Foothill Rance, California

  • Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care

    Increasing emergence of multidrug resistant (MDR) bacteria worldwide is now considered one of the most urgent threats to global health. The association between increase of antibiotics consumption and resistance emergence has been well documented for all patients admitted to the Intensive care unit (ICU) who received antibiotic treatment1 and for patients treated for ventilator associated pneumonia (VAP). Reduction of use of antibiotics is a major point in the war against antimicrobial resistance. VAP is the first cause of healthcare-associated infections in ICU and more than half of antibiotics prescriptions in ICU are due to VAP. Current international guidelines define VAP as a pneumonia occurring>48 hours after endotracheal intubation and distinguishes early onset VAP occurring in the first five days after admission and late VAP, occurring after. Once the diagnosis of pneumonia under MV has been made, initiation of antibiotic treatment must be prompt but there is no clear consensus on its duration. In the case of a good clinical response to treatment, it has been shown in some situations that short course antibiotics can be effective without side effects and antimicrobial stewardship initiatives can be applied successfully and effectively to the management of Community Acquired Pneumonia (CAP). American guidelines strongly recommend a 7-day course of antibiotic therapy rather than a longer duration but remark that "there exist situations in which a shorter or longer duration of antibiotics may be indicated, depending upon the rate of improvement of clinical, radiologic, and laboratory parameters". The hypothesis is that an antimicrobial stewardship is possible in the treatment of VAP with no increase in the rate of all-cause mortality, treatment failure or occurrence of new episode of pneumonia. The objective is to investigate whether an antimicrobial stewardship for VAP based on daily assessment of clinical cure and antimicrobial discontinuation, if it is obtained, would be non-inferior in terms of all-cause mortality, treatment failure or occurrence of new episode of pneumonia. This study will be a prospective, national multicenter (31 centers), phase III, comparative randomized (1:1), single-blinded clinical trial comparing two management strategies of treatment of pneumonia on the basis of two parallel arms: Experimental group: Antimicrobial stewardship based on daily clinical assessment of clinical cure. Control group: standard management: duration of appropriate antibiotic therapy for confirmed VAP according to guidelines. The primary endpoint is a hierarchical endpoint with a first non-inferiority criteria and a second efficacy criteria.

    Phase

    N/A

    Span

    184 weeks

    Sponsor

    Assistance Publique - Hôpitaux de Paris

    Clichy-sous-Bois

    Recruiting

  • Melatonin for Prevention of Postoperative Delirium After Lower Limb Fracture Surgery in Elderly Patients

    Postoperative delirium (POD) is one of the most frequent complications after surgery in elderly patients, affecting between 20 and 40% of patients older than 60 after major surgery. This complication has huge consequences for the patients, families and society: increase of morbidity and mortality, prolonged length of stay, cognitive and functional decline leading to loss of autonomy, and important additional healthcare costs. Among numerous risk factors identified, perioperative inflammatory stress is a key element in delirium genesis: surgical trauma releases danger signals in systemic circulation, activating immune cells and leading to neuroinflammation. In the brain, especially in hippocampus, proinflammatory cytokines, immune cells recruitment and microglial activation alter synaptic plasticity and lead to acute cognitive dysfunction. Moreover, with aging, an increase in initial neuroinflammatory response and a decrease in subsequent resolution phase are observed. Melatonin is a neurohormone regulating circadian rhythm. But it also exhibits antioxidant and free radical scavenger properties, and regulates energy metabolism and immune function. It has already demonstrated a neuroprotective potential in various animal models. Its use against delirium is promising: it decreases delirium incidence in elderly patients hospitalized in medical ward, and several studies are now recruiting in ICU. Concerning the perioperative period, only two studies with conflicting results are available. The first one (Sultan, 2010), that has shown that melatonin decreases POD incidence, has strong methodological limitations (no calculated sample size, only 53 patients in melatonin group, all patients, even in the control group received melatonin if they developed POD, etc). In the second one (deJonghe, 2014), melatonin had no effect on POD incidence, but showed a reduction in the proportion of patients with POD exceeding 2 days. These conflicting results emphasize the need for a third RCT, with optimized methodology. The hypothesis of the trial is that in a high-risk population, perioperative melatonin can reduce the incidence of POD. The main objective is to evaluate the effect of perioperative melatonin administration on postoperative delirium incidence in the first 10 days after surgery, in elderly patients (over 70 years old) being hospitalized and scheduled for acute surgery of fractured lower limb (from femoral head to tibial plateau). This is a prospective, national multicentric (24 centers), phase III, superiority, comparative randomized (1:1) double-blinded clinical trial with two parallel arms: Experimental group: melatonin 4mg per os every night, starting the evening before surgery (or 2 hours before emergency surgery) and until day 5 after surgery. Control group: placebo of this drug with the same schedule, during the same period of time. The patients are aged 70 or older, hospitalized and scheduled for surgery of a severe fracture of a lower limb (from femoral head to tibial plateau). An ancillary study is also planned in this study with the hypothesise that : - Patients presenting post-operative delirium may exhibit significant perturbations of phenotypic and transcriptomic features of circulating leukocytes, of plasma levels of cytokines, and of oxidative stress level. - Administration of melatonin may prevent these perturbations. Ancillary study concerns Beaujon, Bichat and la Pitié centers.

    Phase

    3

    Span

    171 weeks

    Sponsor

    Assistance Publique - Hôpitaux de Paris

    Clichy-sous-Bois

    Recruiting

  • Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway

    Main objective: Describe the roles and missions of professionals dedicated to the coordination of care pathways for patients with HCC Secondary objectives: Compare the indicators of quality of care in HCC centres with a nurse coordinator: 1. Timeframe in treatment: - timeframe between the first contact with the HCC centre and the first interventional radiology treatment. - timeframe between the first contact with the centre and the first presentation at a multidisciplinary team meeting (MDT) - time between the first contact with the centre and the diagnostic consultation - timeframe between the first contact with the centre and discharge from the hospital - timeframe between the first interventional radiology procedure and the next for the subgroup of patients who have multiple procedures during the follow-up period - timeframe between the first contact with the nurse coordinator of the centre and discharge from the hospital. 2. The average length of stay of hospitalization 3. The number of visits to the emergency unit during the first month following the radiology intervention 4. The number of unscheduled readmissions during the first month following the intervention. Assess the feasibility of collecting the above-mentioned timeframe and variables and the patients and carers feedback on the coordination of the care pathway Describe the organization of care pathways for patients with HCC in centres with or without a nurse coordinator. Research method: This is a retrospective descriptive pilot study. It aims to describe the organization of care. Population: Patient with a diagnosis of localized hepatocellular carcinoma. Data processing: - Feasibility questionnaires will be sent by email. - The interviews will be transcribed and coded with NVivo® software - Patient data will be collected in the ecrf - Data processing from anonymized files by the authors of the research only. All data will be centralized at Bichat Hospital (URC Paris Nord) for statistical analysis.

    Phase

    N/A

    Span

    21 weeks

    Sponsor

    Assistance Publique - Hôpitaux de Paris

    Clichy-sous-Bois

    Recruiting

  • Study of the Impact of a Physical Activity Programme on the Quality of Life of Patients With Inflammatory Bowel Disease

    Crohn's disease and haemorrhagic rectocolitis are Chronic Inflammatory Bowel Diseases (CIBD) which evolve by flare-ups interspersed with periods of remission . The incidence of these two diseases is increasing in France in adults but also and especially in children and adolescents. Indeed, according to data from the EPIMAD registry, from 1988-1990 to 2009-2011, a significant increase in the incidence of both Crohn's disease and haemorrhagic rectocolitis was observed in adolescents (10-16 years): for Crohn's disease from 4.2 to 9.5/10 5 (+126%; P <0.001) and for UC from 1.6 to 4.1/10 5 (+156%; P <0.001). Over the long term, Crohn's disease can progress to intestinal destruction that can be complicated by stricture(s), obstruction(s), fistula(s) and/or abscesses leading to surgical treatment estimated at 50% after 10 years of Crohn's disease progression 1. Anti-TNFα therapies are widely prescribed for Crohn's disease because they control symptoms, heal the mucosa, reduce hospital admissions and improve quality of life. However, they are associated with side effects often reported by patients, such as asthenia, weight gain and joint pain, symptoms that could be improved by regular physical activity. Regular physical activity at a mild to moderate intensity can control inflammation in general and intestinal inflammation in particular during IBD. The effectiveness of a physical activity programme has been evaluated during IBD, but the data are limited to a few studies. Overall, PA improves quality of life but also improves control of disease symptoms and fatigue . The aim of the present work is to evaluate the impact of a physical activity programme on quality of life in patients with IBD. This programme will also evaluate the impact of physical activity on 1) anxiety-depression, 2) fatigue (a frequent and difficult to manage symptom in IBD), 3) IBD activity, 4) smoking cessation.

    Phase

    N/A

    Span

    141 weeks

    Sponsor

    Raincy Montfermeil Hospital Group

    Montfermeil

    Recruiting

  • Evaluation of the Impact of an Oral and Practical Presentation of Intrauterine Devices by a Health Professional on Women's Opinion as a Possible Contraceptive Method

    Contraception among women in France has evolved considerably and has become a frequent reason for consultation in general practice in view of the growing shortage of gynaecologists practising in towns. Intrauterine devices (IUDs) are the leading reversible contraceptive method used in the world, but only 20.7% of women in France were using them in 2010. In practice in France, the use of IUDs is still "reserved" for older women or those who have already had children, despite medical recommendations. Indeed, there is a certain feeling of mistrust towards the IUD as a contraceptive method. Sometimes the patient's reasons for refusal were unclear or misconceptions and prejudices prevailed. Various research studies and theses have identified the various obstacles to the use of the IUD as a contraceptive. Today it would be interesting to evaluate whether a short presentation of the IUD during a consultation would lead to a better acceptance of women to use it as a possible contraceptive method. In this study the investigators will investigate whether clear information about the mode of action and insertion/removal of IUDs would dispel these misconceptions of patients.

    Phase

    N/A

    Span

    29 weeks

    Sponsor

    Raincy Montfermeil Hospital Group

    Montfermeil

    Recruiting

  • Oxygen Therapy Remote Monitoring in COPD Patients.

    The observational study consists in collecting physiological data (cardiorespiratory and physical activity) and use of the oxygen therapy device in real life during the first months after the initiation of treatment. For this purpose, two connected medical devices will be provided to each patient during 2 periods of 2 weeks (weeks 6 to 8 then weeks 12 to 14 after the initiation of oxygen therapy). The devices are: 1/ a connected watch that continuously measures vital parameters (heart rate and blood oxygen saturation), and physical activity parameters (no. of steps, distance, duration of effort), and 2/ a Teleox device that remotely monitors patients equipped with an oxygen source (it measures the oxygen flow rate requested by the patient, the duration of use of the oxygen source, and the breathing rate). Study design: a cohort of 250 patients with COPD newly initiated a long term oxygen therapy will be enrolled in the study and follow-up over 6 months. Data will be collected by lung specialists and home health care provider teams at 2 months, 3.5 months and 6 months post-initiation of oxygen therapy.

    Phase

    N/A

    Span

    105 weeks

    Sponsor

    Vivisol

    Montfermeil

    Recruiting

  • SAPHIR : Assessment of Predictive Factors for Persistence of Treatment After Initiation of Adalimumab With a Biosimilar (Adalimumab Fresenius KaBI or Substitution of Reference Adalimumab With the Fresenius Kabi Adalimumab Biosimilar in Patients With Chronic Inflammatory Diseases

    In a population of adult patients who are targeted to initiate adalimumab or previously treated with Humira® to get switched to a biosimilar (FK adalimumab) and followed up for a period of 12 months under routine medical practice conditions. - Primary objective: to define predictive factors for the persistence of treatment - Secondary objectives: - To assess the therapeutic benefit and the tolerability of the treatment - To describe the reasons for treatment discontinuations occurring during follow-up

    Phase

    N/A

    Span

    162 weeks

    Sponsor

    Fresenius Kabi, France

    Montfermeil

    Recruiting

  • Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis

    TO FAst is a non-interventional study in France with primary objective to describe the clinical benefit of tofacitinib 1 year after its initiation for the treatment of moderate to severe UC in routine clinical practice. The study will also make it possible to report the clinical benefit 2 years after its initiation, to search for predictors of clinical benefit, improve our understanding of the efficacy of treatment in a real-life setting (in terms of response and speed of response), describe the characteristics of patients starting a treatment by tofacitinib, its real-life patterns of use as well as patient adherence to treatment.

    Phase

    N/A

    Span

    291 weeks

    Sponsor

    Pfizer

    Montfermeil

    Recruiting

  • Efficacy of Tocilizumab for the Treatment of Acute AION Related to GCA

    Tocilizumab will be proposed to eligible patients as an emergency treatment, in addition to the standard high-dose steroid treatment. Each patient will receive the reference treatment, i.e. one pulse of high dose intravenous methylprednisolone per day during 3 days, followed by 1 mg/kg/day oral prednisone, and low dose aspirin. Depending on the randomization, each patient will receive the reference treatment only, or will received in addition to the reference treatment four subcutaneous injections of tocilizumab 162 mg over one month (1 injection per week), the first tocilizumab injection being delivered on the same day than the first steroid IV pulse. Study visits will take place at 4, 8 and 13 weeks. The primary endpoint will be the ocular improvement at W8, defined as an increase of at least two lines of visual acuity on the ETRS chart. For each patient, the duration of participation will by of 3 months. The study duration is expected to be 15 months.

    Phase

    2

    Span

    118 weeks

    Sponsor

    Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

    Montfermeil

    Recruiting

  • A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab

    NUMBER OF PATIENTS : 238 patients in 20 sites in France RECRUITMENT PERIOD : The trial duration for each patient will be 144 weeks MAIN ENDPOINT : At week 48 success defined by: Endoscopic remission defined by an endoscopic Mayo score 0 SECONDARY ENDPOINTS: At W48 - Clinical remission (Clinical remission is defined as a total Mayo score ≤2 points, with no individual sub score >1, and a Mayo endoscopy sub score of 0 or 1) - Remission without steroids - Endoscopic healing rate with Mayo score 0 or 1 - UCEIS score - Histological healing (Nancy score) - Remission rate and remission rate without steroids at study visits and W48 - Quality of life evolution (evaluate visit W0 vs W14, W26, W38 and W48) - Patients satisfaction - Continuous response - Safety and tolerability - Anti-TNF pharmacokinetics - Number of visits in trial - Number of UC related hospitalizations - Number of colectomies - Treatment compliance (questionnaire) - Patient adhesion (questionnaire) - Medico-economic analysis

    Phase

    4

    Span

    438 weeks

    Sponsor

    Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    Montfermeil

    Recruiting

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