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Rodriguez de la Pinta M.L.,Hospital Universitario Puerta Of Hierro | Castro Lareo M.I.,Complejo Hospitalario Universitario | Ramon Torrell J.M.,IDIBELL | Garcia de Lomas J.,Instituto Valenciano Of Microbiologia | And 5 more authors.

Introduction: This multi-center, hospital-based observational study determined the seroprevalence of pertussis antibodies amongst healthcare professionals from three different hospitals in Spain to ascertain the health status of professionals attending to susceptible groups who are at risk of contracting and transmitting pertussis. Methods: Medical professionals from three hospitals in Spain were recruited for this study (NCT01706224). Serum samples from subjects were assessed for anti-pertussis antibodies by ELISA. The percentage of subjects positive for anti-pertussis antibodies were determined by age-strata, gender, vaccination status, professional level (physicians, nurses, ancillary nurses and midwives), hospital department, number of working years, numbers of hours spent with the patient as well as number of children in the household. Results: Overall, 31.2% of subjects were seropositive; 3.3% of these healthcare professionals had ELISA values indicative of current or recent infection. There were no significant differences in terms of pertussis prevalence with respect to age, gender, hospital department, profession, number of working years and number of hours spent with patients. These levels of seronegativity amongst healthcare workers further strengthen the rationale for vaccination amongst this specific population against pertussis. © 2016. Source

Melilli E.,University of Barcelona | Crespo E.,IDIBELL | Sandoval D.,University of Barcelona | Manonelles A.,University of Barcelona | And 6 more authors.
Transplant International

The use of generic formulations of immunosuppressive drugs in renal transplantation has been and still is a controversial subject. The lack of clinical studies about safety and efficacy in transplant patients is one of the factors restricting the diffusion of generic drugs in the renal transplant field. Since March 2013, our transplant unit has incorporated generic tacrolimus (Adoport®; Sandoz), replacing the one we were currently using (Prograf®; Astellas). When carrying out our retrospective analysis comparing the two different formulations, we evaluated several clinical results: tacrolimus trough concentrations (C0) at 5-7 days; 1, 3, and 6 months post-transplantation; concentration/dose ratio at 6 months; acute rejection incidence; delayed graft function (DGF); renal function (as CKD-EPI); and proteinuria at 6 months in 120 patients (1:1 ratio of Prograf® versus Adoport®), noticing no important differences. We also evaluated the results of protocol biopsies at 6 months in a subgroup of patients, thus verifying the safety and efficacy of this particular generic drug versus the reference product on a histological basis as well. No difference in the development of dnDSA (de novo donor-specific antibody) was found between the two groups. © 2015 Steunstichting ESOT. Source

Balbuena J.,University of Navarra | Pachon G.,Vall dHebron Research Institute | Lopez-Torrents G.,Vall dHebron Research Institute | Aran J.M.,IDIBELL | And 2 more authors.
Cytometry Part A

The Sonic Hedgehog (Hh) pathway has been implicated in the maintenance of stem or progenitor cells in many adult tissues. Importantly, abnormal Hh pathway activation is also associated with initiation of neoplasia, but its role in tumor growth is still unclear. Here, we demonstrate that cyclopamine, a plant-derived alkaloid product used to inhibit the Hh signaling pathway, reduces the Side Population (SP) obtained by Hoechst 33342 (Ho342) dye measurements. In addition, cyclopamine is able to modulate, along with oxysterols and other products, the ABCG2 transporter by increasing Ho342 and mitoxantrone uptake. Therefore, if the SP is solely measured as a Ho342 dye extruding fraction, this may be significantly modulated by the inhibition of ABCG2 transport fraction, independently from the action of cyclopamine on the Hh pathway. Our results indicate that ABCG2 may act in the upstream regulation of the Hh signaling pathway to protect the stemness of the SP compartment, giving support to the cancer stem cell hypothesis and suggesting that ABCG2 is not only critical for increased resistance to anticancer agents. © 2011 International Society for Advancement of Cytometry. Source

Padulles Caldes A.,IDIBELL | Colom H.,University of Barcelona | Caldes A.,IDIBELL | Cerezo G.,IDIBELL | And 3 more authors.
Therapeutic Drug Monitoring

BACKGROUND: Ganciclovir and valganciclovir (GCV/VGCV) are used for the treatment and prophylaxis of cytomegalovirus in solid organ transplant (SOT) patients. An area under the time-concentration curve of 40-50 μg × h/mL is related to efficacy. Therapeutic drug monitoring could prevent suboptimal drug exposure and adverse events, but obtaining full concentration profiles is not feasible. Sampling optimization by developing a reliable and clinically applicable limited sampling strategy (LSS) may simplify dose adjustment. METHODS: An LSS was developed using an original pharmacokinetic (PK) data set of 40 full profiles from 20 adult SOT patients. The LSS was developed based on population and Bayesian prediction approaches. Population PK parameters from a previous model were used for simulation or as priors (NONMEM version 7.2). Median percentage of prediction error and median of absolute percentage prediction error were calculated for plasma clearance (CL) and central compartment distribution volume (V2). Bias and precisions were compared using 1-way analysis of variance (SPSSv19.0). RESULTS: Sampling windows were designed according to the PK profile previously observed with the entire set of data. The 4 windows selected were distributed from 0.5 to 1.5 hours, 2 to 3 hours, 4 to 5 hours, and 6 to 8 hours. Predose and concentrations beyond 8 hours were not considered in any case because simulated negative concentrations occurred in both cases. Predicted exposure using 3 sampling times (0.5-1.5, 4-5, and 6-8 hours) showed the best predictive performance, by either the population or Bayesian approaches. Bias and imprecision for CL and V2 were 0 and 0.60%, and -0.78% and 0.78%, respectively. CONCLUSIONS: GCV/VCG area under the time-concentration curve in SOT patients could be predicted with acceptable accuracy for clinical management and dose individualization using LSS. The estimator of GCV/VGC, using 3 concentrations measured at 0.5-1.5, 4-5, and 6-8 hours after drug intake, could be used for dose adjustment. © 2014 by Lippincott Williams & Wilkins. Source

Bestard O.,University of Barcelona | Crespo E.,IDIBELL | Stein M.,Berlin Brandenburg Center for Regenerative Therapies | Stein M.,Charite - Medical University of Berlin | And 13 more authors.
American Journal of Transplantation

Assessment of donor-specific alloreactive memory/effector T cell responses using an IFN-γ Elispot assay has been suggested to be a novel immune-monitoring tool for evaluating the cellular immune risk in renal transplantation. Here, we report the cross-validation data of the IFN-γ Elispot assay performed within different European laboratories taking part of the EU RISET consortium. For this purpose, development of a standard operating procedure (SOP), comparisons of lectures of IFN-γ plates assessing intra- and interlaboratory assay variability of allogeneic or peptide stimuli in both healthy and kidney transplant individuals have been the main objectives. We show that the use of a same SOP and count-settings of the Elispot bioreader allow low coefficient variation between laboratories. Frozen and shipped samples display slightly lower detectable IFN-γ frequencies than fresh samples. Importantly, a close correlation between different laboratories is obtained when measuring high frequencies of antigen-specific primed/memory T cell alloresponses. Interestingly, significant high donor-specific alloreactive T cell responses can be similarly detected among different laboratories in kidney transplant patients displaying histological patterns of acute T cell mediated rejection. In conclusion, assessment of circulating alloreactive memory/effector T cells using an INF-γ Elispot assay can be accurately achieved using the same SOP, Elispot bioreader and experienced technicians in kidney transplantation. © Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons. Source

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