Comparison of the effect of shortened versus standard antibiotic treatment in patients hospitalized with pneumonia

Phase 1

Conditions: Community-acquired pneumonia
MedDRA version: 22.1Level: LLTClassification code 10035725Term: Pneumonia NOSSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2019-000404-15-DK

Lead Sponsor: Thomas Benfield

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 336

Inclusion Criteria

o Hospitalized with community-acquired pneumonia; defined as new pulmonary infiltrate on chest X-ray and at least one symptom compatible with pneumonia (cough, fever, dyspnoea and/or chest pain)
o Initiation of antibiotics within 12 hours of the time of the chest X-ray with an infiltrate
o Age = 18 years
o Afebrile (temp = 37,8°C) for 48 hours at randomization
o Clinically stable at randomization (SBP = 90 mm Hg, HR = 100/min., RR = 24/min., SAT = 90%)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 168
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 168

Exclusion Criteria

a) Immunosuppression (HIV-positive, neutropenia (<1 x 10^9/L), corticosteroid treatment (= 10 mg/d of prednisone or the equivalent for >30 days), chemotherapy within the past 90 days, untreated terminal cancer, immunosuppressive agents, immunosuppressed after solid organ transplantation, asplenia)
b) Hospitalization during the previous 14 days
c) Antibiotic treatment (>2 days) within the past 30 days, directed at lower respiratory tract pathogens
d) Uncommon cause requiring longer duration of antimicrobial therapy (Pseudomonas aeruginosa, Staphylococcus aureus, Mycobacterium spp., fungi)
e) Extrapulmonary infection (e.g. endocarditis, meningitis, or abscess)
f) Pleural empyema or lung abscess
g) Pleural effusion requiring drainage tube
h) Intensive care unit (ICU) admittance
i) Pregnancy and breastfeeding

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy and safety of shortened antibiotic treatment duration of community-acquired pneumonia in hospitalized immunocompetent adult patients based on clinical stability criteria in a beta-lactam antibiotic setting;Secondary Objective: To reduce the consumption of antibiotics and thereby potentially decrease the risk of adverse events, obtain better patient adherence, reduce antimicrobial resistance and health care costs. ;Primary end point(s): Survival;Timepoint(s) of evaluation of this end point: 90 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Duration of antibiotic treatment<br>2. Length of hospital stay<br>3. Antibiotic adverse events<br>4. Serious adverse events (according to ICH-GCP guidelines)<br>5. Major complications (pleural effusion, pleural empyema, lung abscess, respiratory failure, severe sepsis, renal failure, use of non-invasive or invasive ventilation, need for vasopressors, ICU admission)<br>6. Use of antimicrobials after discharge<br>7. Post-discharge follow-up visits<br>8. Readmission within 30 and 90 days<br>8a. Pneumonia related readmission within 30 and 90 days<br>9. Mortality<br>9a. In-hospital mortality<br>9b. 30-day all-cause mortality<br>9c. 90-day all-cause mortality;Timepoint(s) of evaluation of this end point: 90 days