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

Study acronym: LANDCAP 2
StatusNot Yet Recruiting
PhasePhase 2/3
Started
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Record History

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  1. Study title shortened, about 10 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07843017
Lead Sponsor Copenhagen Respiratory Research
Conditions
(from sponsor)		 Community-acquired Pneumonia, CAP, Community Acquired Pneumonia, Pneumonia, Microbial Composition
Related terms Community-Acquired Pneumonia, Pneumonia
Enrollment 460 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov