Local Antibiotic Delivery for Community Acquired Pneumonia - Pilot study (LANDCAP1)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Gentofte Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

3 Mar 2025 → ongoing

Decision date (initial)

2024-06-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk Foundation

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

The objective of this study is to determine if addition of inhaled levofloxacin 240 mg twice daily for three days leads to improved or worsened physiological or infectious status in CAP patients with and without pre-existing lung disease.

Conditions and MedDRA coding

Community-acquired pneumonia

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Hospital admission within 24 hours.
2. Radiologically new-onset chest infiltrate that is consistent with pneumonia and symptoms or signs also consistent with pneumonia, such as fever, cough, sputum, dyspnoea and/or chest pain
3. C-reactive protein >50 OR central body temperature >38.0 °C (1-2 of these fulfilled)
4. Age ≥ 18 years
5. Able to give informed consent

Exclusion criteria 12

1. Septic shock according to the sepsis III criteria:41 sequential organ failure assessment (SOFA) score ≥2) and suspected infection (according to attending physician) and persisting hypotension requiring vasopressors to maintain MAP≥65 mmHg and serum lactate level>2 mmol/L (18 mg/dL) despite adequate volume resuscitation (30 mL/kg crystalloid within 3 hours).
2. Oxygen requirement ≥5 L/min to maintain acceptable saturation assessed by the treating physician.
3. Respiratory rate >24/min with relevant oxygen therapy
4. Positive COVID or influenza test (PCR or antigen test)
5. Known allergy to levofloxacin or other fluoroquinolones or a serious adverse reaction when previously treated with a fluoroquinolone, including tendinitis or tendon-rupture related to fluoroquinolone treatment
6. Unexplained symptoms of neuropathy (peripheral paraesthesia, hypoesthesia, or hyperalgesia)
7. Medical history of myasthenia gravis
8. Reduced kidney function (eGFR < 20)
9. A clinical state where the physician believes that chance of survival for 48 hours at time of recruitment is minimal.
10. Suspected aspiration pneumonia, pulmonary abscess, or pleural empyema / complicated parapneumonic effusion.
11. Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) > 480ms).
12. Pregnancy (a negative pregnancy test is required prior to inclusion of all pre-menopausal women)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients with a drop in FEV1 of 20% or 300mL one hour following the first inhalation.

Secondary endpoints 6

1. Proportion of patients with a drop in FEV1 of 20% or 300mL from baseline to day 4 or discharge, whichever comes first.
2. CRP on day 4 higher than on any day from 1 to 3 including baseline.
3. MAP ≤ 65 OR respiratory frequency > 25 OR pulse > 100 OR needing supplemental oxygen (1-4 of these fulfilled) on day 4.
4. PCT on day 4 higher than baseline.
5. Temperature ≥ 38.0 °C on day 4.
6. Patient reported outcome measurements: Changes in Visual Analogue Scales for dyspnoea, cough and fatigue from baseline to day 4.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gentofte Hospital

Sponsor organisation

Gentofte Hospital

Address

Gentofte Hospitalsvej 1

City

Hellerup

Postcode

2900

Country

Denmark

Scientific contact point

Organisation

Gentofte Hospital

Contact name

Jens Ulrik Stæhr Jensen

Public contact point

Organisation

Gentofte Hospital

Contact name

Jens Ulrik Stæhr Jensen

Third parties 1

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications