Efficacy of ceftolozane/tazobactam against urinary tract and intra-abdominal infections caused by ESBL-producing Escherichia coli and Klebsiella pneumoniae: a pooled analysis of Phase 3 clinical trials.

Objectives: The increase in infections caused by drug-resistant ESBL-producing Enterobacteriaceae (ESBL-ENT) is a global concern. The characteristics and outcomes of patients infected with ESBL-ENT were examined in a pooled analysis of Phase 3 clinical trials of ceftolozane/tazobactam in patients with complicated urinary tract infections (ASPECT-cUTI) and complicated intra-abdominal infections (ASPECT-cIAI).

Methods: Trials were randomized and double blind.

Efficacy of ceftolozane/tazobactam versus levofloxacin in the treatment of complicated urinary tract infections (cUTIs) caused by levofloxacin-resistant pathogens: results from the ASPECT-cUTI trial.

Objectives: Empirical fluoroquinolone therapy is widely used in treating complicated urinary tract infections (cUTIs), even in areas of high fluoroquinolone resistance. While it is believed that high antibiotic concentrations in urine might be sufficient to overcome and effectively treat infections caused by resistant bacteria, clinical trial data validating this assumption are limited. This post hoc analysis evaluated the efficacy of ceftolozane/tazobactam versus levofloxacin in the subgroup of patients with cUTIs caused by levofloxacin-resistant pathogens in a randomized, controlled trial (NCT01345929/NCT01345955).

Ceftolozane-tazobactam compared with levofloxacin in the treatment of complicated urinary-tract infections, including pyelonephritis: a randomised, double-blind, phase 3 trial (ASPECT-cUTI).

Background: Treatment of complicated urinary-tract infections is challenging due to rising antimicrobial resistance. We assessed the efficacy and safety of ceftolozane-tazobactam, a novel antibacterial with Gram-negative activity, in the treatment of patients with complicated lower-urinary-tract infections or pyelonephritis.

Methods: ASPECT-cUTI was a randomised, double-blind, double-dummy, non-inferiority trial done in 209 centres in 25 countries.

Intrapulmonary penetration of ceftolozane/tazobactam and piperacillin/tazobactam in healthy adult subjects.

Objectives: Appropriate antibiotic exposure at the site of infection is important for clinically effective therapy. This study compared the epithelial lining fluid (ELF) penetration of ceftolozane/tazobactam, which has potent in vitro activity against many Gram-negative pathogens causing nosocomial pneumonia, with that of piperacillin/tazobactam in healthy adult volunteers.

Methods: In this Phase 1, open-label trial, 51 healthy adult subjects were randomized to receive three doses of either ceftolozane/tazobactam 1.

Efficacy and tolerability of IV doripenem versus meropenem in adults with complicated intra-abdominal infection: a phase III, prospective, multicenter, randomized, double-blind, noninferiority study.

Background: Complicated intra-abdominal infections (cIAIs) require surgical intervention and empiric antibacterial therapy. Doripenem, a broad-spectrum carbapenem, provides coverage of key gram-negative and -positive aerobes and anaerobes encountered in cIAI.

Objective: This study was designed to compare the efficacy and safety profile of doripenem and meropenem in hospitalized adult patients with cIAI.

Evaluation of sex differences of fosamprenavir (with and without ritonavir) in HIV-infected men and women.

Purpose: Recent studies focusing on HIV-1-infected women have suggested the existence of sex-related differences in natural history, antiretroviral pharmacokinetics, efficacy, and tolerability. This article analyzes three pivotal trials of the protease inhibitor (PI) fosamprenavir (FPV) with a view to providing a better understanding of potential sex differences in efficacy and safety.

Method: A post hoc, descriptive analysis was performed on data from 700 subjects (26% women) in three trials of FPV to evaluate sex differences with regard to efficacy, rates of discontinuation, and treatment-related adverse events.

Sex differences in pharmacokinetics and toxicity of antiretroviral therapy.

Worldwide, the rate of new HIV infections continues to increase among women. Over the past 5 years there has been a growing focus on the clinical aspects of HIV infection among women. Historically, the majority of subjects enrolled in HIV clinical trials were male patients.

Lipids, metabolic syndrome, and risk factors for future cardiovascular disease among HIV-infected patients.

The availability of potent combination antiretroviral therapy has changed the long-term prognosis for people living with HIV/AIDS. There is increasing concern, however, about the effect of HIV therapy on lipid disorders and subsequent development of coronary artery disease. Virtually all classes of antiretroviral drugs have been associated with some aspect of atherogenic changes in the lipid profiles.

Sex Differences in HIV: Natural History, Pharmacokinetics, and Drug Toxicity.

In the early years of the HIV epidemic, the burden of the disease was principally among men. In recent years, HIV infection among women has become a growing problem worldwide. There is now an increasing awareness that HIV may affect men and women differently.

Corynebacterium jeikeium sepsis after 8-methoxypsolaren photopheresis for cutaneous T-cell lymphoma.

We describe a patient with cutaneous T-cell lymphoma who developed Corynebacterium jeikeium sepsis after experimental treatment with 8-methoxypsolaren. The epidemiology and clinical features of C. jeikeium infection are discussed.