Causes and MEchanisms foR non-atopic Asthma in Children (CAMERA) study: rationale and protocol

BACKGROUND: The Causes And MEchanisms foR non-atopic Asthma in children (CAMERA) study was designed to investigate risk factors and mechanisms of non-atopic asthma in children and young adults in Brazil, Ecuador, Uganda, and New Zealand. Initial epidemiological analyses using existing datasets identified and compared risk factors for both atopic and non-atopic asthma. The focus of this paper is the protocol for sample collection and analysis of clinical data on possible non-atopic mechanisms. METHODS: In each of the four centres, the CAMERA study will enroll 160 participants aged 10-28 years, equally distributed among atopic asthmatics (AA), non-atopic asthmatics (NAA), atopic non-asthmatics and non-atopic non-asthmatics. Participants will be new recruits or returning World ASthma Phenotypes (WASP) study participants. Phase I consists of skin prick tests to define atopy, a general CAMERA questionnaire that covers respiratory and general health to identify asthma cases, followed by an asthma control questionnaire for asthmatics only. Phase II consists of a stress questionnaire and the following clinical assessments: lung function, nasal cytology, blood sampling, in vitro whole blood stimulation to assess IFN-γ production, hair cortisol concentration, dry air and capsaicin challenges, plus in a subset, cold air challenges. Analyses will compare inflammatory, physiological and clinical parameters across the four groups overall and by country. DISCUSSION: Here, we present the protocol for the CAMERA study, to provide relevant methodological details for CAMERA publications and to allow other centres globally to conduct similar analyses. The findings of this mechanistic multi-centre study will inform new and phenotype-specific prevention and treatment approaches. CLINICAL TRIAL NUMBER: Not applicable.fals

Causes and MEchanisms foR non-atopic Asthma in Children (CAMERA) study: rationale and protocol

Abstract Background The Causes And MEchanisms foR non-atopic Asthma in children (CAMERA) study was designed to investigate risk factors and mechanisms of non-atopic asthma in children and young adults in Brazil, Ecuador, Uganda, and New Zealand. Initial epidemiological analyses using existing datasets identified and compared risk factors for both atopic and non-atopic asthma. The focus of this paper is the protocol for sample collection and analysis of clinical data on possible non-atopic mechanisms. Methods In each of the four centres, the CAMERA study will enroll 160 participants aged 10–28 years, equally distributed among atopic asthmatics (AA), non-atopic asthmatics (NAA), atopic non-asthmatics and non-atopic non-asthmatics. Participants will be new recruits or returning World ASthma Phenotypes (WASP) study participants. Phase I consists of skin prick tests to define atopy, a general CAMERA questionnaire that covers respiratory and general health to identify asthma cases, followed by an asthma control questionnaire for asthmatics only. Phase II consists of a stress questionnaire and the following clinical assessments: lung function, nasal cytology, blood sampling, in vitro whole blood stimulation to assess IFN-γ production, hair cortisol concentration, dry air and capsaicin challenges, plus in a subset, cold air challenges. Analyses will compare inflammatory, physiological and clinical parameters across the four groups overall and by country. Discussion Here, we present the protocol for the CAMERA study, to provide relevant methodological details for CAMERA publications and to allow other centres globally to conduct similar analyses. The findings of this mechanistic multi-centre study will inform new and phenotype-specific prevention and treatment approaches. Clinical trial number Not applicable

The regression between multiple inflammatory markers and C-IMT in normocholesterolemic stable IHD. The effect of moderate dose of atorvastatina (MIAMI study)

Introduction: Plasma levels of Hs-CRP may be useful to select subjects at high risk of cardiovascular events. This inflammatory marker also helps identify patients most likely to respond to statins. Aim: A prospective clinical study was designed to investigate in a population of stable IHD patients treated with Atorvastatin: a) the regression of CRP levels and other soluble inflammatory" markers; b) the correlations between levels of Carotid Intima Media Thickness (C-IMT) and a series of soluble markers at different times; c) the influence of Hs-CRP levels on C-IMT regression; d) the utility of C-IMT as an additional marker to identify patients likely to respond to statins. Materials and Methods: MIAMI is an open, multicenter, independent study. In 100 patients with previous MI (> two months), in stable clinical conditions, with normal cholesterol and blood glucose, receiving atorvastatin (20 mg/daily) for 24 months, the following variables were measured at 0, 12 and 24 month: VCAM, ICAM, E-selectins, IL-6, -8, -10, -18, TNF-alpha, hs-CRP, MMP-9, TF, TFPI, Fg, TC, HDL, LDL, TG, urinary isoprostanes. C-IMT was measured blindly by computerised determination of images recorded in three examinations. The study started in January 2003 and is scheduled to end in December 2005. Topic Preferences: 1) New Markers for Cardiovascular Risk (18.) 2) Inflammation and Atherosclerosis (21.) 3) Pleiotropic effects of Lipid Lowering Drugs (41.

Combination of Vancomycin and β-Lactam Therapy for Methicillin-Resistant Staphylococcus aureus Bacteremia: A Pilot Multicenter Randomized Controlled Trial

BACKGROUND: In vitro laboratory and animal studies demonstrate a synergistic role for the combination of vancomycin and antistaphylococcal β-lactams for methicillin-resistant Staphylococcus aureus (MRSA) bacteremia. Prospective clinical data are lacking. METHODS: In this open-label, multicenter, clinical trial, adults with MRSA bacteremia received vancomycin 1.5 g intravenously twice daily and were randomly assigned (1:1) to receive intravenous flucloxacillin 2 g every 6 hours for 7 days (combination group) or no additional therapy (standard therapy group). Participants were stratified by hospital and randomized in permuted blocks of variable size. Randomization codes were kept in sealed, sequentially numbered, opaque envelopes. The primary outcome was the duration of MRSA bacteremia in days. RESULTS: We randomly assigned 60 patients to receive vancomycin (n = 29), or vancomycin plus flucloxacillin (n = 31). The mean duration of bacteremia was 3.00 days in the standard therapy group and 1.94 days in the combination group. According to a negative binomial model, the mean time to resolution of bacteremia in the combination group was 65% (95% confidence interval, 41%-102%; P = .06) that in the standard therapy group. There was no difference in the secondary end points of 28- and 90-day mortality, metastatic infection, nephrotoxicity, or hepatotoxicity. CONCLUSIONS: Combining an antistaphylococcal β-lactam with vancomycin may shorten the duration of MRSA bacteremia. Further trials with a larger sample size and objective clinically relevant end points are warranted.Full Tex