Local Antibiotic Delivery for Community Acquired Pneumonia

NCT06859450 | Not Yet Recruiting Phase 2

• 2 other identifiers: EU-CT: 2024-511413-37-002024-511413-37-00
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Community Acquired Pneumonia (CAP)

Keywords

Community Acquired Pneumonia; Inhaled levofloxacin; Inhaled antibiotics; feasibility; Chronic obstructive pulmonary disease; asthma; pulmonary healthy; pilot study

Outcome Measures

Primary Outcomes (1)

• 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.

  Enrollment to second assessment - 1 hour

Secondary Outcomes (6)

• Change in FEV1 from baseline to day 4 or discharge

  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.

  Baseline to day 4

• Physiological status at day 4

  Day 4 assessment

• Procalcitonin day 4 compared to any day before including baseline

  Baseline to day 4

• Temperature at day 4 above 38 degrees celcius

  Day 4 assessment

Study Arms (6)

Asthma - Active

ACTIVE COMPARATOR

Admitted asthma patient recieving active inhalations

Drug: Levofloxacin

Asthma - Placebo

PLACEBO COMPARATOR

Admitted asthma patient recieving placebo inhalations

Drug: Placebo

Chronic obstructive pulmonary disease - Active

ACTIVE COMPARATOR

Admitted COPD-patient recieving active inhalations

Drug: Levofloxacin

Chronic obstructive pulmonary disease - Placebo

PLACEBO COMPARATOR

Admitted COPD-patient recieving placebo inhalations

Drug: Placebo

Pulmonal healthy - Active

ACTIVE COMPARATOR

Admitted pulmonary healthy patient recieving active inhalations

Drug: Levofloxacin

Pulmonal healhty - Placebo

PLACEBO COMPARATOR

Admitted pulmonary healthy patient recieving placebo inhalations

Drug: Placebo

Interventions

Levofloxacin DRUG

Add-on treatment of inhaled Levofloxacin 240mg twice daily or placebo (saline) twice daily for up to 3 days while admitted.

Asthma - Active; Chronic obstructive pulmonary disease - Active; Pulmonal healthy - Active

Placebo DRUG

Add-on treatment of inhaled Levofloxacin 240mg twice daily or placebo (saline) twice daily for up to 3 days while admitted.

Asthma - Placebo; Chronic obstructive pulmonary disease - Placebo; Pulmonal healhty - Placebo

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.
• 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.

You may not qualify if:

• 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)
• 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).

Sponsors & Collaborators

• Copenhagen Respiratory Research: lead

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pulmonary Disease, Chronic Obstructive; Asthma

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jens-Ulrik S. Jensen, Professor, MD, phD

  Copenhagen Respiratory Research, Department of Clinical medicine Copenhagen University

  STUDY DIRECTOR

Central Study Contacts

Bård-Emil V. Gundersen, Medical Doctor

CONTACT

+45 26193952; baard-emil.vang.gundersen@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: March 4, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR