Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia

NCT07843017 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2024-511420-13-00
• Study Type: interventional
• Target: 460
• Locations: 0 countries
• Sites: N/A

Brief 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. 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:

1. 1.Does treatment with inhaled levofloxacin reduce proportion of patients with antibiotic side-effects?
2. 2.Does treatment with inhaled levofloxacin lead to preserved diversity in the gut microbiome?
3. 3.Is treatment with inhaled levofloxacin comparable with usual care in regards to patient reported outcomes?

Conditions

CAP; Community Acquired Pneumonia; Pneumonia; Microbial Composition; Community-acquired Pneumonia

Keywords

Inhaled antibiotics; Nebulized antibiotics; Aerosolized antibiotics; Levofloxacin; Flourquinolone; CAP; Pneumonia; Community-acquired; Community acquired

Outcome Measures

Primary Outcomes (1)

• DAOH14

  Days alive and out of hospital day 14

  From inclusion to 14 days after

Study Arms (2)

Standard-of-care (Control)

ACTIVE COMPARATOR

Systemic antibiotic treatment

Drug: Standard-of-care / Usual care

Inhaled levofloxacin

EXPERIMENTAL

Drug: Inhaled levofloxacin

Interventions

Inhaled levofloxacin DRUG

Inhaled levofloxacin 240mg twice daily

Inhaled levofloxacin

Standard-of-care / Usual care DRUG

Standard-of-care / Usual care deemed of antibiotic treatment for community-acquired pneumonia assessed by the treating physician

Standard-of-care (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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\*\*.

Sponsors & Collaborators

• Copenhagen Respiratory Research: lead

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jens-Ulrik S Jensen, Professor, PhD, Medical Doctor

  Copenhagen Respiratory Research

  STUDY DIRECTOR

Central Study Contacts

Alexander R Jordan, Medical Doctor, PhD-fellow

CONTACT

+4540182345; alexander.ryder.jordan@regionh.dk

Bård-Emil V Gundersen, Medical Doctor, PhD-fellow

CONTACT

+4526193952; baard-emil.vang.gundersen@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: At earliest 1 year after Last patients last visit.
• Access Criteria: To be determined