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1.
IHJ Cardiovascular Case Reports (CVCR) ; 2022.
Article in English | ScienceDirect | ID: covidwho-2061250

ABSTRACT

The ChAdOx1 nCoV-19 adenoviral vector-based vaccine was the first to be approved against COVID-19 in India. Vaccine induced thrombotic thrombocytopenia (VITT) is a rare but serious adverse effect of the ChAdOx1 nCoV-19 vaccine, causing widespread thrombosis and thrombocytopenia. A22-year-old patient, who had undergone mechanical mitral valve replacement, presented to us one week after administration of 1st dose of the ChAdOx1 nCoV-19 Coronavirus vaccine with acute prosthetic heart valve thrombosis (PVT). Laboratory investigations revealed thrombocytopenia and high D-Dimer levels, suggestive of probable VITT. In this report, we highlight the importance of identification of VITT as a cause of PVT and discuss management options.

2.
N Engl J Med ; 386(14): 1327-1338, 2022 04 07.
Article in English | MEDLINE | ID: covidwho-1778677

ABSTRACT

BACKGROUND: There is a need for oral antibiotic agents that are effective against multidrug-resistant gram-negative uropathogens. Tebipenem pivoxil hydrobromide is an orally bioavailable carbapenem with activity against uropathogenic Enterobacterales, including extended-spectrum beta-lactamase-producing and fluoroquinolone-resistant strains. METHODS: In this phase 3, international, double-blind, double-dummy trial, we evaluated the efficacy and safety of orally administered tebipenem pivoxil hydrobromide as compared with intravenous ertapenem in patients with complicated urinary tract infection or acute pyelonephritis. Patients were randomly assigned, in a 1:1 ratio, to receive oral tebipenem pivoxil hydrobromide (at a dose of 600 mg every 8 hours) or intravenous ertapenem (at a dose of 1 g every 24 hours) for 7 to 10 days (or up to 14 days in patients with bacteremia). The primary efficacy end point was overall response (a composite of clinical cure and favorable microbiologic response) at a test-of-cure visit (on day 19, within a ±2-day window) in the microbiologic intention-to-treat population. The noninferiority margin was 12.5%. RESULTS: A total of 1372 hospitalized adult patients were enrolled; 868 patients (63.3%) were included in the microbiologic intention-to-treat population (50.8% of whom had complicated urinary tract infections and 49.2% of whom had pyelonephritis). An overall response was seen in 264 of 449 patients (58.8%) who received tebipenem pivoxil hydrobromide, as compared with 258 of 419 patients (61.6%) who received ertapenem (weighted difference, -3.3 percentage points; 95% confidence interval [CI], -9.7 to 3.2). Clinical cure at the test-of-cure visit was observed in 93.1% of the patients in the microbiologic intention-to-treat population who received tebipenem pivoxil hydrobromide and 93.6% of patients who received ertapenem (weighted difference, -0.6 percentage point; 95% CI, -4.0 to 2.8); the majority of patients with microbiologic response failures at the test-of-cure visit were asymptomatic patients with recurrent bacteriuria. Secondary and subgroup analyses were supportive of the primary analysis. Adverse events were observed in 25.7% of patients who received tebipenem pivoxil hydrobromide and in 25.6% of patients who received ertapenem; the most common adverse events were mild diarrhea and headache. CONCLUSIONS: Oral tebipenem pivoxil hydrobromide was noninferior to intravenous ertapenem in the treatment of complicated urinary tract infection and acute pyelonephritis and had a similar safety profile. (Funded by Spero Therapeutics and the Department of Health and Human Services; ADAPT-PO ClinicalTrials.gov number, NCT03788967.).


Subject(s)
Anti-Bacterial Agents , Carbapenems , Pyelonephritis , Urinary Tract Infections , Administration, Intravenous , Administration, Oral , Adult , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/adverse effects , Anti-Bacterial Agents/therapeutic use , Carbapenems/administration & dosage , Carbapenems/adverse effects , Carbapenems/therapeutic use , Double-Blind Method , Drug Resistance, Multiple, Bacterial , Ertapenem/administration & dosage , Ertapenem/adverse effects , Ertapenem/therapeutic use , Humans , Pyelonephritis/drug therapy , Urinary Tract Infections/drug therapy , Urinary Tract Infections/microbiology
3.
Indian J Public Health ; 65(4): 410-413, 2021.
Article in English | MEDLINE | ID: covidwho-1607361

ABSTRACT

Generation Z has seen drastic changes in the medical sector with the health-care industry constantly updating itself with newer tools to provide quality treatment. The COVID-19 pandemic has greatly tested the services in every aspect of life and has led to an unprecedented increase in the online storage of patient data. Electronic health records (EHRs) are real-time records that make health information of any patient available securely to authorized users. EHRs in the Indian scenario are still in their budding stages, described as "islands of excellence in an ocean of inadequacy." The central institutes and corporate hospitals have implemented it, but the state medical colleges and peripheral health centers have miles to go. These patient data records become an essential tool in physician's decision-making, expertise, and management. One can review the data which is just a click away even after the patients have been discharged, especially in the follow-up period. The current scenario is such that health-care workers and nonhealth-care workers alike share the data of the patients in respect to their records, radiographs, and laboratory data using social media such as WhatsApp, Facebook, and Telegram. In the absence of adequate regulations, the reliability of the EHRs is questionable and doubt creates a preference for the traditional medical services among the health-care workers. To conclude, a clear and precise guideline that can enlighten the patient and health-care workers is the need of the hour. The concerns of online storage of data need to be alleviated and privacy regulations need to be addressed.


Subject(s)
COVID-19 , Humans , India/epidemiology , Pandemics , Reproducibility of Results , SARS-CoV-2
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