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 μg 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.
The aim of this observational prospective study was to compare the effect of fosfomycin tromethanol (FT) and carbapenems (meropenem or imipenem cilastatin) in the treatment of extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli-related complicated lower urinary tract infection (CLUTI). Inclusion criteria were: patients who were aged >18 yr with dysuria or problems with frequency or urgency in passing urine; those with >20 leukocytes/mm³ in urine microscopy and culture-proven ESBL-producing carbapenem or FT-sensitive E. coli in the urine (>10⁵ cfu/mm³); no leukocytosis or fever; and who were treated with ft (oral 3 g sachet x 1 every other night, three times) or carbapenems between march 2005 and January 2006 in our outpatient clinic and hospital. A total of 47 CLUTI attacks in 47 patients (27 FT group, 20 carbapenem group) were observed prospectively. Clinical and microbiological success in the carbapenem and ft groups was similar (19/20 vs 21/27 and 16/20 vs 16/27 p>0.05). Drug acquisition costs were significantly lower in the FT group (p<0.001). Although it is not a randomized controlled study, these data show that ft may be a suitable, effective and cheap alternative in the treatment of ESBL-producing E. coli-related CLUTI.
This study was planned to determine the risk factors of candidemia, and the most common Candida species causing bloodstream infections. A case-control study which included adult patients was conducted over a 1-year period at tertiary-care educational hospitals in Turkey. A total of 83 candidemia episodes were identified during the study period. Candida albicans was the most common species recovered (45.8%) followed by Candida tropicalis (24.1%) Candida parapsilosis (14.5%) and Candida glabrata which was isolated from only four (4.8%) patients. Presence of a urethral catheter (odds ratio [OR] 2.38; 95% confidence interval [CI] 1.09-5.19; P = 0.02), previous use of antibiotics (OR 2.61; 95% CI 1.05-6.46; P = 0.03), RBC transfusions (OR 2.14; 95% CI 1.16-3.94; P = 0.01) and parenteral nutrition (OR 4.44; 95% CI 2.43-8.11; P < 0.01) were found as independent risk factors for candidemia. TPN (Total Parenteral Nutrition) was an independent risk factor for both C. albicans and non-Candida albicans Candida species (P < 0.001). Most of the risk factors were invasive procedures and former medications. We conclude that a great number of candidemia cases are preventable by means of reduction of unnecessary invasive procedures and the use of antimicrobials.
BackgroundHealth care workers' (HCWs) influenza vaccination attitude is known to be negative. The H1N1 epidemic had started in mid 2009 and made a peak in October-November in Turkey. A national vaccination campaign began on November 2nd, 2009. Despite the diligent efforts of the Ministry of Health and NGOs, the attitudes of the media and politicians were mostly negative. The aim of this study was to evaluate whether HCWs' vaccination attitudes improved during the pandemic and to assess the related factors.MethodsThis cross-sectional survey was carried out at the largest university hospital of the Aegean Region-Turkey. A self-administered questionnaire with 12 structured questions was applied to 807 HCWs (sample coverage 91.3%) before the onset of the vaccination programme. Their final vaccination status was tracked one week afterwards, using immunization records. Factors influencing vaccination rates were analyzed using ANOVA, t-test, chi-square test and logistic regression.ResultsAmong 807 participants, 363 (45.3%) were doctors and 293 (36.6%) nurses. A total of 153 (19.0%) had been vaccinated against seasonal influenza in the 2008-2009 season. Regarding H1N1 vaccination, 143 (17.7%) were willing to be vaccinated vs. 357 (44.2%) unwilling. The number of indecisive HCWs was 307 (38.0%) one week prior to vaccination. Only 53 (11.1%) stated that they would vaccinate their children. Possible side effects (78%, n = 519) and lack of comprehensive field evaluation before marketing (77%, n = 508) were the most common reasons underlying unwillingness or hesitation.Among the 749 staff whose vaccination status could be tracked, 228 (30.4%) actually received the H1N1 vaccine. Some of the 'decided' staff members had changed their mind one week later. Only 82 (60%) of those willing, 108 (37%) of those indecisive and 38 (12%) of those unwilling were vaccinated.Indecisive HCWs were significantly younger (p = 0.017). Females, nurses, and HCWs working in surgical departments were more likely to reject vaccination (p < 0.05). Doctors, HCWs working in medical departments, and HCWs previously vaccinated against seasonal influenza were more likely to accept vaccination (p < 0.05). Being younger than 50 and having been vaccinated in the previous season were important predictors of attitude towards pandemic influenza vaccination.ConclusionsVaccination rates increased substantially in comparison to the previous influenza season. However, vaccination rates could have been even higher since hesitation to be vaccinated increased dramatically within one week (only 60% of those willing and the minority of those indecisive were finally vaccinated). We speculate that this may be connected with negative media at the time.
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