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    Comparative Evaluation of In Vitro Activities of Carbapenemes Against Gram-Negative Pathogens: Turkish Data of COMPACT Study
    (Ankara Microbiology Soc, 2011) Korten, Volkan; Soyletir, Guner; Yalcin, Ata Nevzat; Ogunc, Dilara; Dokuzoguz, Basak; Esener, Harika; Ulusoy, Sercan; Tunger, Alper; Aygen, Bilgehan; Sumerkan, Bulent; Arman, Dilek; Dizbay, Murat; Akova, Murat; Hascelik, Gulsen; Eraksoy, Haluk; Basaran, Seniha; Koksal, Iftihar; Bayramoglu, Gulcin; Akalin, Halis; Sinirtas, Melda
    The aim of this study was to determine the in vitro activities of doripenem, imipenem, and meropenem against clinical gram-negative isolates. A total of 596 clinical isolates were obtained from intensive care unit (ICU) and non-ICU patients in 10 centers over Turkey between September-December 2008. The origin of the isolates was patients with nosocomial pneumonia (42.4%), bloodstream infections (%40.4), and complicated intraabdominal infections (17.1%). Of the isolates, 51.8% were obtained from ICU patients. The study isolates consisted of Pseudomonas spp. in 49.8%, Enterobacteriaceae in 40.3%, and other gram-negative agents in 9.9%. The minimum inhibitory concentrations (MIC) for doripenem, imipenem and meropenem were determined for all isolates in each center using Etest (R) strips (AB Biodisk, Solna, Sweden). Of the isolates, 188 (31.5%) were resistant to at least one of the carbapenems. MIC(50) of doripenem against Pseudomonas spp. was 1 mg/L which was similar to that of meropenem and two-fold lower than imipenem. Susceptibility to carbapenems in P.aeruginosa was 64% for doripenem at an MIC level of 2 mg/L, 53.9% and 63% for imipenem and meropenem at an MIC level of 4 mg/L, respectively. Doripenem and meropenem showed similar activity with the MIC(90) of 0.12 mg/L whereas imipenem was four-fold less active at 0.5 mg/L. Against other gram-negative pathogens, mostly Acinetobacter spp., MIC(50) was 8 mg/L for doripenem and 32 mg/L for other two carbapenems. P.aeruginosa isolates were inhibited 84.2% with doripenem and 72.1% with meropenem at the MIC level of 8 mg/L. Doripenem generally showed similar or slightly better activity than meropenem and better activity than imipenem against pathogens collected in this study. Against Pseudomonas spp., doripenem was the most active of the three carbapenems. Doripenem and meropenem were equally active against Enterobacteriaceae and at least four-fold more active than imipenem. It was concluded that doripenem seemed to be a promising agent in the treatment of nosocomial pneumonia, blood stream infections and intraabdominal infections particularly in patients who were under risk of developing antimicrobial resistance.
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    Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey
    (Elsevier Science Inc, 2021) Tanriover, Mine Durusu; Doganay, Hamdi Levent; Akova, Murat; Guner, Hatice Rahmet; Azap, Alpay; Akhan, Sila; Kose, Sukran
    Background CoronaVac, an inactivated whole-virion SARS-CoV-2 vaccine, has been shown to be well tolerated with a good safety profile in individuals aged 18 years and older in phase 1/2 trials, and provided a good humoral response against SARS-CoV-2. We present the interim efficacy and safety results of a phase 3 clinical trial of CoronaVac in Turkey. Methods This was a double-blind, randomised, placebo-controlled phase 3 trial. Volunteers aged 18-59 years with no history of COVID-19 and with negative PCR and antibody test results for SARS-CoV-2 were enrolled at 24 centres in Turkey. Exclusion criteria included (but were not limited to) immunosuppressive therapy (including steroids) within the past 6 months, bleeding disorders, asplenia, and receipt of any blood products or immunoglobulins within the past 3 months. The K1 cohort consisted of health-care workers (randomised in a 1:1 ratio), and individuals other than health-care workers were also recruited into the K2 cohort (randomised in a 2:1 ratio) using an interactive web response system. The study vaccine was 3 mu g inactivated SARS-CoV-2 virion adsorbed to aluminium hydroxide in a 0.5 mL aqueous suspension. Participants received either vaccine or placebo (consisting of all vaccine components except inactivated virus) intramuscularly on days 0 and 14. The primary efficacy outcome was the prevention of PCR-confirmed symptomatic COVID-19 at least 14 days after the second dose in the per protocol population. Safety analyses were done in the intention-to-treat population. This study is registered with ClinicalTrials.gov (NCT04582344) and is active but no longer recruiting. Findings Among 11 303 volunteers screened between Sept 14, 2020, and Jan 5, 2021, 10 218 were randomly allocated. After exclusion of four participants from the vaccine group because of protocol deviations, the intention-to-treat group consisted of 10 214 participants (6646 [65.1%] in the vaccine group and 3568 [34.9%] in the placebo group) and the per protocol group consisted of 10 029 participants (6559 [65.4%] and 3470 [34.6%]) who received two doses of vaccine or placebo. During a median follow-up period of 43 days (IQR 36-48), nine cases of PCR-confirmed symptomatic COVID-19 were reported in the vaccine group (31.7 cases [14.6-59.3] per 1000 person-years) and 32 cases were reported in the placebo group (192.3 cases [135.7-261.1] per 1000 person-years) 14 days or more after the second dose, yielding a vaccine efficacy of 83.5% (95% CI 65.4-92.1; p<0.0001). The frequencies of any adverse events were 1259 (18.9%) in the vaccine group and 603 (16.9%) in the placebo group (p=0.0108) with no fatalities or grade 4 adverse events. The most common systemic adverse event was fatigue (546 [8.2%] participants in the vaccine group and 248 [7.0%] the placebo group, p=0.0228). Injection-site pain was the most frequent local adverse event (157 [2.4%] in the vaccine group and 40 [1.1%] in the placebo group, p<0.0001). Interpretation CoronaVac has high efficacy against PCR-confirmed symptomatic COVID-19 with a good safety and tolerability profile. Copyright (C) 2021 Elsevier Ltd. All rights reserved.
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    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 Publishing Group, 2019) Albasanz-Puig, Adaia; Gudiol, Carlota; Parody, Rocio; Tebe, Cristian; Akova, Murat; Araos, Rafael; Bote, Anna; Brunel, Anne-Sophie; Calik, Sebnem; Drgona, Lubos; Garcia, Estefania; Hemmati, Philipp; Herrera, Fabian; Ibrahim, Karim Yaqub; Isler, Burcu; Kanj, Souha; Kern, Winfried; Maestro de la Calle, Guillermo; Manzur, Adriana; Ivan Marin, Jorge; Marquez-Gomez, Ignacio; Martin-Davila, Pilar; Mikulska, Malgorzata; Montejo, Jose Miguel; Montero, Milagros; Paz Morales, Hugo Manuel; Morales, Isabel; Novo, Andres; Oltolini, Chiara; Peghin, Maddalena; Luis del Pozo, Jose; Puerta-Alcalde, Pedro; Ruiz-Camps, Isabel; Resat Sipahi, Oguz; Tilley, Robert; Yanez, Lucrecia; Ribeiro Gomes, Marisa Zenaide; Carratala, Jordi; Cuervo, Guillermo; Escrihuela-Vidal, Francesc; Tubau, Fe; Rodriguez Arias, Marisol; Merve Ayaz, Caglayan; Munita, Jose; Gasch, Oriol; Capilla, Silvia; Bochud, Pierre-Yves; Manuel, Oriol; Torre-Cisneros, Julian; Tabares, Salvador; Serrano Lopez, Josefina; Maschmeyer, Georg; Torres, Diego; Abdala, Edson; Bittencourt, Driele Peixoto; El Zein, Saeed; Jabbour, Jean-Francois; Bertz, Hartmut; Peyerl-Hoffmann, Gabriele; Lizasoain, Manuel; Maria Aguado, Jose; Clemencia Correa, Lina; Palop, Begona; Fortun, Jesus; Magnasco, Laura; Cespedes, Roberto; Lopez-Soria, Leire; Pablo Horcajada, Juan; Montaguti, Mia Hold; de Cueto, Marina; Rodriguez-Bano, Jesus; Greco, Raffaella; Cichero, Paola; Bassetti, Matteo; Castaldo, Nadia; Sangro del Alcazar, Paloma; Cardozo, Celia; Garcia-Vidal, Carolina; Aguilar-Company, Juan; Larrosa, Nieves; Uyan-Onal, Ayse; Nazli-Zeka, Arzu; Vasconcelos de Freitas, Wania; da Silva Machado, Amanda Aparecida
    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 onco-haematological 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 multidrug-resistant 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 peer-reviewed publications.
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    The risk of pneumococcal diseases in lung diseases and the importance of adult vaccination
    (2014) Sayıner, Abdullah; Mirici, Arzu; Çilli, Aykut; Uzaslan, Esra; Akova, Murat; Özhan, Mustafa Hikmet; Kılınç, Oğuz
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