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NOT YET RECRUITING
NCT07843017
PHASE2/PHASE3

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

Sponsor: Copenhagen Respiratory Research

View on ClinicalTrials.gov

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. Does treatment with inhaled levofloxacin reduce proportion of patients with antibiotic side-effects? 2. Does treatment with inhaled levofloxacin lead to preserved diversity in the gut microbiome? 3. 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.

Official title: Local Antibiotic Delivery for Community Acquired Pneumonia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

460

Start Date

2026-09-28

Completion Date

2029-09-01

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

DRUG

Inhaled levofloxacin

Inhaled levofloxacin 240mg twice daily

DRUG

Standard-of-care / Usual care

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