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Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia (LANDCAP 2)

4. november 2026 oppdatert av: Copenhagen Respiratory Research

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:

  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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

460

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Danmark
    • Capital Region
      • Gentofte Municipality, Capital Region, Danmark, 2820
        • Herlev and Gentofte University hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Hospital admission within 24 hours.

  2. 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)

  3. 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).

  4. Age ≥ 18 years.

  5. Able to give informed consent.

Exclusion Criteria:

  1. Suspected septic shock defined as MAP < 65 mmHg on sequential measurements despite adequate volume resuscitation.

  2. Oxygen requirement >4L/min to maintain acceptable peripheral oxygen saturation*.

  3. Significant suspicion of an infection with a focus other than the lungs

  4. 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.

  5. Reduced kidney function (eGFR < 20 mL/min/1.73 m²).

  6. Suspected aspiration pneumonia, pulmonary abscess, or pleural empyema / complicated parapneumonic effusion.

  7. Suspicion of clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) > 480ms).

  8. Pregnancy**.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Standard-of-care (Control)

Systemic antibiotic treatment
Legemiddel: Standard-of-care / Usual care

Standard-of-care / Usual care deemed of antibiotic treatment for community-acquired pneumonia assessed by the treating physician
Eksperimentell: Inhaled levofloxacin
Legemiddel: Inhaled levofloxacin

Inhaled levofloxacin 240mg twice daily

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
DAOH14
Tidsramme: From inclusion to 14 days after

Days alive and out of hospital day 14
From inclusion to 14 days after

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Copenhagen Respiratory Research

Etterforskere

  • Studieleder: Jens-Ulrik S Jensen, Professor, PhD, Medical Doctor, Copenhagen Respiratory Research

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

8. oktober 2026

Primær fullføring (Antatt)

1. september 2028

Studiet fullført (Antatt)

1. september 2029

Datoer for studieregistrering

Først innsendt

21. september 2026

Først innsendt som oppfylte QC-kriteriene

21. september 2026

Først lagt ut (Faktiske)

25. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2024-511420-13-00
  • 2024-511420-13-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

All reasonable requests will be considered for pseudo-anonymized datasharing in accordance with applicable law of datasharing in the state of Denmark.

IPD-delingstidsramme

At earliest 1 year after Last patients last visit.

Tilgangskriterier for IPD-deling

To be determined

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ANALYTIC_CODE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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