Dosing Colistimethate Every 8 h Results in Higher Plasma Concentrations of Active Colistin Than Every 12-Hourly Dosing without Increase in Nephrotoxicity: A Phase 1 Pharmacokinetics Trial in Healthy Adult Volunteers.

Despite its use for decades, pharmacokinetic (PK) and safety studies on colistin are limited. We conducted a phase l, open-label trial to evaluate the safety and PK of multiple doses of intravenous (IV) and aerosolized colistimethate sodium (CMS) administered separately and in combination. In total, 31 healthy adults were enrolled into three cohorts of 9, 10, and 12 participants, respectively.

Increased Toxicity Among Adolescents and Young Adults Compared with Children Hospitalized with Acute Lymphoblastic Leukemia at Children's Hospitals in the United States.

Adolescent and young adult (AYA) patients (15-39 years old) with acute lymphoblastic leukemia (ALL) have less favorable outcomes and higher treatment-related mortality as compared with older children with ALL. Minimal data exist regarding how well AYA patients tolerate the intensity of chemotherapy at doses and regimens designed for children, and the toxicities suffered by this population at children's hospitals have not been thoroughly characterized. Pediatric Health Information Systems database was queried to analyze health care outcomes in pediatric (ages 10-14) and AYA patients (ages 15-39) with ALL hospitalized between January 1999 and December 2014.

Barriers to post-placental intrauterine device receipt among expectant minority women.

Purpose: We aimed to identify barriers to breastfeeding-compatible post-placental intrauterine devices (IUDs) for expectant predominantly non-Hispanic African-American women.

Materials And Methods: This cross-sectional survey study, conducted at 3 Cleveland community partner locations, enrolled 119 expectant predominantly unmarried but partnered non-Hispanic African-American women. The survey assessed contraceptive, IUD-specific and breastfeeding attitudes and intentions.

Fecal Calprotectin Is Elevated in HIV and Related to Systemic Inflammation.

Background: Fecal calprotectin (FC), a biomarker of gastrointestinal (GI) inflammation, is used in the diagnosis and management of inflammatory bowel disease. HIV infection severely damages gut-associated lymphoid and epithelial tissues leading to GI inflammation that drives systemic inflammation and increases subsequent risk of comorbidities. For the first time, we compared FC concentrations by HIV and antiretroviral therapy (ART) status and determined the relationship to systemic inflammation.

Assessing the Feasibility and Effectiveness of Two Prenatal Breastfeeding Intervention Apps in Promoting Postpartum In-Hospital Exclusive Breastfeeding.

To test the feasibility and possible effects of two iPad-based breastfeeding interventions for expectant minority women and evaluate (1) the intervention effect on exclusive breastfeeding (EBF) intention, (2) intervention acceptability and satisfaction, and (3) follow-up rates of in-hospital EBF. This was a longitudinal survey study with follow-up chart review. Expectant women who completed clinically required breastfeeding education were eligible and were assigned to one of the following interventions by nonrandomized block design: the champion intervention utilized a free commercially available app to identify a supportive breastfeeding champion and the positive messaging intervention offered breastfeeding information in a question-answer format.

A two-part phase 1 study to establish and compare the safety and local tolerability of two nasal formulations of XF-73 for decolonisation of Staphylococcus aureus: A previously investigated 0.5mg/g viscosified gel formulation versus a modified formulation.

Objectives: Successful decolonisation of nasal Staphylococcus aureus (SA) carriage by mupirocin is limited by increasing drug resistance. This randomised, open-label, phase 1 study compared the safety and local tolerability of two nasal formulations of XF-73, a novel porphyrinic antibacterial with rapid intrinsic activity against SA.

Methods: The study was performed in 60 healthy adults.

Weight-Related Teasing of Adolescents Who Are Primarily Obese: Roles of Sociocultural Attitudes Towards Appearance and Physical Activity Self-Efficacy.

Adolescents who are obese are at risk for being teased about their appearance with the concomitant negative psychological sequelae. Identifying modifiable variables associated with teasing could inform pediatric weight-management interventions. Characterizing society's role in the victimization of these at-risk individuals could guide anti-bullying programs for schools and broader public health efforts.

Effects of Rifamycin Coadministration on Bedaquiline Desmethylation in Healthy Adult Volunteers.

There is an urgent need to identify safe and effective combination treatments for multidrug-resistant (MDR) Mycobacterium tuberculosis infection (TB). Bedaquiline, a new diarylquinoline, is approved for the treatment of MDR pulmonary TB in combination with other drugs, which could include rifabutin, which is also used to treat drug-resistant TB. Both rifabutin and bedaquiline are metabolized via cytochrome P450 3A4, and rifabutin is an inducer of this enzyme.

Mycobactericidal activity of bedaquiline plus rifabutin or rifampin in ex vivo whole blood cultures of healthy volunteers: A randomized controlled trial.

Background: Bedaquiline, an antimycobacterial agent approved for drug-resistant tuberculosis, is metabolized by CYP3A4, an hepatic enzyme strongly induced by rifampin, an essential part of drug-sensitive tuberculosis treatment. We examined the pharmacokinetic interactions of bedaquiline plus either rifampin or rifabutin in 33 healthy volunteers. This sub-study of that trial examined the mycobactericidal activity of these drugs against intracellular Mycobacterium tuberculosis using ex vivo whole blood culture.

Impact of Rifabutin or Rifampin on Bedaquiline Safety, Tolerability, and Pharmacokinetics Assessed in a Randomized Clinical Trial with Healthy Adult Volunteers.

Bedaquiline is a diarylquinoline that specifically inhibits mycobacterial ATP synthase. Bedaquiline has been used to effectively treat tuberculosis (TB) caused by drug-susceptible and drug-resistant Rifamycins are a cornerstone of combination drug regimens for the treatment of TB. This phase 1, open-label, randomized, controlled trial evaluated the effect of steady-state dosing of rifabutin or rifampin on the safety, tolerability, and pharmacokinetics of bedaquiline given as a single dose.

Vitamin D supplementation decreases immune activation and exhaustion in HIV-1-infected youth.

Background: Heightened immune activation and exhaustion drive HIV disease progression and comorbidities. Vitamin D has pleiotropic immunomodulatory effects, but little is known about the effects of supplementation in HIV. Our study investigates changes in immune activation and exhaustion markers after 12 months of supplementation in virologically suppressed HIV-infected youth with vitamin D insufficiency.

Safety, Tolerability, Systemic Exposure, and Metabolism of CRS3123, a Methionyl-tRNA Synthetase Inhibitor Developed for Treatment of Clostridium difficile, in a Phase 1 Study.

causes antibiotic-associated diarrhea and is a major public health concern. Current therapies disrupt the protective intestinal flora, do not reliably prevent recurrent infections, and will be decreasingly effective should less susceptible strains emerge. CRS3123 is an oral agent that inhibits bacterial methionyl-tRNA synthetase and has potent activity against and aerobic Gram-positive bacteria but little activity against Gram-negative bacteria, including anaerobes.

Neurocognitive dysfunction in HIV-infected youth: investigating the relationship with immune activation.

Background: HIV-infected individuals are at increased risk of neurocognitive impairment compared to the general population. Studies suggest that, despite combination antiretroviral therapy (cART), HIV infection causes immune activation which results in neural damage; however, few data exist in HIV-infected youth.

Methods: HIV-infected youth 8-26-years-old on cART with virological suppression were prospectively enrolled along with healthy controls.

Arterial stiffness in HIV-infected youth and associations with HIV-related variables.

Children and young adults infected with HIV are at elevated risk for cardiovascular disease (CVD). However, scarce data exist on the utility of non-invasive methods to diagnose subclinical CVD, such as pulse wave velocity (PWV), a non-invasive measure of arterial stiffness. The objectives of this study were to assess the relationship of carotid-femoral PWV with subclinical atherosclerosis measured by carotid intima-media thickness (IMT), compare measurements to healthy controls, and evaluate variables associated with PWV in HIV-infected youth.

Breast for Success: A Community-Academic Collaboration to Increase Breastfeeding Among High-Risk Mothers in Cleveland.

Background: Exclusive breastfeeding is the optimal method of infant feeding. However, breastfeeding rates are notable for profound health disparities, for example, among inner-city African American women. Community-academic partnership offers an opportunity to intervene.

Effect of the Knowledge and Attitudes of a Support Person on Maternal Feeding Choice.

Background: Breastfeeding rates among urban, low-income populations are lower than the national average, and social support can affect breastfeeding initiation and duration both positively and negatively. Research aim: This study aimed to determine the effect of the presence of a support person and breastfeeding knowledge and attitudes of that person on a mother's feeding choice and perceived level of support for her choice.

Methods: Questionnaires were administered to 192 mothers receiving care for their infants in the Pediatric Practice at University Hospitals Rainbow Babies and Children's Hospital in Cleveland, Ohio, along with 74 adults accompanying these mothers.

Increased Immune Activation and Exhaustion in HIV-infected Youth.

Background: Immune activation and exhaustion drive several comorbidities and disease progression in HIV-infected adults; however, they are not well studied in HIV-infected youth. Thus, this study sought to examine levels of immune activation and exhaustion in this population, investigate associated HIV- and non-HIV-related variables and compare results with a matched healthy control group.

Methods: HIV-infected youth 8-25 years of age on stable antiretroviral therapy with an HIV-1 RNA level <1000 copies/mL were enrolled, along with matched healthy controls.

Kallistatin levels in HIV-infected patients and effects of statin therapy.

Background: Kallistatin, a serine proteinase inhibitor, has vasodilatory and anti-inflammatory properties and is increased in other inflammatory conditions. We measured kallistatin in HIV for the first time, examined its relationship with inflammation, and determined if statin therapy affected levels.

Methods: Kallistatin levels were measured in subjects from a randomized, double-blinded, placebo-controlled trial.

Engaging Inner-City Fathers in Breastfeeding Support.

Purpose: Our objective was to pilot a method of engaging fathers/partners of high-risk inner-city mothers in breastfeeding support.

Materials And Methods: Breast for Success was a breastfeeding promotion initiative with a father engagement component. In collaboration with Community Endeavors, Inc.