Putting in harm to cure: Drug related adverse events do not affect outcome of patients receiving treatment for multidrug-resistant Tuberculosis. Experience from a tertiary hospital in Italy.

RationaleTreatment of multi-drug resistant Tuberculosis (MDR-TB) is challenging because it mostly relies on drugs with lower efficacy and greater toxicity than those used for drug-susceptible TB.ObjectivesAim of the study was to describe the frequency and type of adverse drug reactions in a cohort of MDR-TB patients and their potential impact on treatment outcome.MethodsWe conducted a retrospective study in a cohort of MDR-TB patients enrolled at a tertiary referral hospital in Italy from January 2008 to December 2016. The records of patients were reviewed for epidemiological, clinical, microbiological and adverse drug reactions data.ResultsSeventy-four MDR-TB patients (mean age 32 years, 58.1% males, 2 XDR, 12 pre-XDR TB) were extracted from the Institute data base and included in the retrospective study cohort in the evaluation period (January 2008-December 2016). Median length of treatment duration was 20 months (IQR 14-24). Treatment outcome was successful in 57 patients (77%; 51 cured, 6 treatment completed); one patient died and one failed (2.7% overall); 15 patients were lost to follow-up (20.3%). Sixty-six (89.2%) presented adverse drug reactions during the whole treatment period. Total number of adverse drug reactions registered was 409. Three hundred forty-six (84.6%) were classified as adverse events (AEs) and 63 (15.4%) were serious AEs (SAEs). One third of the total adverse drug reactions (134/409; 32.8%) was of gastrointestinal origin, followed by 47/409 (11.5%) ototoxic drug reactions, thirty-five (8.6%) regarded central nervous system and 33 (8.1%) affected the liver. All 63 SAEs required treatment suspension with 61 SAEs out of 63 (96.8%) occurring during the first six months of treatment. Factors associated with unsuccessful treatment outcome were smoking (p = 0.039), alcohol abuse (p = 0.005) and homeless condition (p = 0.044). Neither the number of antitubercular drugs used in different combinations nor the number of AEs showed significant impact on outcome. Patients who completed the treatment experienced a greater number of AEs and SAEs (p ConclusionsOur data demonstrate that, despite the high frequency of adverse drug reactions and long term therapy, the clinical management of MDR-TB patients in a referral center could reach successful treatment according to WHO target, by implementing active and systematic clinical and laboratory assessment to detect, report and manage suspected and confirmed adverse drug reactions

National Institute for the Infectious Diseases “L. Spallanzani” IRCCS. Recommendations for COVID-19 Clinical Management

On January 9th, 2020, the “World Health Organization” (WHO) declared the identification, by Chinese Health authorities, of a novel coronavirus, further classified as SARS-CoV-2 responsible of a diseases (COVID-19) ranging from asymptomatic cases to severe respiratory involvement. On March 9th, 2020, WHO declared COVID-19 a global pandemic. Italy is the second most affected country by COVID-19 infection after China. The “L. Spallanzani” National Institute for the Infectious Diseases, IRCCS has been the first Italian hospital to admit and manage patients affected by COVID-19. Hereby, we show our recommendations for the management of COVID-19 patients, based on very limited clinical evidences; these recomendations should be considered as expert opinions, which may be modified according to newly produced literature data. *for the INMI COVID-19 Treatment Group – ICOTREG Abdeddaim A, Agrati C, Albarello F, Antinori A, Ascoli Bartoli T, Baldini F, Bellagamba R, Bevilacqua N, Bibas M, Biava G, Boumis E, Busso D, Camici M, Capobianchi MR, Capone A, Caravella I, Cataldo A, Cerilli S, Chinello G, Cicalini S, Corpolongo A, Cristofaro M, D’Abramo A, Dantimi C, De Angelis G, De Palo MG, D’Offizi G, De Zottis F, Di Lorenzo R, Di Stefano F, Fusetti M, Galati V, Gagliardini R, Garotto G, Gebremeskel Tekle Saba, Giancola ML, Giansante F, Girardi E, Goletti D, Granata G, Greci MC, Grilli E, Grisetti S, Gualano G, Iacomi F, Iannicelli G, Ippolito G, Lepore L, Libertone R, Lionetti R, Liuzzi G, Loiacono L, Macchione M, Marchioni L, Mariano A, Marini MC, Maritti M, Mastrobattista A, Mazzotta V, Mencarini P, Migliorisi-Ramazzini P, Mondi A, Montalbano M, Mosti S, Murachelli S, Musso M, Nicastri E, Noto P, Oliva A, Palazzolo C, Palmieri F, Pareo C, Petrone A, Pianura E, Pinnetti C, Pontarelli A, Puro V, Rianda A, Rosati S, Sampaolesi A, Santagata C, Scarcia D’Aprano S, Scarabello A, Schininà V, Scorzolini L, Stazi GV, Taibi C, Taglietti F, Tonnarini R, Topino S, Vergori A, Vincenzi L, Visco-Comandini U, Vittozzi P, Zaccarelli M, Zaccaro G