Tebe, C. (C.)
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- EUS-guided tissue acquisition in the study of the adrenal glands: Results of a nationwide multicenter study(Public Library of Science (PLoS), 2019) Barturen-Barroso, A. (A.); Tebe, C. (C.); Lozano, M.D. (María Dolores); Sánchez-Yague, A. (A.); Iglesia, D. (D.) de la; García-Guix, M. (M.); Subtil, J.C. (José Carlos); Fernández-Esparrach, G. (G.); Vázquez-Sequeiros, E. (E.); Martín-Cardona, A. (A.); Morales-Alvarado, V.J. (V. J.); Sánchez-Montes, C. (C.); Velasco-Guardado, A. (A.); Castellot, A. (A.); Huertas, C. (C.); Gimeno-García, A.Z. (A. Z.); Pardo-Balteiro, A. (A.); Loras, C. (C.); Terán, A. (A.); Gines, A. (A.); Gornals, J.B. (J. B.); Esteban, J.M. (J. M.); Lariño-Noia, J. (J.); Martinez-Moreno, B. (B.); Martínez-Lapiedra, M. (M.); Spanish Group for EUS-Guided TA in the adrenal gland; Betes, M.T. (María Teresa); Iglesias-García, J. (J.)Background: There are limited data about the role of endoscopic ultrasound-guided tissue acquisition (EUS-TA), by fine needle aspiration (EUS-FNA) or biopsy (EUS-FNB), in the evaluation of the adrenal glands (AG). The primary aim was to assess the diagnostic yield and safety. The secondary aims were the malignancy predictors, and to create a predictive model of malignancy. Methods: This was a retrospective nationwide study involving all Spanish hospitals experienced in EUS-TA of AGs. Inclusion period was from April-2003 to April-2016. Inclusion criteria: all consecutive cases that underwent EUS-TA of AGs. EUS and cytopathology findings were evaluated. Statistical analyses: diagnostic accuracy of echoendoscopist's suspicion using cytology by EUS-TA, as gold standard; multivariate logistic regression model to predict tumor malignancy. Results: A total of 204 EUS-TA of AGs were evaluated. Primary tumor locations were lung70%, others19%, and unknown11%. AG samples were adequate for cytological diagnosis in 91%, and confirmed malignancy in 60%. Diagnostic accuracy of the endosonographer's suspicion was 68%. The most common technique was: a 22-G (65%) and cytological needle (75%) with suction-syringe (66%). No serious adverse events were described. The variables most associated with malignancy were size>30mm (OR2.27; 95%CI, 1.16-4.05), heterogeneous echo-pattern (OR2.11; 95%CI, 1.1-3.9), variegated AG shape (OR2.46; 95%CI, 1-6.24), and endosonographer suspicion (OR17.46; 95%CI, 6.2-58.5). The best variables for a predictive multivariate logistic model of malignancy were age, sex, echo-pattern, and AG-shape. Conclusions: EUS-TA of the AGs is a safe, minimally invasive procedure, allowing an excellent diagnostic yield. These results suggest the possibility of developing a pre-EUS procedure predictive malignancy model.
- Efficacy of extended infusion of β-lactam antibiotics for the treatment of febrile neutropenia in haematologic patients: protocol for a randomised, multicentre, open-label, superiority clinical trial (BEATLE)(2020) Garcia-Vidal, C. (C.); Arnan, M. (M.); Tebe, C. (C.); Padullés, A. (A.); Puerta-Alcalde, P. (Pedro); NO USAR del-Pozo, J.L. (José Luis); Parody, R. (Rocío); Carmona-Torre, F. (Francisco de A.); Videla, S. (S.); Muñoz, C. (C.); Laporte-Amargos, J. (J.); Tubau, F. (F.); Huguet, M. (M.); Rigo-Bonnin, R. (R.); Carratalà, J. (Jordi); Batlle, M. (M.); Gudiol, C. (Carlota); Sureda-Balari, A. M. (Anna Maria); Albasanz-Puig, A. (Adaia)Background: Febrile neutropaenia (FN) is a very common complication in patients with haematological malignancies and is associated with considerable morbidity and mortality. Broad-spectrum antipseudomonal βlactam antibiotics (BLA) are routinely used for the treatment of cancer patients with FN. However, the clinical efficacy of BLA may be diminished in these patients because they present with pathophysiological variations that compromise the pharmacokinetic (PK) parameters of these antibiotics. Optimised administration of BLA in prolonged infusions has demonstrated better clinical outcomes in critically ill patients. However, there is a paucity of data on the usefulness of this strategy in patients with FN. The aim of this study is to test the hypothesis that the administration of BLA would be clinically more effective by extended infusion (EI) than by intermittent infusion (II) in haematological patients with FN. Methods: A randomised, multicentre, open-label, superiority clinical trial will be performed. Patients with haematological malignancies undergoing chemotherapy or haematopoietic stem-cell transplant and who have FN and receive empirical antibiotic therapy with cefepime, piperacillin-tazobactam or meropenem will be randomised (1:1) to receive the antibiotic by EI (during half the time of the dosing interval) in the study group, or by II (30 min) in the control group. The primary endpoint will be clinical efficacy, defined as defervescence without modifying the antibiotic treatment administered within the first 5 days of therapy. The primary endpoint will be analysed in the intention-to-treat population. The secondary endpoints will be pharmacokinetic/pharmacodynamic (PK/PD) target achievement, bacteraemia clearance, decrease in C-reactive protein, overall (30-day) case-fatality rate, adverse events and development of a population PK model of the BLA studied. Discussion: Data on the usefulness of BLA administration in patients with FN are scant. Only three clinical studies addressing this issue have been published thus far, with contradictory results. Moreover, these studies had some methodological flaws that limit the interpretation of their findings. If this randomised, multicentre, phase IV, open-label, superiority clinical trial validates the hypothesis that the administration of BLA is clinically more effective by EI than by II in haematological patients with FN, then the daily routine management of these high-risk patients could be changed to improve their outcomes. Trial registration: European Clinical Trials Database: EudraCT 2018–001476-37. ClinicalTrials.gov, ID: NCT04233996.
- Impact of antibiotic resistance on outcomes of neutropenic cancer patients with Pseudomonas aeruginosa bacteraemia (IRONIC study): study protocol of a retrospective multicentre international study(BMJ, 2019) Tebe, C. (C.); Isler, B. (Burcu); Manzur, A. (Adriana); Ibrahim, K. (Karim); Montero, M. (Milagros); Kern, W. (Winfried); Calik, S. (Sebnem); Yáñez, L. (Lucrecia); Herrera, F. (Fabián); Hemmati, P. (Philipp); Márquez-Gómez, I. (Ignacio); Puerta-Alcalde, P. (Pedro); Brunel, A.S. (Anne Sophie); Ribeiro, M. (Marisa); Drgona, L. (Lubos); Kanj, S. (Souha); Parody, R. (Rocío); Pozo, J.L. (José Luis) del; Montejo, J.M. (José Miguel); Akova, M. (Murat); Maestro-de-la-Calle, G. (Guillermo); Oltolini, C. (Chiara); Morales, I. (Isabel); Marin, J.I. (Jorge Iván); Tilley, R. (Robert); Martín-Dávila, P. (Pilar); Ruiz-Camps, I. (Isabel); Carratalà, J. (Jordi); Araos, R. (Rafael); Gudiol, C. (Carlota); García, E. (Estefania); Peghin, M. (Maddalena); Mikulska, M. (Malgorzata); Paz-Morales, H.M. (Hugo Manuel); Novo, A. (Andrés); Sipahi, O. (Oguz); Albasanz-Puig, A. (Adaia)Introduction: Pseudomonas aeruginosa (PA) has historically been one of the major causes of severe sepsis and death among neutropenic cancer patients. There has been a recent increase of multidrug-resistant PA (MDRPA) isolates that may determine a worse prognosis, particularly in immunosuppressed patients. The aim of this study is to establish the impact of antibiotic resistance on the outcome of neutropenic onco-haematological patients with PA bacteraemia, and to identify the risk factors for MDRPA bacteraemia and mortality. Methods and analysis: This is a retrospective, observational, multicentre, international study. All episodes of PA bacteraemia occurring in neutropenic oncohaematological patients followed up at the participating centres from 1 January 2006 to 31 May 2018 will be retrospectively reviewed. The primary end point will be overall case-fatality rate within 30 days of onset of PA bacteraemia. The secondary end points will be to describe the following: the incidence and risk factors for multidrugresistant and extremely drug-resistant PA bacteraemia (by comparing the episodes due to susceptible PA with those produced by MDRPA), the efficacy of ceftolozane/ tazobactam, the rates of persistent bacteraemia and bacteraemia relapse and the risk factors for very early (48 hours), early (7 days) and overall (30 days) case-fatality rates. Ethics and dissemination: The Clinical Research Ethics Committee of Bellvitge University Hospital approved the protocol of the study at the primary site. To protect personal privacy, identifying information of each patient in the electronic database will be encrypted. The processing of the patients’ personal data collected in the study will comply with the Spanish Data Protection Act of 1998 and with the European Directive on the privacy of data. All data collected, stored and processed will be anonymised. Results will be reported at conferences and in peerreviewed publications.