A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells...
Adenovirus InfectionEBV3 moreTo assess the feasibility of donor-derived interferon (IFN)-γ positive select-ed virus-specific T-cells using the cytokine capture system® (CCS) and the safety of subsequent infusion in recipients of hematopoietic stem cell transplantation (HSCT) with treatment refractory post-transplant viral infections. The CCS has already been successfully used in clinical studies in Germany and United Kingdom (UK).
Dose-finding, Pharmacokinetics, and Safety of VABOMERE in Pediatric Subjects With Bacterial Infections...
Bacterial InfectionsA single dose infusion of Vabomere (meropenem-vaborbactam) is being tested for dose-finding, pharmacokinetics, safety, and tolerability in pediatric subjects from birth to less than 18 years of age with serious bacterial infections
Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children,...
Methicillin-Resistant Staphylococcus AureusBacterial Infections1 moreTo determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of Staphylococcus aureus.
Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse...
Joint InfectionA prospective, single-site, double-arm, parallel, interventional, randomized, controlled clinical trial to assess 90-day rate of joint infections in subjects undergoing primary hip replacements after administration of Next Science No-Rinse Solution (hereby referred to as NS) vs SOC (saline irrigation). The Next Science treatment arm will exhibit greater reduction in rate of 90-day post-operative joint infection than SOC (saline) arm
Therapeutic Drug Monitoring in Patients With Difficult-to-Treat Gram-Negative Bacterial Infections...
SepsisHemodynamic Instability3 moreA prospective, open-label, randomized controlled trial will be conducted to evaluate a novel TDM-guided therapy in management of DT-GNB infections. We hypothesize that TDM-guided antibiotic therapy will reduce 14-day all-cause mortality by 6% (absolute risk reduction) in septic patients with DT-GNB infections, when compared to standard therapy. TDM for 11 antibiotics will be performed for all trial patients although test information will be withheld for the standard therapy arm. The primary aim is to compare the 14-day all-cause mortality rates of novel TDM-guided antibiotic dosing versus standard therapy.
Closed Incisional Negative Pressure Wound Therapy in Post-surgical Wound Care of Patients With Periprosthetic...
Wound HealPeriprosthetic Joint InfectionIn the proposed study, we will apply Prevena on the surgical wound right after closure of the wound in the operating theater. Prevena will be used for 7 days, unless there is ongoing infection or much wound drainage that requires debridement. Most periprosthetic joint infections are from hematogenous origin. Hence, it is considered clean wound unless there is a discharging sinus.
Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options
Invasive Fungal InfectionsA study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19):...
Lower Respiratory Tract InfectionParainfluenza2 moreThis study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19.
Short Post-surgical Antibiotic Therapy in Spine Infections - a Prospective, Randomized, Unblinded,...
InfectionWe implement a prospective, randomized, unblinded, non-inferiority trial regarding the duration of systemic, targeted antibiotic therapy after the first surgical debridement for spine infection; randomizing 1:1 between Six and twelve weeks of antibiotic therapy if there is an implant left in place Three and six weeks of antibiotic therapy if there is no implant left
Nurse-led Antimicrobial Stewardship Intervention to Increase Antibiotic Appropriateness in Residential...
Antimicrobial StewardshipUrinary Tract Infections2 moreThe study will explore the impact of a nurse-led bundled antimicrobial stewardship intervention on the appropriateness of antimicrobial use in residential aged care facilities. The intervention will be assessed in a stepped-wedge cluster randomised controlled trial across 14 residential aged care facilities over an 18-month period.