25 results
The aim of this study is to test the hypothesis that a gentamicin-collagen sponge reduces the incidence of surgical site infection (SSI) in patients undergoing inguinal dissection for vascular disease
Primary: Long term safety and tolerability.Secondary: Time to 1st flare, number and severity of flares, efficiacy in treating flares, effect on inflammatory markers, immunogenicity, PK.
The primary objectives of this study are:Part II: to demonstrate that the time to flare in Part II is higher with canakinumab than with placebo.Part I: to assess if canakinumab allows tapering of steroids as per protocol in at least 25% of…
Primary: To determine whether IL-1 inhibition by Canakinumab is efficacious in treatment of Schnitzler syndrome.Secondary:1. To assess the effect of canakinumab on Schnitzler syndrome (clinical signs/symptoms and inflammatory biomarkers C-reactive…
The primary objective of this study is:To demonstrate that the percentage of patients who meet the adapted ACR Pediatric 30 criteria at Day 15 is higher with canakinumab compared to placebo.Secondary objectives of this study are:* To evaluate the…
Primary: Longterm safety and tolerability.Secondary: Time to 1st flare, number and severity of flares, efficiacy in treating flares, effect on inflammatory markers, immunogenicity, PK.
Primary: to demonstrate the superiority of at least one dose of canakinumab compared to placebo in reducing the risk of recurrent major cardiovascular disease events (cardiovascular death, non-fatal MI and stroke) in a population of clinically…
Primary: To confirm that canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to patient*s assessment of gout pain intensity in the target joint at 72 hours post-dose (on a 0-100mm VAS). To confirm that canakinumab…
The purpose of this open-label phase III extension study is to collect additional long term safety and efficacy data on canakinumab in the treatment of SJIA from patients who qualify to roll-over into this study from the CACZ885G2305 and…
Primary: To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future dosesSecondary:* To characterize the pharmacokinetic profile of each investigational drug within each treatment arm…
Primary objectivesTo determine the bacterial eradication capacity of ertapenem, fosfomycine and gentamicine compared to the reference treatment (ceftriaxone) in uncomplicated anogenital gonococcal infections (at one included infection site) by…
Primary: Safety run-in part (part 1):* to confirm tthe recommended Phase 3 dose regimen (RP3R) of canakinumab in combination with docetaxel. Double-blind, randomized, placebo-controlled part (part 2):* to compare the overall survival (OS) between…
The primary objective of the present study is to assess the feasibility and safety of a newly developed PET-guided breast biopsy system in breast cancer patients.
Primary objective: To study the pharmacokinetics of gentamicin, tobramycin, vancomycin and ciprofloxacin in morbidly obese patients and compare with normal weight patients. Secondary objectives: To assess the influence of covariates (such as TBW,…
Primary: The primary objective of the randomized treatment epoch and for the overall study is to demonstrate that subcutaneous canakinumab administered every 4 weeks is superior to placebo in achieving a clinically meaningful reduction of disease…
The aim of our study is to evaluate clinical outcomes of patients primarily closed over Redon catheters for the treatment of PSM, comparing the application of local gentamicin with a control group.
1. What is the complication rate of the initial antibiotic treatment strategy for acute simple appendicitis (radiological proven) in children aged 7-17 years old?
To compare the effect of IT dexamethasone versus IT gentamicin on number and severity vertigo attacks.To compare the effects of IT dexamethasone with IT gentamicin on hearing function, functional level scale and aural fullness.
To assess the effect of ACZ885 on AAA size and growth rate as measured with ultrasound at 12 months.Secondary Objectives * To assess the safety and tolerability of monthly 150 mg subcutaneousdoses of ACZ885 in subjects with AAA over a treatment…
Objective: The main objective is to demonstrate superiority of the intravesical overnight instillation of gentamicin versus oral antibiotic prophylaxis in reducing the number of recurrences of UTI and extending the time-interval to a next UTI, in…