Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCopenhagen Respiratory Research
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hospital admission within 24 hours.
Clinical suspicion of community-acquired pneumonia necessitating antibiotic treatment.
Chest X-ray, CT or ultrasound findings consistent with bacterial pneumonia*
Symptoms consistent with bacterial pneumonia (such as dyspnea, tachypnea, cough or purulent sputum)
Disqualifiers
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
Known allergy to fluoroquinolones or a serious adverse reaction when previously treated with a fluoroquinolone.
Trial design
Design model
Parallel
Treatments tested in this trial
Inhaled levofloxacin
DrugInhaled levofloxacin 240mg twice daily
Standard-of-care / Usual care
DrugStandard-of-care / Usual care deemed of antibiotic treatment for community-acquired pneumonia assessed by the treating physician
Treatment groups
460 Participants
are divided into 2 treatment groupsGroup A: Standard-of-care (Control)Active comparator 1 intervention
Group B: Inhaled levofloxacinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
DAOH14
Days alive and out of hospital day 14
Time frame
From inclusion to 14 days afterLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: