71 research outputs found

    A randomized trial of the efficacy and safety of sequential intravenous/oral moxifloxacin monotherapy versus intravenous piperacillin/tazobactam followed by oral amoxicillin/clavulanate for complicated skin and skin structure infections

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    Item does not contain fulltextOBJECTIVES: The primary aim of the RELIEF study was to evaluate the efficacy and safety of two sequential intravenous (iv)/oral regimens: moxifloxacin iv/oral versus piperacillin/tazobactam (TZP) iv followed by oral amoxicillin/clavulanate (AMC). PATIENTS AND METHODS: The study had a prospective, randomized, double-dummy, double-blind, multicentre design. Patients >/=18 years were prospectively stratified according to complicated skin and skin structure infection (cSSSI) subtype/diagnosis (major abscess, diabetic foot infection, wound infection or infected ischaemic ulcer), surgical intervention and severity of illness. Diagnoses and disease severity were based on predetermined criteria, documented by repeated photographs, and confirmed by an independent data review committee. Patients were randomized to receive either 400 mg of moxifloxacin iv once daily followed by 400 mg of moxifloxacin orally once daily or 4.0/0.5 g of TZP iv thrice daily followed by 875/125 mg of AMC orally twice daily for 7-21 days. The primary efficacy variable was clinical response at test of cure (TOC) for the per-protocol (PP) population. Clinical efficacy was assessed by the data review committee based on repeated photographs and case descriptions. Clinical trials registry number: NCT 00402727. RESULTS: A total of 813 patients were randomized. Clinical success rates at TOC were similar for moxifloxacin and TZP-AMC in the PP [320/361 (88.6%) versus 275/307 (89.6%), respectively; P = 0.758] and intent-to-treat (ITT) [350/426 (82.2%) versus 305/377 (80.9%), respectively; P = 0.632] populations. Thus, moxifloxacin was non-inferior to TZP-AMC. Bacteriological success rates were high in both treatment arms [moxifloxacin: 432/497 (86.9%) versus TZP-AMC: 370/429 (86.2%), microbiologically valid (MBV) population]. Moxifloxacin was non-inferior to TZP-AMC at TOC in both the MBV and the ITT populations. Both treatments were well tolerated. CONCLUSIONS: Once-daily iv/oral moxifloxacin monotherapy was clinically and bacteriologically non-inferior to iv TZP thrice daily followed by oral AMC twice daily in patients with cSSSIs

    The concordance between the volume hotspot and the grade hotspot: a 3-D reconstructive model using the pathology outputs from the PROMIS trial.

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    The rationale for directing targeted biopsy towards the centre of lesions has been questioned in light of prostate cancer grade heterogeneity. In this study, we assess the assumption that the maximum cancer Gleason grade (Gleason grade hotspot) lies within the maximum dimension (volume hotspot) of a prostate cancer lesion. 3-D histopathological models were reconstructed using the outputs of the 5-mm transperineal mapping (TPM) biopsies used as the reference test in the pilot phase of Prostate Mri Imaging Study (PROMIS), a paired validating cohort study investigating the performance of multi-parametric magnetic resonance imaging (MRI) against transrectal ultrasound (TRUS) biopsies. The prostate was fully sampled with 5 mm intervals; each core was separately labelled, inked and orientated in space to register 3-D cancer lesions location. The data from the histopathology results were used to create a 3-D interpolated reconstruction of each lesion and identify the spatial coordinates of the largest dimension (volume hot spot) and highest Gleason grade (Gleason grade hotspot) and assess their concordance. Ninety-four men, with median age 62 years (interquartile range, IQR= 58-68) and median PSA 6.5 ng ml(-1) (4.6-8.8), had a median of 80 (I69-89) cores each with a median of 4.5 positive cores (0-12). In the primary analysis, the prevalence of homogeneous lesions was 148 (76%; 95% confidence interval (CI) ±6.0%). In all, 184 (94±3.2%) lesions showed concordant hotspots and 11/47 (23±12.1%) of heterogeneous lesions showed discordant hotspots. The median 3-D distance between discordant hotspots was 12.8 mm (9.9-15.5). These figures remained stable on secondary analyses using alternative reconstructive assumptions. Limitations include a certain degree of error within reconstructed models. Guiding one biopsy needle to the maximum cancer diameter would lead to correct Gleason grade attribution in 94% of all lesions and 79% of heterogeneous ones if a true hit was obtained. Further correlation of histological lesions, their MRI appearance and the detectability of these hotspots on MRI will be undertaken once PROMIS results are released

    This Month in Investigative Urology

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    Spéciation des métaux Pb, Zn, Cd dans les poussières en suspension dans l'air ambiant par extractions chimiques et pae ESEM-EDS automatisé

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    To evaluate the toxicity, the biodisponibility and the environmental behaviour of metals like Pb, Zn , Cd in ambient air dust, it is necessary to determine the speciation of these elements, i.e their main physico-chemical species. A chemical extraction procedure has been defined and optimized for pure species of Pb, Zn and Cd (sulfate, sulphur, carbonate and oxide).Pour évaluer la toxicité, la biodisponibilité et le comportement dans l'environnement des métaux Pb, Zn et Cd, il est nécessaire de connaître leur spéciation, c'est à dire de déterminer leurs principales espèces physico-chimiques. Dans ce but, un protocole d'extractions chimiques a été défini et optimisé pour des espèces pures (sulfates, sulfures, carbonates et oxydes)

    Fast evolution of tropospheric Pb- and Zn-rich particles in the vicinity of a lead smelter

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    Dusts collected on air filters at a Pb–Zn refinery located in northern France were sampled in 1997, 1999 and 2002. The low temporal variability in major elements (Pb, Zn and S) abundances suggested chemical composition of particulate emissions was stable over time. In July 2001 and March 2002, atmospheric aerosols were sampled in the vicinity of the Pb–Zn refinery upwind and downwind from the smelters. Bulk concentrations of major elements (Al, Fe, Pb and Zn) and hydrosoluble ions (Na+, NH4+, Mg2+, K+, Ca2+, Cl– NO3– and SO42–) were, respectively, determined by atomic absorption spectrometry and ion chromatography. Elemental and molecular individual particle analyses were, respectively, performed by automated SEM–EDX and Raman microspectrometry. Continental air masses (campaign 2001) were characterized by low Na+ and high SO42–, NO3– and NH4+ contents upwind from the smelters. Individual particle analysis of Pb- and Zn-rich airborne particles collected downwind from the refinery indicated elemental associations and molecular speciation were similar to those obtained at the emission: Pb compounds were mainly identified as oxides, sulfates and oxy-sulfates whereas Zn compounds were identified as sulfides. Marine air masses (campaign 2002) were characterized by high Na+ contents upwind from the smelters. Individual particle analysis of Pb- and Zn-rich particles collected downwind from the refinery pointed out a systematic association with Na, not emitted by the refinery, suggesting internal mixing of marine aerosols with heavy-metals dusts emitted by the refinery. Such fast evolution of airborne particles chemical composition in the vicinity of the refinery was further proven by SEM–EDX and Raman microspectrometry mappings showing physical evolution by aggregation or coagulation of Zn- and Pb-rich particles with aged sea-salts
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