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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Szacowany)
Faza
- Faza 2
- Faza 3
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Alexander R Jordan, Medical Doctor, PhD-fellow
- Numer telefonu: +4540182345
- E-mail: alexander.ryder.jordan@regionh.dk
Kopia zapasowa kontaktu do badania
- Nazwa: Bård-Emil V Gundersen, Medical Doctor, PhD-fellow
- Numer telefonu: +4526193952
- E-mail: baard-emil.vang.gundersen@regionh.dk
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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**.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: 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 |
|
Eksperymentalny: Inhaled levofloxacin
|
Inhaled levofloxacin 240mg twice daily |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
DAOH14
Ramy czasowe: From inclusion to 14 days after
|
Days alive and out of hospital day 14 |
From inclusion to 14 days after
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Jens-Ulrik S Jensen, Professor, PhD, Medical Doctor, Copenhagen Respiratory Research
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2024-511420-13-00
- 2024-511420-13-00 (Ctis)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
All reasonable requests will be considered for pseudo-anonymized datasharing in accordance with applicable law of datasharing in the state of Denmark.
Ramy czasowe udostępniania IPD
At earliest 1 year after Last patients last visit.
Kryteria dostępu do udostępniania IPD
To be determined
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .