Activity of platelets in patients recovering from severe infectio
- Conditions
- Infectious diseases
- Registration Number
- NL-OMON21579
- Lead Sponsor
- Vrije Universiteit Medisch Centrum Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 97
In order to be eligible to participate in the main-trial, a subject must meet all of the following criteria:
Primary clinical diagnosis of pneumonia
OR
Primary clinical diagnosis of invasive urinary tract infection
OR
Primary clinical diagnosis of cutaneous infection
AND
18 years or older on the date of hospital presentation
AND
Hospitalization for at least 24 hours
AND
Having received at least 1 dose of antibiotics within 48 hours of admission.
In order to be eligible to participate in the sub-study, a subject must meet all of the following criteria:
Primary clinical diagnosis of pneumonia
OR
Primary clinical diagnosis of invasive urinary tract infection
OR
Primary clinical diagnosis of cutaneous infection
AND
18 years or older on the date of hospital presentation
AND
Hospitalization for at least 24 hours
AND
Having received at least 1 dose of antibiotics within 48 hours of admission
AND
Known stable cardiovascular disease. Stable cardiovascular disease defined as: coronary artery disease, peripheral vascular disease, or previous myocardial infarction (>12 months).
AND
Chronic usage of 80 mg of non-enteric coated acetylsalicylic acid once daily in the
morning.
A potential subject who meets any of the following criteria will be excluded from participation in the main-trial:
-Active metastatic cancer (c.q. malignancy)
-Allergy to salicylate
-Platelet count <120*109/l
-History of non-traumatic major bleeding
-Known bleeding diathesis
-Conditions which require antiplatelet therapy
-Usage of antiplatelet therapy
-Surgery 1 month prior to diagnosis
-Currently pregnant
-Chronic usage of medication which are known to influence
platelet function other than antibiotics (e.g. NSAID’s, tirofiban, eptifibatide, abciximab, SSRI’s, clomipramine, amitriptyline, dipyridamole, verapamil, diltiazem , ginkgo biloba, ginseng, & St John’s wort)
A potential subject who meets any of the following criteria will be excluded from participation in the sub-study:
-Active metastatic cancer (c.q. malignancy)
-Platelet count <120*109/l
-History of non-traumatic major bleeding
-Known bleeding diathesis
-Surgery 1 month prior to diagnosis
-Currently pregnant
-Cardiovascular event < 12 months prior
-Chronic usage of medication which are known to influence
platelet function other than antibiotics or aspirin (e.g. NSAID’s, tirofiban, eptifibatide, abciximab, SSRI’s, clomipramine, amitriptyline, dipyridamole, verapamil, diltiazem , ginkgo biloba, ginseng, & St John’s wort)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Platelet aggregability, measured by:<br /><br>- PFA-200 parameters (closure time, flow slope, maximum rate of occlusion, area under the curve)<br /><br>- TBX2 serum levels
- Secondary Outcome Measures
Name Time Method - Laboratory endpoints: platelet-, reticulared platelet-, leucocyte count, CRP, BSE, haemoglobin level<br /><br>- Cardiovascular events