sing Simvastatin to improve immune responses in older people with pneumonia

Phase 1

• Conditions: Acute episodes of Pneumonia and sepsis in older adults; MedDRA version: 14.1 Level: PT Classification code 10035664 Term: Pneumonia System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-003343-29-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-26
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 56

Inclusion Criteria

Inclusion Criteria 1. Age > 60 years 2. Patients with a diagnosis of community acquired pneumonia. We will use the British Thoracic Society definition of pneumonia; defined as symptoms and signs consistent with an acute lower respiratory tract infection associated with new radiographic shadowing for which there is no other explanation”. We will include symptoms and signs as having 3 or more of the following: cough, sputum production, breathlessness, pleuritic chest pain, haemoptysis, fever, headache, signs consistent with pneumonia on chest auscultation. 3. Pneumonia patients will also need to meet the criteria for sepsis based on the standard definitions as published in the 2008 Surviving Sepsis Campaign Guidelines.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

Exclusion Criteria

Exclusion criteria • More than 48 hours from admission at time of consent. • Current or recent statin use within 1 month. • known prior myositis. • creatinine kinase >10 times upper limit normal range* • transaminases (ALT/AST) >8 times upper limit of normal range* • severe renal impairment (creatinine clearance <30ml/min) not receiving renal replacement therapy • patients currently receiving ongoing and sustained treatment with any of the following: itraconazole, ketoconazole, HIV protease inhibitors, nefazodone, ciclosporine, amiodarone, verapamil or diltiazem. Fibric acid derivatives (except fenofibrate), danazol. • A family history of muscular disorders. • Known HIV or hepatitis B/C infection. • Contraindication to enteral drug administration (either PO or Per NG) e.g. patients with mechanical bowel obstruction. • Known participation in other investigational medicinal product (IMP_ trials within 30 days. • Consent / relative or advocate assent declined. • Treatment withdrawal imminent within 24 hours. •Immunosuppression due to corticosteroid or other immunosuppressant use • Patient declines consent • Personal Consultee, when available, does not provide assent • Porfessional Consultee, if used, does not provide assent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified