Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic...
Proven or Suspected Gram-negative Bacterial InfectionPeri-operative ProphylaxisThe purpose of this study was to assess the pharmacokinetics, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam (MK-7625A) in pediatric participants. In each of the 6 age cohorts, an interim analysis of pharmacokinetics (PK) and safety data was conducted after approximately 3 participants had received the initially proposed dose. The interim analysis was to determine whether the initial dose was appropriate based on pre-defined criteria. If data from the interim analysis demonstrated that the initially proposed dose met the above criteria, enrollment was to continue with the same dose administered to approximately 3 additional participants of the same age range. However, if the interim analysis demonstrated that a new optimized dose was required, the new dose was to be administered to approximately 3 additional participants of the same age range.
Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and...
InfectionsStreptococcal1 moreThe purpose of the present study is to assess and compare in healthy non-pregnant women 18 to 40 years of age the safety and immunogenicity of a liquid formulation of Group B Streptococcus (GBS) Trivalent Vaccine (not requiring reconstitution prior to administration), and of the lyophilized formulation of GBS Trivalent Vaccine, administered in non-pregnant and pregnant women in the clinical development program to date.
Pharmacokinetics and Safety of Solithromycin in Adolescents and Children
Bacterial InfectionPediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17
Aminolaevulinic Acid Photodynamic Therapy of Cervical Persistent HPV Infection and Cervical Neoplasia...
Cervical Persistent High Risk HPV InfectionCervical Intraepithelial NeoplasiaThe study will examine the effect of aminolaevulinic acid (ALA) photodynamic therapy (PDT) of cervical precancerous lesions in women.
Efficacies of Antimicrobial Susceptibility-Guided Versus Empirical Therapy for Rescue Treatment...
Helicobacter Pylori InfectionThe purpose of this study is to assess efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection, then comparing it with 14-day empirical therapy according to personal medication history.
A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan...
Helicobacter PyloriThe purpose of this study is to evaluate the efficacy of helicobacter pylori (HP) eradication with bismuth-containing quadruple therapy with vonoprazan versus esomeprazole in all HP-positive participants.
MicroUDxTM: a Rapid Diagnostic Tool That Will Prevent Death and Disability From Common Infections...
Bacterial Urinary Tract InfectionBackground & Rational: Antibiotics are a major underpinning of modern medicine. The global rise of antimicrobial resistant (AMR) organisms is a serious world health problem. With few new antimicrobial drugs on the horizon, it is imperative that we develop novel approaches to extend the service life of our existing drugs. AMR is a complex problem that is being driven by a wide range of factors. More than half of the antibiotics prescribed have no medical benefit, and outpatient visits for uncomplicated urinary tract infections (UTIs) are a major contributor to this problem. Recent studies have shown that nearly half of people treated for UTIs receive the wrong frontline drug and in 75% of patients, the duration of therapy is inappropriate. Limitations in the current diagnostic technology make it impossible to identify UTI pathogens and measure their antibiotic sensitivities during the short out-patient clinical visits that are typical for most UTI patients. These circumstances result in the inappropriate use of stronger than necessary or inappropriate antimicrobials. The aim of this study is to develop and evaluate a system that can detect bacteria in urine and find the best antibiotic in under 4 hours, thus enabling a rapid diagnosis and use of the most appropriate and cost-effective antimicrobial agent for the agent detected.
Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment...
Urinary Tract InfectionsThe study will be conducted to evaluate the therapeutic response (combined per participant microbiological and clinical response) of oral gepotidacin compared to oral nitrofurantoin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for...
Hepatitis C Virus InfectionThe primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in adults with chronic hepatitis C virus (HCV) infection and compensated cirrhosis.
MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy
HIV-1-infectionThis is a Phase 1, open-label single-center study to determine the safety of MGD014 in participants with human immunodeficiency virus (HIV) infection on stable suppressive antiretroviral therapy (ART).