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 Turkish Association of Clinical Microbiology and Infectious Diseases, Diabetic Foot Infections Working Group conducted a prospective study to determine the factors affecting the outcomes of diabetic foot infections. A total of 96 patients were enrolled in the study. Microbiological assessment was performed in 86 patients. A total of 115 causative bacteria were isolated from 71 patients. The most frequently isolated bacterial species was Pseudomonas aeruginosa (n = 21, 18.3%). Among cases with bacterial growth, 37 patients (43%) were infected with 38 (33%) antibiotic-resistant bacteria. The mean (±SD) antibiotics cost was 2,220.42 (±994.59) USD in cases infected with resistant bacteria, while it was 1,206.60 (±1,160.6) USD in patients infected with susceptible bacteria (p < 0.001). According to the logistic regression analysis, the risk factors related to the growth of resistant bacteria were previous amputation (p = 0.018, OR = 7.229) and antibiotics administration within the last 30 days (p = 0.032, OR = 3.796); that related to the development of osteomyelitis was wound size >4.5 cm(2) (p = 0.041, OR = 2.8); and that related to the failure of the treatment was the growth of resistant bacteria (p = 0.016, OR = 5.333). Diabetic foot osteomyelitis is usually a chronic infection and requires surgical therapy. Amputation is the accepted form of treatment for osteomyelitis. Limited limb-saving surgery and prolonged antibiotic therapy directed toward the definitive causative bacteria are most appropriate. This may decrease limb loss through amputations. As a result the infections caused by resistant bacteria may lead to a high cost of antibiotherapy, prolonged hospitalization duration, and failure of the treatment.
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