Contact information
Type
Scientific
Primary contact
Dr Ingo Beyer
ORCID ID
Contact details
Geriatric Department
UZ Brussel
101 Laarbeeklaan
Brussels
1090
Belgium
+32 (0)2 476 3307
Ingo.Beyer@uzbrussel.be
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
NSAID treatment with piroxicam versus placebo in hospitalised geriatric patients with infection-induced inflammation - influence on muscle function: a single centre double blind randomised controlled trial
Acronym
Study hypothesis
The treatment with a non steroidal anti-inflammatory drug (NSAID) in addition to standard antibiotic therapy might attenuate infection-induced inflammation and reduce its negative effects on muscle function
Ethics approval
Hospital ethics committee (Comité d'éthique hospitalier), CHU Brugmann approved on 17/12/2004 and amendements approved on 19/05/2005 (N/Ref CE 2004/44)
Study design
Single centre double blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Infection-induced inflammation and related muscle weakness
Intervention
10 mg piroxicam daily versus placebo in addition to standard care including antibiotics
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Skeletal muscle mass (total body potassium) evaluated at baseline & weekly thereafter maximum two times
2. Muscle performance (grip strength, fatigue resistance and Elderly Mobility Scale (EMS) score evaluated at baseline & weekly thereafter with a maximum of three weeks
3. Inflammation (levels of cytokines and heat shock proteins) evaluated at baseline, daily during the first 3 days and weekly after baseline with a maximum of three weeks
Secondary outcome measures
1. Clinical evolution evaluated at discharge
2. Length of stay
3. Tolerance and adverse events evaluated daily throughout hospitalisation
Overall trial start date
01/05/2005
Overall trial end date
30/04/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients hospitalised in an acute geriatric ward
2. Age > 70 years
3. Inflammation, not due to surgery or burns, and documented by an increase of serum concentration of C-reactive protein (CRP) (> 10 mg/L) and/or fibrinogen (>400 mg/dL)
4. Informed consent
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. General condition, dementia or confusion, not allowing the testing
2. Patients in (pre) terminal phase
3. Use of corticosteroids or non -steroidal anti-inflammatory drugs (NSAIDs) in the past 7 days; the use of inhalation corticosteroids, of low dose aspirin (as anti-aggregating medication) or of paracetamol is allowed
4. Contra-indication for the use of cyclo-oxygenase (COX)-2 inhibitors
Recruitment start date
01/05/2005
Recruitment end date
30/04/2006
Locations
Countries of recruitment
Belgium
Trial participating centre
Geriatric Department
Brussels
1090
Belgium
Sponsor information
Organisation
Brussels University Hospital (Belgium) (Universitair Ziekenhuis Brussel)
Sponsor details
101 Laarbeeklaan
Brussels
1090
Belgium
germst@uzbrussel.be
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Brussels University Hospital (Belgium)-Scientific Willy Gepts Fund ("Wetenschappelijk Fonds Willy Gepts" of the Universitair Ziekenhuis Brussel)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Brugmann University Hospital Brussels Centre (Belgium) (Centre Hospitalier Universitaire Brugmann and Universitair Ziekenhuis Brussel, Brussels)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22057579
Publication citations
-
Results
Beyer I, Njemini R, Bautmans I, Demanet C, Mets T, Immunomodulatory effect of NSAID in geriatric patients with acute infection: effects of piroxicam on chemokine/cytokine secretion patterns and levels of heat shock proteins. A double-blind randomized controlled trial. (ISRCTN58517443)., Cell Stress Chaperones, 2012, 17, 2, 255-265, doi: 10.1007/s12192-011-0304-4.