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A phase I trial of andrographolide in HIV positive patients and normal volunteers
TLDR
Andrographolide may inhibit HIV‐induced cell cycle dysregulation, leading to a rise in CD4+ lymphocyte levels in HIV‐1 infected individuals, according to this phase I dose‐escalating clinical trial. Expand
Tolerability, Pharmacokinetics, and Serum Bactericidal Activity of Intravenous Dalbavancin in Healthy Volunteers
TLDR
The long half-life and maintenance of SBA against MRSA for 1 week suggest that weekly dosing may be feasible and the long tolerated dose, characterize the pharmacokinetics, and obtain serum bactericidal activity (SBA) data for intravenous dalbavancin are suggested. Expand
Once-weekly dalbavancin versus standard-of-care antimicrobial regimens for treatment of skin and soft-tissue infections.
TLDR
It is suggested that a regimen of 2 doses of dalbavancin administered 1 week apart is effective in the treatment of complicated, gram-positive bacterial SSTIs and warrants further study. Expand
Audiologic monitoring for potential ototoxicity in a phase I clinical trial of a new glycopeptide antibiotic.
TLDR
No subjects demonstrated ototoxic change after receiving dalbavancin, nor were any false-positive results obtained, and the methodology and results for evaluating potential ototoxicity in a phase I clinical trial of a new glycopeptide were described. Expand
Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection
TLDR
Among participants receiving antibiotic treatment for primary or recurrent C. difficile infection, bezlotoxumab was associated with a substantially lower rate of recurrent infection than placebo and had a safety profile similar to that of placebo. Expand
Human pharmacokinetics and rationale for once-weekly dosing of dalbavancin, a semi-synthetic glycopeptide.
TLDR
The efficacy study showed that a two-dose weekly dalbavancin dosage regimen was well tolerated and associated with a higher clinical response rate than the comparator regimens. Expand
Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection in Patients at Increased Risk for Recurrence
TLDR
While participants with ≥3 risk factors had the greatest reduction of rCDI with bezlotoxumab, those with 1 or 2 risk factors may also benefit, and the risk factors prespecified in the MODIFY statistical analysis plan are appropriate to identify patients at high risk for r CDI. Expand
Antibodies to Toxin B Are Protective Against Clostridium difficile Infection Recurrence.
TLDR
A predictor of recurrence was age ≥65 years, and an antibody-mediated immune response to toxin B appears to be protective against rCDI, demonstrating the importance of clinical as well as immunological risk factors in rCDi. Expand
Cost-effectiveness of Bezlotoxumab Compared With Placebo for the Prevention of Recurrent Clostridium difficile Infection
TLDR
Model-based results demonstrated that bezlotoxumab was cost-effective in the prevention of recurrent CDI compared with placebo, among patients receiving SoC antibiotics for treatment of CDI. Expand
The tolerance and pharmacokinetics of clinafloxacin (CI-960) in healthy subjects.
The single-dose tolerance and pharmacokinetics of clinafloxacin, a new fluoroquinolone antibacterial agent, were evaluated in healthy volunteers. Single oral doses of 25, 50, 100, and 200 mg wereExpand
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