Author Interviews, Critical Care - Intensive Care - ICUs, Hospital Acquired, Infections, Kidney Disease, Merck / 06.10.2018

MedicalResearch.com Interview with: Michelle Hoffman Brown Associate Principal Scientist Merck MedicalResearch.com: What is the background for this study? What are the kidney risks of using colistin to treat carbapenem-resistant bacterial infections? Response: Gram-negative pathogens are responsible for half of all healthcare-associated infections and their ability to resist traditional antibiotics makes them more dangerous for seriously ill patients in a healthcare setting. The need for new approaches to treat these pathogens is essential and this trial aimed to evaluate the efficacy and safety of imipenem/relebactam (IMI/REL) for the treatment of these challenging infections. Nephrotoxicity is a common complication of colistin-based therapy and is the potential adverse experience of greatest concern to prescribing clinicians, limiting its use to treat carbapenem-resistant bacterial infections. Relebactam is a novel β-lactamase inhibitor that restores imipenem activity against many imipenem-non-susceptible strains of Gram-negative pathogens. In the Phase 3 RESTORE-IMI 1 study (NCT02452047), IMI/REL was shown to be as effective as, but better tolerated than, colistin plus imipenem, including as demonstrated by a lower incidence of treatment-emergent nephrotoxicity (prespecified secondary endpoint). This analysis looked at additional renal safety data from the RESTORE-IMI 1 trial.  (more…)
Author Interviews / 06.10.2018

MedicalResearch.com Interview with: Claudia Syueping Crowell, MD Lead author of the study Assistant professor of pediatrics University of Washington and Seattle Children's Hospital MedicalResearch.com: What is the background for this study? What are the main findings?
  • This research was conducted as part of the SMARTT (Surveillance Monitoring for ART Toxicities) study, which is an observational cohort study of HIV exposed uninfected children with the overall aim of studying the long-term safety of fetal and infant exposure to prophylactic antiretroviral (ARV) therapy.
  • This particular analysis was conducted in response to prior studies that showed an increased risk of seizures and other neurologic conditions in children who were exposed to ARVs in utero.
  • The aim of our study was to determine if in utero exposure to any particular ARV is associated with the diagnosis of neurologic conditions later in infancy and childhood.
  • In our cohort of 3747 HIV-exposed uninfected children we found 237 children who had neurologic conditions, 16 of whom were exposed to efavirenz in utero and 4 of whom were exposed to dolutegravir in utero.
  • The most common neurologic diagnoses were microcephaly, febrile seizures, non-febrile seizures and eye related disorders.
  • When comparing various antiretroviral medications, we found that children of women whose ART regimen included efavirenz were more likely to be diagnosed with a neurologic condition than children of women whose ART regimen did not include efavirenz (9.6% vs. 6.2%). This translated to a 60% higher risk of being diagnosed with a neurologic condition in the efavirenz exposed group after controlling for other risk factors.
  • We also found a suggestion of an association between in utero dolutegravir exposure and later diagnosis of a neurologic condition but the number of children exposed to dolutegravir was small (number of exposed children = 94). 
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Author Interviews, MRSA / 05.10.2018

MedicalResearch.com Interview with: Kathryn Dalton, VMD MPH AKC CHF Fellow PhD Student, Davis Lab Environmental Health and Engineering Johns Hopkins Bloomberg School of Public Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: Animal-assisted interventions (or AAI for short) have become increasing popular in hospitals for the emotional and physical benefits they bring to patients. But there is a risk that these therapy dogs could potential spread infectious germs, including MRSA (methicillin-resistantStaphylococcus aureus), to patients. Our study found that therapy dogs can spread MRSA to patients, and children who had more contact with the therapy dog were at higher risk of getting MRSA. But, we used a new cleaning protocol on the dog with an anti-septic shampoo before the visit and anti-septic wipes during the visit. Patients who had more contact with the dog did not have a higher risk of MRSA when the dog was giving this new cleaning protocol, which made the AAI therapy visits safer for the patients. In addition, the patients’ emotional and physical benefits we observed were not changed by using this dog cleaning protocol.       (more…)