Association of Intensity of Antipseudomonal Antibiotic Therapy With Risk of Treatment-Emergent Organisms in Children With Cystic Fibrosis and Newly Acquired Pseudomonas Aeruginosa.

Background: While Pseudomonas aeruginosa (Pa) eradication regimens have contributed to a decline in Pa prevalence in people with cystic fibrosis (CF), this antibiotic exposure might increase the risk of acquisition of drug-resistant organisms. This study evaluated the association between antipseudomonal antibiotic exposure intensity and acquisition risk of drug-resistant organisms among children with CF and new Pa infection.

Methods: We utilized data from the Early Pseudomonas Infection Control Clinical Trial (EPIC CT), a randomized controlled trial comparing Pa eradication strategies in children with CF and new Pa.

Evaluating assumptions of definition-based pulmonary exacerbation endpoints in cystic fibrosis clinical trials.

Background: Cystic fibrosis (CF) pulmonary exacerbations can be serious respiratory events and reduction in exacerbation rate or risk are important efficacy endpoints for CF therapeutic trials. Variability in exacerbation diagnoses and treatment have led drug developers to employ "objective" exacerbation definitions combining antimicrobial treatment (AT) and the presence of ≥4 of 12 respiratory criteria (first published by Fuchs et al. [NEJM 1994;331(10):637-42]).

Revision surgeries are associated with significant increased risk of subsequent cerebrospinal fluid shunt infection.

Background: The object of this study was to determine whether cerebrospinal fluid (CSF) shunt revision(s) are associated with increased risk of CSF shunt infection, after adjusting for baseline factors that contribute to infection risk.

Methods: This was a retrospective cohort study of 579 children aged 0-18 years who underwent initial CSF shunt placement between January 01, 1997 and October 12, 2006 at a tertiary care children's hospital. The outcome of interest was CSF shunt infection.

Treatment and microbiology of repeated cerebrospinal fluid shunt infections in children.

Background: A small group of children have second and even more cerebrospinal fluid (CSF) shunt infections (SIs). We sought to describe the treatment approaches used for, and the microbiology of, repeated SIs.

Methods: The study population included 31 children with second shunt infection (SI-2) among those undergoing initial CSF shunt placement and treatment for initial infection at Primary Children's Medical Center.

A pipeline of therapies for cystic fibrosis.

Therapeutics development for cystic fibrosis (CF) involves a coordinated effort among many groups, including individuals with CF and their caregivers, clinical research teams, and those in academia and industry who have discovered and developed the therapeutic strategies. In the United States, the Cystic Fibrosis Foundation (CFF) has devoted over $875 million to facilitate and coordinate this process since 1986, resulting in the clinical development and/or assessment of ~50 drug candidates during that time. The more than 30 compounds currently in the pipeline of Foundation-funded therapeutics are used as a platform to discuss why and how therapeutic strategies are brought into clinical development.