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

25 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Geschat)

460

Fase

  • Fase 2
  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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**.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Standard-of-care (Control)

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

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

Inhaled levofloxacin 240mg twice daily

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
DAOH14
Tijdsspanne: From inclusion to 14 days after

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Copenhagen Respiratory Research

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

28 september 2026

Primaire voltooiing (Geschat)

1 september 2028

Studie voltooiing (Geschat)

1 september 2029

Studieregistratiedata

Eerst ingediend

21 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 september 2026

Eerst geplaatst (Werkelijk)

25 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 september 2026

Laatste update ingediend die voldeed aan QC-criteria

25 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

At earliest 1 year after Last patients last visit.

IPD-toegangscriteria voor delen

To be determined

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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