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.
Effectiveness and safety of meropenem/ clavulanate-containing regimens in the treatment of MDR- and XDR-TB / Tiberi, Simon; Payen, Marie Christine; Sotgiu, Giovanni; D'Ambrosio, Lia; Guizado, Valentina Alarcon; Alffenaar, Jan Willem; Arbex, Marcos Abdo; Caminero, Jose A.; Centis, Rosella; De Lorenzo, Saverio; Gaga, Mina; Gualano, Gina; Arias, Aurora Jazmín Roby; Scardigli, Anna; Skrahina, Alena; Solovic, Ivan; Sulis, Giorgia; Tadolini, Marina; Akkerman, Onno W.; Arrascue, Edith Alarcon; Aleska, Alena; Avchinko, Vera; Bonini, Eduardo Henrique; Marín, Félix Antonio Chong; López, Lorena Collahuazo; De Vries, Gerard; Dore, Simone; Kunst, Heinke; Matteelli, Alberto; Moschos, Charalampos; Palmieri, Fabrizio; Papavasileiou, Apostolos; Spanevello, Antonio; Vasquez, Dante Vargas; Viggiani, Pietro; White, Veronica; Zumla, Alimuddin; Migliori, Giovanni Battista. - In: EUROPEAN RESPIRATORY JOURNAL. - ISSN 0903-1936. - ELETTRONICO. - 47:4(2016), pp. 1235-1243. [10.1183/13993003.02146-2015]
Effectiveness and safety of meropenem/ clavulanate-containing regimens in the treatment of MDR- and XDR-TB
TADOLINI, MARINA;
2016
Abstract
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
