kg crystalloid within 3 hours).
- Oxygen requirement ≥5 L/min to maintain acceptable saturation assessed by the treating physician.
- Respiratory rate >24/min with relevant oxygen therapy
- Positive COVID or influenza test (PCR or antigen test)
- Known allergy to levofloxacin or other fluoroquinolones or a serious adverse reaction when previously treated with a fluoroquinolone, including tendinitis or tendon-rupture related to fluoroquinolone treatment
- Symptoms of neuropathy (peripheral paraesthesia, hypoesthesia, or hyperalgesia)
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- Known allergy to β-lactam antibiotics or to macrolide antibiotics.
- Medical history of myasthenia gravis
- Reduced kidney function (eGFR < 20)
- Expected transfer to ICU or death within 48 hours or a do not resuscitate ordination at time of recruitment.
- Suspected aspiration pneumonia, pulmonary abscess, or pleural empyema / complicated parapneumonic effusion.
- Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) > 480ms).
- Pregnancy (a negative pregnancy test is required prior to inclusion of all pre-menopausal women)
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 - Pilot Study (LANDCAP1)
A randomized, double-blinded clinical pilot study to assess whether addition of inhaled levofloxacin 240 mg twice daily for three days leads to improved or worsened physiological status in CAP patients with and without pre-existing lung disease.
Read the detailed description
RATIONALE Community-acquired pneumonia (CAP) is a common and potentially severe disease placing a substantial burden on patients and healthcare systems. At the core of the current treatment of CAP is oral or intravenous antibiotics. This poses challenges, both to the individual patient in the form of side-effects due to the antibiotic affecting unintended tissues, as well as to society as current antibiotic prescription patterns may be problematic in the long term due to increasing antimicrobial resistance. Thus, there is a need for alternative treatments that minimize side-effects while reducing the drive of antimicrobial resistance.
The investigators propose inhaled antibiotics as a new treatment modality for CAP. Inhaled administration greatly increases the antibiotic concentration in the lungs, potentially increasing efficacy, while decreasing concentrations in other tissues, potentially reducing side-effects. Especially the gut is important in this regard, as the gut microbiome is much larger than the lung microbiome, therefore the investigators expect that inhaled treatment causes much smaller antibiotic exposure to the bystander bacteria in the gut compared to systemic treatment, reducing antimicrobial resistance selection.
Though results from this study will likely be applicable to other antibiotics, the investigators have specifically chosen to investigate inhaled levofloxacin as it is marketed and has the most favourable side-effect and microbial coverage profile for CAP. Inhaled levofloxacin has been marketed for chronic lung infections since 2015. If the investigators find that inhaled treatment is viable, the investigators hope it will open the path for new inhaled formulations specifically designed for CAP.
To ensure patient safety, the investigators have planned this trial as a small safety trial in which the investigators explore inhaled levofloxacin as an add-on therapy to systemic treatment to collect data on infection control and physiological effects of the drug in a population of CAP patients with or without respiratory comorbidity. These findings will be used in the conduct of a follow-up efficacy trial comparing inhaled treatment to systemic treatment.
The investigators hypothesize that add-on of three days (6 doses over 72 hours) of inhaled levofloxacin to guideline-based treatment of patients with CAP with and without pulmonary comorbidity compared to guideline-based therapy alone is safe and does not cause a worsening of respiratory function defined as decrease in forced end-expiratory volume first second (FEV1).
Further, the investigators hypothesize that such an intervention will lead to comparable disease control defined as an equal number of patients with increasing C-reactive protein, procalcitonin or persistent fever after three days or new onset critical illness.
OBJECTIVES The objective of this study is to determine if addition of inhaled levofloxacin 240 mg twice daily for three days leads to improved or worsened physiological or infectious status in CAP patients with and without pre-existing lung disease.
TRIAL DESIGN A double-blinded randomised controlled trial testing the tolerability and safety of inhaled Levofloxacin in patients admitted to hospital with moderate to severe community-acquired pneumonia.
This study will enrol in total 36 patients:
Of these, all shall have a community-acquired pneumonia (see inclusion criteria below for specific criteria)
Further:
12 subjects with specialist-verified asthma and no other concomitant pulmonary comorbidities.
12 subjects with specialist-verified chronic obstructive pulmonary disease and no other concomitant pulmonary comorbidities.
12 subjects that do not have any pulmonary comorbidities.
INTERVENTION All patients will recieve guideline-based treatment for community-acquired pneumonia. Patients will be randomized 1:1 to recieve blinded add-on treatment with either placebo (saline) or active inhaled levofloxacin 240mg (antibiotic) twice daily for up to 3 days.
All subjects will have the airflow tested before and after their first inhaled treatment and again before discharge or at day 4, whichever comes first.
WORKFLOW Following informed consent, trial participants will fill out a questionnaire about general health status, medicine and comorbidity and the patient's height and weight will be recorded. Furthermore, an electrocardiogram (ECG) will be obtained. For female participants under the age of 55 years who have had a menstruation within 12 months and are not permanently sterile, a pregnancy test will be conducted as part of the screening process. In addition to this, a baseline bedside spirometry will be performed.
The participants will receive a total of 6 inhalations over the course of 72 hours. An investigator or other hospital staff will assist with the medicine administration. Approximately one hour following each inhalation an investigator will perform a clinical assessment of the participant.
SAMPLE SIZE The primary objective of this trial is to evaluate the safety and feasibility of administering inhaled levofloxacin for the treatment of CAP. Additionally the trials aim to gather data and insights to inform the design and implementation of the subsequent main trial (Trial II). To achieve this, the investigators have opted for a conservative patient cohort size. It is recommended to include at least 30 patients in pilot studies, to be able to estimate the standard deviation of population parameters. Therefore, the investigators have chosen to enrol 36 patients stratified by comorbidity in order to ensure robust data collection and analysis.
PUBLICATIONS OF TRIAL RESULTS The results of the trial will be published regardless of whether they are positive, negative, or inconclusive. The trial will be registered and published at clinicaltrials.gov as well as published in an international peer-reviewed scientific journal. Irrespective of the outcome of a clinical trial, within one year from the end of a clinical trial the investigators will submit to the EU database (CTIS) a summary of the results of the clinical trial accompanied by a summary written in a manner that is understandable to laypersons.
If publication in a scientific journal is not possible, the results will be published as an online report.
ETHICAL CONSIDERATIONS Community-acquired pneumonia is a serious and deadly disease which is a great burden on both patients and healthcare systems, and mortality from this condition is still very high. Furthermore, current treatments may not be sustainable in the future due to increasing antimicrobial resistance, which may eventually lead to increasing mortality due to a lack of treatment options.
This study is the first in a line of studies that aims to determine if inhaled antibiotics are a safe, tolerated and an effective way of treatment for a very common and serious disease. Inhaled levofloxacin has been marketed since 2015 and severe adverse events is rare. Overall this study is safe to be conducted.
- Conditions
- Community Acquired Pneumonia (CAP)
- Being tested
- Levofloxacin, Placebo
- Keywords
- Community Acquired Pneumonia, Inhaled levofloxacin, Inhaled antibiotics, feasibility, Chronic obstructive pulmonary disease, asthma, pulmonary healthy, pilot study
- Medical subject headings
- Community-Acquired Pneumonia, Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
Add-on treatment of inhaled Levofloxacin 240mg twice daily or placebo (saline) twice daily for up to 3 days while admitted.
PlaceboDrug
Add-on treatment of inhaled Levofloxacin 240mg twice daily or placebo (saline) twice daily for up to 3 days while admitted.
| Study group | Role | What they receive |
|---|---|---|
| Asthma - Active | Active comparator | Admitted asthma patient recieving active inhalations Receives: Drug: Levofloxacin |
| Asthma - Placebo | Placebo comparator | Admitted asthma patient recieving placebo inhalations Receives: Drug: Placebo |
| Chronic obstructive pulmonary disease - Active | Active comparator | Admitted COPD-patient recieving active inhalations Receives: Drug: Levofloxacin |
| Chronic obstructive pulmonary disease - Placebo | Placebo comparator | Admitted COPD-patient recieving placebo inhalations Receives: Drug: Placebo |
| Pulmonal healthy - Active | Active comparator | Admitted pulmonary healthy patient recieving active inhalations Receives: Drug: Levofloxacin |
| Pulmonal healhty - Placebo | Placebo comparator | Admitted pulmonary healthy patient recieving placebo inhalations Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1 after first inhalation from baseline
Proportion of patients with a drop in FEV1 of 20% or 300mL one hour following the first inhalation.
Measured: Enrollment to second assessment - 1 hour
Secondary outcomes (6)
Change in FEV1 from baseline to day 4 or discharge
Proportion of patients with a drop in FEV1 of 20% or 300mL from baseline to day 4 or discharge, whichever comes first.
Measured: From baseline to day 4 or discharge. Between 24-72 hours.
C-reactive protein (CRP) on day 4 higher than any day from baseline to day 3.
CRP on day 4 higher than on any day from 1 to 3 including baseline.
Measured: Baseline to day 4
Physiological status at day 4
Mean Arterial Pressure ≤ 65 OR respiratory frequency > 25 OR pulse > 100 OR needing supplemental oxygen (1-4 of these fulfilled) on day 4.
Measured: Day 4 assessment
Procalcitonin day 4 compared to any day before including baseline
Procalcitonin on day 4 higher than on any day from 1 to 3 including baseline.
Measured: Baseline to day 4
Temperature at day 4 above 38 degrees celcius
Temperature ≥ 38.0 °C on day 4.
Measured: Day 4 assessment
Patient reported change fra baseline to day 4
Patient reported outcome measurements: Changes in Visual Analogue Scales for dyspnoea, cough and fatigue from baseline to day 4. In all of the used scales the value 1 is the lowest meaning "no burden" and a value of 10 meaning "Worst imaginable burden"
Measured: Baseline to day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start4 Mar 2025
- Primary completion17 Mar 2026
- Study completion17 Mar 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 Pneumonia (CAP)Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen Respiratory Research
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jens-Ulrik S. Jensen, Professor, MD, phD, Study director, Copenhagen Respiratory Research, Department of Clinical medicine Copenhagen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859450
- Sponsor's protocol ID
- EU-CT: 2024-511413-37-00
- Other IDs
- 2024-511413-37-00
- Acronym
- LANDCAP-1
- Status last verified
- Oct 2026
- First submitted
- 28 Feb 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of the trial will be published regardless of whether they are positive, negative, or inconclusive. The trial will be registered and published at clinicaltrials.gov as well as published in an international peer-reviewed scientific journal. Irrespective of the outcome of a clinical trial, within one year from the end of a clinical trial we will submit to the EU database (CTIS) a summary of the results of the clinical trial accompanied by a summary written in a manner that is understandable to laypersons. If publication in a scientific journal is not possible, the results will be published as an online report.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Antibiotic Delivery for Community Acquired Pneumonia - Pilot Study (LANDCAP1)
- ClinicalTrials.gov ID
- NCT06859450
- Acronym / sponsor ID
- LANDCAP-1 / EU-CT: 2024-511413-37-00
- Conditions
- Community Acquired Pneumonia (CAP)
- Keywords
- Community Acquired Pneumonia, Inhaled levofloxacin, Inhaled antibiotics, feasibility, Chronic obstructive pulmonary disease, asthma, pulmonary healthy, pilot study
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Copenhagen Respiratory ResearchResearch network
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2029 (estimated)
- First posted
- 5 Mar 2025 (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.
A randomized, double-blinded clinical pilot study to assess whether addition of inhaled levofloxacin 240 mg twice daily for three days leads to improved or worsened physiological status in CAP patients with and without pre-existing lung disease.
Detailed description
RATIONALE Community-acquired pneumonia (CAP) is a common and potentially severe disease placing a substantial burden on patients and healthcare systems. At the core of the current treatment of CAP is oral or intravenous antibiotics. This poses challenges, both to the individual patient in the form of side-effects due to the antibiotic affecting unintended tissues, as well as to society as current antibiotic prescription patterns may be problematic in the long term due to increasing antimicrobial resistance. Thus, there is a need for alternative treatments that minimize side-effects while reducing the drive of antimicrobial resistance.
The investigators propose inhaled antibiotics as a new treatment modality for CAP. Inhaled administration greatly increases the antibiotic concentration in the lungs, potentially increasing efficacy, while decreasing concentrations in other tissues, potentially reducing side-effects. Especially the gut is important in this regard, as the gut microbiome is much larger than the lung microbiome, therefore the investigators expect that inhaled treatment causes much smaller antibiotic exposure to the bystander bacteria in the gut compared to systemic treatment, reducing antimicrobial resistance selection.
Though results from this study will likely be applicable to other antibiotics, the investigators have specifically chosen to investigate inhaled levofloxacin as it is marketed and has the most favourable side-effect and microbial coverage profile for CAP. Inhaled levofloxacin has been marketed for chronic lung infections since 2015. If the investigators find that inhaled treatment is viable, the investigators hope it will open the path for new inhaled formulations specifically designed for CAP.
To ensure patient safety, the investigators have planned this trial as a small safety trial in which the investigators explore inhaled levofloxacin as an add-on therapy to systemic treatment to collect data on infection control and physiological effects of the drug in a population of CAP patients with or without respiratory comorbidity. These findings will be used in the conduct of a follow-up efficacy trial comparing inhaled treatment to systemic treatment.
The investigators hypothesize that add-on of three days (6 doses over 72 hours) of inhaled levofloxacin to guideline-based treatment of patients with CAP with and without pulmonary comorbidity compared to guideline-based therapy alone is safe and does not cause a worsening of respiratory function defined as decrease in forced end-expiratory volume first second (FEV1).
Further, the investigators hypothesize that such an intervention will lead to comparable disease control defined as an equal number of patients with increasing C-reactive protein, procalcitonin or persistent fever after three days or new onset critical illness.
OBJECTIVES The objective of this study is to determine if addition of inhaled levofloxacin 240 mg twice daily for three days leads to improved or worsened physiological or infectious status in CAP patients with and without pre-existing lung disease.
TRIAL DESIGN A double-blinded randomised controlled trial testing the tolerability and safety of inhaled Levofloxacin in patients admitted to hospital with moderate to severe community-acquired pneumonia.
This study will enrol in total 36 patients:
Of these, all shall have a community-acquired pneumonia (see inclusion criteria below for specific criteria)
Further:
12 subjects with specialist-verified asthma and no other concomitant pulmonary comorbidities.
12 subjects with specialist-verified chronic obstructive pulmonary disease and no other concomitant pulmonary comorbidities.
12 subjects that do not have any pulmonary comorbidities.
INTERVENTION All patients will recieve guideline-based treatment for community-acquired pneumonia. Patients will be randomized 1:1 to recieve blinded add-on treatment with either placebo (saline) or active inhaled levofloxacin 240mg (antibiotic) twice daily for up to 3 days.
All subjects will have the airflow tested before and after their first inhaled treatment and again before discharge or at day 4, whichever comes first.
WORKFLOW Following informed consent, trial participants will fill out a questionnaire about general health status, medicine and comorbidity and the patient's height and weight will be recorded. Furthermore, an electrocardiogram (ECG) will be obtained. For female participants under the age of 55 years who have had a menstruation within 12 months and are not permanently sterile, a pregnancy test will be conducted as part of the screening process. In addition to this, a baseline bedside spirometry will be performed.
The participants will receive a total of 6 inhalations over the course of 72 hours. An investigator or other hospital staff will assist with the medicine administration. Approximately one hour following each inhalation an investigator will perform a clinical assessment of the participant.
SAMPLE SIZE The primary objective of this trial is to evaluate the safety and feasibility of administering inhaled levofloxacin for the treatment of CAP. Additionally the trials aim to gather data and insights to inform the design and implementation of the subsequent main trial (Trial II). To achieve this, the investigators have opted for a conservative patient cohort size. It is recommended to include at least 30 patients in pilot studies, to be able to estimate the standard deviation of population parameters. Therefore, the investigators have chosen to enrol 36 patients stratified by comorbidity in order to ensure robust data collection and analysis.
PUBLICATIONS OF TRIAL RESULTS The results of the trial will be published regardless of whether they are positive, negative, or inconclusive. The trial will be registered and published at clinicaltrials.gov as well as published in an international peer-reviewed scientific journal. Irrespective of the outcome of a clinical trial, within one year from the end of a clinical trial the investigators will submit to the EU database (CTIS) a summary of the results of the clinical trial accompanied by a summary written in a manner that is understandable to laypersons.
If publication in a scientific journal is not possible, the results will be published as an online report.
ETHICAL CONSIDERATIONS Community-acquired pneumonia is a serious and deadly disease which is a great burden on both patients and healthcare systems, and mortality from this condition is still very high. Furthermore, current treatments may not be sustainable in the future due to increasing antimicrobial resistance, which may eventually lead to increasing mortality due to a lack of treatment options.
This study is the first in a line of studies that aims to determine if inhaled antibiotics are a safe, tolerated and an effective way of treatment for a very common and serious disease. Inhaled levofloxacin has been marketed since 2015 and severe adverse events is rare. Overall this study is safe to be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Asthma - Active | Active comparator | Drug: LevofloxacinAdmitted asthma patient recieving active inhalations |
| Asthma - Placebo | Placebo comparator | Drug: PlaceboAdmitted asthma patient recieving placebo inhalations |
| Chronic obstructive pulmonary disease - Active | Active comparator | Drug: LevofloxacinAdmitted COPD-patient recieving active inhalations |
| Chronic obstructive pulmonary disease - Placebo | Placebo comparator | Drug: PlaceboAdmitted COPD-patient recieving placebo inhalations |
| Pulmonal healthy - Active | Active comparator | Drug: LevofloxacinAdmitted pulmonary healthy patient recieving active inhalations |
| Pulmonal healhty - Placebo | Placebo comparator | Drug: PlaceboAdmitted pulmonary healthy patient recieving placebo inhalations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hospital admission within 24 hours.
- Radiologically new-onset chest infiltrate that is consistent with pneumonia and symptoms or signs also consistent with pneumonia, such as fever, cough, sputum, dyspnoea and/or chest pain
- CURB-65 score 3-5
- C-reactive protein >50 OR central body temperature >38.0 °C (1-2 of these fulfilled)
- Age ≥ 18 years
Key exclusion criteria (13 listed)
- Septic shock according to the sepsis III criteria:41 sequential organ failure assessment (SOFA) score ≥2) and suspected infection (according to attending physician) and persisting hypotension requiring vasopressors to maintain MAP≥65 mmHg and serum lactate level>2 mmol/L (18 mg/dL) despite adequate volume resuscitation (30 mL/kg crystalloid within 3 hours).
- Oxygen requirement ≥5 L/min to maintain acceptable saturation assessed by the treating physician.
- Respiratory rate >24/min with relevant oxygen therapy
- Positive COVID or influenza test (PCR or antigen test)
- Known allergy to levofloxacin or other fluoroquinolones or a serious adverse reaction when previously treated with a fluoroquinolone, including tendinitis or tendon-rupture related to fluoroquinolone treatment
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 |
|---|---|---|
| LevofloxacinAdd-on treatment of inhaled Levofloxacin 240mg twice daily or placebo (saline) twice daily for up to 3 days while admitted. | Drug | Asthma - Active, Chronic obstructive pulmonary disease - Active, Pulmonal healthy - Active |
| PlaceboAdd-on treatment of inhaled Levofloxacin 240mg twice daily or placebo (saline) twice daily for up to 3 days while admitted. | Drug | Asthma - Placebo, Chronic obstructive pulmonary disease - Placebo, Pulmonal healhty - Placebo |
Primary outcome
Change in FEV1 after first inhalation from baseline
Time frame: Enrollment to second assessment - 1 hour
Proportion of patients with a drop in FEV1 of 20% or 300mL one hour following the first inhalation.
6 secondary outcomes
Change in FEV1 from baseline to day 4 or discharge
Time frame: From baseline to day 4 or discharge. Between 24-72 hours.
C-reactive protein (CRP) on day 4 higher than any day from baseline to day 3.
Time frame: Baseline to day 4
Physiological status at day 4
Time frame: Day 4 assessment
Procalcitonin day 4 compared to any day before including baseline
Time frame: Baseline to day 4
Temperature at day 4 above 38 degrees celcius
Time frame: Day 4 assessment
Patient reported change fra baseline to day 4
Time frame: Baseline to day 4
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 6 Nov 2026.
- Individual participant dataSharing planned: Yes. The results of the trial will be published regardless of whether they are positive, negative, or inconclusive. The trial will be registered and published at clinicaltrials.gov as well as published in an international peer-reviewed scientific journal. Irrespective of the outcome of a clinical trial, within one year from the end of a clinical trial we will submit to the EU database (CTIS) a summary of the results of the clinical trial accompanied by a summary written in a manner that is understandable to laypersons. If publication in a scientific journal is not possible, the results will be published as an online report.
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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.
Jens-Ulrik S. Jensen, Professor, MD, phD study director
Copenhagen Respiratory Research, Department of Clinical medicine Copenhagen University
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 Levofloxacin in people with Community Acquired Pneumonia (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 6 inclusion and 13 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 6 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. Some participants in this study may receive a placebo. 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?
Change in FEV1 after first inhalation from baseline (time frame: Enrollment to second assessment - 1 hour). 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 6 Nov 2026.