Community-acquired pneumonia MedDRA version: 22.1 Level: LLT Classification code 10035725 Term: Pneumonia NOS System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Amoxicillin
Other descriptive name: AMOXICILLIN TRIHYDRATE
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceut
Sponsors
Thomas Benfield
Eligibility
Sex/Gender
All
Inclusion criteria
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 197 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 198
Exclusion criteria
Exclusion criteria: a) Immunosuppression (HIV-positive, neutropenia (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Duration of antibiotic treatment 2. Length of hospital stay 3. Antibiotic adverse events 4. Serious adverse events (according to ICH-GCP guidelines) 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) 6. Use of antimicrobials after discharge 7. Post-discharge follow-up visits 8. Readmission within 30 and 90 days 8a. Pneumonia related readmission within 30 and 90 days 9. Mortality 9a. In-hospital mortality 9b. 30-day all-cause mortality 9c. 90-day all-cause mortality;Timepoint(s) of evaluation of this end point: 90 days | — |
Countries
Denmark
Contacts
Public ContactSimone Bastrup Israelsen
Thomas Benfield
Outcome results
None listed