PT - JOURNAL ARTICLE AU - Simon Tiberi AU - Marie-Christine Payen AU - Giovanni Sotgiu AU - Lia D'Ambrosio AU - Valentina Alarcon Guizado AU - Jan Willem Alffenaar AU - Marcos Abdo Arbex AU - Jose A. Caminero AU - Rosella Centis AU - Saverio De Lorenzo AU - Mina Gaga AU - Gina Gualano AU - Aurora Jazmín Roby Arias AU - Anna Scardigli AU - Alena Skrahina AU - Ivan Solovic AU - Giorgia Sulis AU - Marina Tadolini AU - Onno W. Akkerman AU - Edith Alarcon Arrascue AU - Alena Aleska AU - Vera Avchinko AU - Eduardo Henrique Bonini AU - Félix Antonio Chong Marín AU - Lorena Collahuazo López AU - Gerard de Vries AU - Simone Dore AU - Heinke Kunst AU - Alberto Matteelli AU - Charalampos Moschos AU - Fabrizio Palmieri AU - Apostolos Papavasileiou AU - Antonio Spanevello AU - Dante Vargas Vasquez AU - Pietro Viggiani AU - Veronica White AU - Alimuddin Zumla AU - Giovanni Battista Migliori TI - Effectiveness and safety of meropenem/clavulanate-containing regimens in the treatment of MDR- and XDR-TB AID - 10.1183/13993003.02146-2015 DP - 2016 Apr 01 TA - European Respiratory Journal PG - 1235--1243 VI - 47 IP - 4 4099 - http://erj.ersjournals.com/content/47/4/1235.short 4100 - http://erj.ersjournals.com/content/47/4/1235.full SO - Eur Respir J2016 Apr 01; 47 AB - No large study has ever evaluated the efficacy, safety and tolerability of meropenem/clavulanate to treat multidrug- and extensively drug-resistant tuberculosis (MDR- and XDR-TB). The aim of this observational study was to evaluate the therapeutic contribution, effectiveness, safety and tolerability profile of meropenem/clavulanate added to a background regimen when treating MDR- and XDR-TB cases.Patients treated with a meropenem/clavulanate-containing regimen (n=96) showed a greater drug resistance profile than those exposed to a meropenem/clavulanate-sparing regimen (n=168): in the former group XDR-TB was more frequent (49% versus 6.0%, p<0.0001) and the median (interquartile range (IQR)) number of antibiotic resistances was higher (8 (6–9) versus 5 (4–6)). Patients were treated with a meropenem/clavulanate-containing regimen for a median (IQR) of 85 (49–156) days.No statistically significant differences were observed in the overall MDR-TB cohort and in the subgroups with and without the XDR-TB patients; in particular, sputum smear and culture conversion rates were similar in XDR-TB patients exposed to meropenem/clavulanate-containing regimens (88.0% versus 100.0%, p=1.00 and 88.0% versus 100.0%, p=1.00, respectively). Only six cases reported adverse events attributable to meropenem/clavulanate (four of them then restarting treatment).The nondifferent outcomes and bacteriological conversion rate observed in cases who were more severe than controls might imply that meropenem/clavulanate could be active in treating MDR- and XDR-TB cases.Meropenem/clavulanate is effective and safe to treat MDR- and XDR-TB in comparison with controls http://ow.ly/XG75j