Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia (LANDCAP 2)
Local Antibiotic Delivery for Community Acquired Pneumonia
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:
- Does treatment with inhaled levofloxacin reduce proportion of patients with antibiotic side-effects?
- Does treatment with inhaled levofloxacin lead to preserved diversity in the gut microbiome?
- 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Community-acquired pneumonia is common and potentially fatal. Standard-of-care treatment mainly consists of systemic antibiotics and treatment supporting recovery (e.g. oxygen-therapy, fluid rescucitation, respiratory physiotherapy, sufficient dietary intake etc.). As with all medicinal treatments, antibiotic treatment is hard on the body and can lead to side-effects as well as organ-failure in extreme cases.
Antibiotic treatment naturally promotes antimicrobial resistance (AMR), which result in less effective antibiotic treatment, and ultimately it could potentially lead to antibiotics being rendered useless in treating infections such as pneumonia.
A strategy to reduce the promotion of antimicrobial restistance (AMR) is better targeting of the disease-inducing microbes and several other strategies exists. Physicians and researchers usually categorize the targeting of disease-promoting microbes as either "local"/"topical" or "systemic". No "local" treatment of community-acquired pneumonia has been demonstrated to this day, but "local" treatment is theoretically possible with inhaled antibiotics. This treatment strategy has been hypothesized in the last decade, but no studies have been conducted regarding community-acquired pneumonia.
This study will include 460 patients and be conducted in two stages: Stage A and Stage B, each stage including 230 patients.
Patients are included voluntarilty and with prior written informed consent.
Patients included in stage A will be treated with systemic antibiotics for 24 hours and will then be randomized to further treatment with either inhaled levofloxacin 240mg twice daily or continue the "usual care"-treatment that they were receiving. The duration of intervention is up to 5 days.
At 230 included patients a planned interrim analysis will be conducted by an appointed data safety monitoring board of certified healthcare professionals to assess the further continuation of the trial. If favorable assessment, the trial will commence to Stage B.
Patients included in Stage B will be randomized at admission to either usual standard-of-care treatment for 5 days OR inhaled levofloxacin 240mg twice daily for 5 days.
The trial is open-label, which means that both patients and healthcare professionals will know which treatment arm the patient is receiving.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
- Fáze 3
Kontakty a umístění
Studijní kontakt
- Jméno: Alexander R Jordan, Medical Doctor, PhD-fellow
- Telefonní číslo: +4540182345
- E-mail: alexander.ryder.jordan@regionh.dk
Studijní záloha kontaktů
- Jméno: Bård-Emil V Gundersen, Medical Doctor, PhD-fellow
- Telefonní číslo: +4526193952
- E-mail: baard-emil.vang.gundersen@regionh.dk
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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**.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Standard-of-care (Control)
Systemic antibiotic treatment |
Standard-of-care / Usual care deemed of antibiotic treatment for community-acquired pneumonia assessed by the treating physician |
|
Experimentální: Inhaled levofloxacin
|
Inhaled levofloxacin 240mg twice daily |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
DAOH14
Časové okno: From inclusion to 14 days after
|
Days alive and out of hospital day 14 |
From inclusion to 14 days after
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Jens-Ulrik S Jensen, Professor, PhD, Medical Doctor, Copenhagen Respiratory Research
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2024-511420-13-00
- 2024-511420-13-00 (Ctis)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
All reasonable requests will be considered for pseudo-anonymized datasharing in accordance with applicable law of datasharing in the state of Denmark.
Časový rámec sdílení IPD
At earliest 1 year after Last patients last visit.
Kritéria přístupu pro sdílení IPD
To be determined
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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