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.

In this prospective, randomized, open-label clinical trial, we compared the efficacy and safety of two antibiotic regimens for severe diabetic foot infections (DFI). Sixty-two in-patients with DFI received either piperacillin/tazobactam (Pip-Tazo, n = 30) (4.5 g intravenously every 8h) or imipenem/cilastatin (IMP, n = 32) (0.5 g intravenously every 6h). The mean duration of treatment was 21 days for Pip-Tazo and 24 days for IMP. Twenty-two (73.3%) patients in the Pip-Tazo group and 26 (81.2%) patients in the IMP group had DFI associated with osteomyelitis. Successful clinical response was seen in 14 (46.7%) patients in the Pip-Tazo group and in nine (28.1%) patients in the IMP group [relative risk (RR) 1.6 (95% CI 0.84-3.25), p 0.130]. Two patients in the IMP group and none in the PIP-Tazo group relapsed [RR 2 (0.94-4.24), p 0.058]. Eighty-nine microorganisms were isolated: 38 (43%) Gram-positive and 51(57%) Gram-negative. Among patients with positive culture, 47 (96%) had complete and two (4%) had partial microbiological response. Microbiological response rates were similar in both groups (p 1.000). Amputation was performed in 18 (60%) and 22 (69%) patients in the Pip-Tazo and IMP groups (p 0.739) respectively. Side effects were more common in the Pip-Tazo group (30% vs. 9.4%), but they were generally mild and reversible. In conclusion, although the sample size was small and the results did not reach statistical significance, Pip-Tazo produced a better clinical response rate than IMP in the treatment of severe DFI. There was no significant difference between the treatment groups with respect to microbiological response, relapse and amputation rates.

The aim of this study was to determine the rates, types, clinical features and treatment of osteoarthricular involvement of brucellosis in Turkey. In a restrospective study in adults, we investigated 238 patients diagnosed with brucellosis over a period of 6 years. A diagnosis of brucellosis was established by isolation of Brucella species in blood or by a compatible clinical picture together with a standard tube agglutination titre of > or = 1/160 of antibodies for brucellosis and/or demonstration of an at least four-fold rise in antibody titre in serum specimens taken over 2 or 3 weeks. Osteoarthricular involvement was defined by inflammatory signs in peripheral joints or by unrelieved pain at rest together with radiological alterations and/or radionuclide uptake in any deep joint. Eighty-seven patients (36.5%) had osteoarthricular involvement (58.6% female, 41.4% male), 47 (54.1%) of whom were reported to consume unpasteurised dairy products. The mean age was 32.3 +/- 16 years. Sacroiliitis was the most common involvement (n = 53, 60.9%) followed by peripheral arthritis (n = 17, 19.5%), spondylitis (n = 12, 13.8%) and bursitis (n = 5, 5.7%). During the observation period, 60 (69%) patients with osteoarthricular involvement and radiographic abnormalities. A bone scan was positive in 15 patients with no radiographic abnormalities. All patients received merely medical treatment and relapse occurred in five (5.7%) patients. Sacroiliitis has been determined as the most frequently observed type of osteoarthricular involvement in brucellosis in Turkey.

The objective of this study was to determine prognostic factors related to death from adult tetanus. Fifty-three cases of tetanus, 25 females and 28 males, were treated in Cukurova University Hospital during 1994-2000. The mean age was 46.6 years. Forty-one (77.7%) patients came from rural areas. Most (64.1%) cases had minor trauma, but 19 (35.8%) had deep injuries. The mean incubation period was 11.5 days. Mortality was high (52.8%), caused by cardiac or respiratory failure or complications, and was related to the length of the incubation period. In cases with an incubation period < or = 7 days, the mortality rate was 75% (p 0.07). Mortality was significantly associated with generalised tetanus (p < 0.05), fever of > or = 40 degrees C, tachycardia of > 120 beats/min (p < 0.05), post-operative tetanus (p 0.03), and the absence of post-traumatic tetanus vaccination (p 0.068). Patients who were given tetanus human immunoglobulin or tetanus antiserum (p > 0.05) had similar outcomes. Patients who were given penicillin had a mortality rate similar to patients who were given metronidazole (p 0.15). The mortality rate was higher (92%) in patients with severe tetanus than in patients with moderate disease (53%). By multivariate analysis, the time to mortality caused by tetanus, and also the mortality rate, were both related significantly to age and tachycardia.

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