A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants...
Urinary Tract InfectionsThe purpose of this study is to evaluate the consistency of therapeutic response of gepotidacin at the Test of cure (TOC) Visit (Days 10 to 13) in female participants with acute uncomplicated cystitis with qualifying bacterial uropathogen(s) at baseline that all are susceptible to nitrofurantoin in Japan, with that from global studies (Studies 204989 [NCT04020341] and 212390 [NCT04187144]).
Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult...
Urinary Tract InfectionsCystitisIT001-310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection.
P3 Study to Assess Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best...
Complicated Urinary Tract InfectionAcute Pyelonephritis3 moreThis study is a multi-center, randomized, single-blind, parallel-group study to assess the efficacy and safety, when nacubactam is coadministered with cefepime or aztreonam, compared with best available therapy (BAT), in the treatment of patients with cUTI, AP, HABP, VABP, and cIAI, due to Carbapenem Resistant Enterobacterales.
Shortened Antibiotic Treatment of 5 Days in Gram-negative Bacteremia
Gram-negative BacteremiaUrinary Tract Infection BacterialGNB5 is an investigator-initiated multicentre non-inferiority randomized controlled trial which aims to assess the efficacy and safety of shortened antibiotic for patients hospitalized with a Gram negative bacteremia with a urinary tract source of infection (GNB). Five days after initiation of antimicrobial therapy for GNB, participants are randomized 1:1 to parallel treatment arms: 5 days (intervention) or minimum 7 days (control) of antibiotic treatment. The intervention group discontinues antibiotics at day 5 if clinically stable and afebrile. The control group receives antibiotics for a duration of 7 days or longer at the discretion of the treating physician. The primary outcome is 90-day survival without clinical or microbiological failure to treatment, which will be tested with a non inferiority margin of 10%.
Single Dose Aminoglycosides for Acute Uncomplicated Cystitis in the Emergency Department Setting...
Urinary Tract InfectionsThe purpose of this research study is to determine if gentamicin is as effective treatment of acute uncomplicated cystitis (urinary tract infection) using aminoglycosides versus the current standards of care. The current standards of care in our region are often to prescribe a multi-day antibiotic prescription that is taken multiple times per day whereas gentamicin will be a one-time dose in the emergency department. Gentamicin is the medicine being studied.
Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin...
Complicated Urinary Tract InfectionAcute PyelonephritisPhase 3 study to evaluate the efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in the treatment of complicated urinary tract infections (cUTI) or acute uncomplicated pyelonephritis (AP).
Efficacy and Mechanism of Action of Methenamine Hippurate (Hiprex™) in Women With Recurring Urinary...
Urinary Tract InfectionsThe purpose of this study is to measure the concentration of formaldehyde in the urine of women with recurrent urinary tract infections on Hiprex; and then, assuming its urinary presence is confirmed at the proper acid urinary pH, evaluate if such a therapy has favorable effects in decreasing the rate of recurrent urinary tract infections over time.
Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children
Complicated Urinary Tract InfectionInfection1 moreUrinary tract infections (UTI) are commonly encountered in children, with 7% diagnosed with at least one UTI by the age of 19 years. The evidence for treatment of uncomplicated UTI is clear; oral antibiotics are as good as intravenous (IV) antibiotics, usually for a total of 7 days. Complicated UTIs (cUTIs) on the other hand, are common reasons for hospital admissions for IV antibiotics and constitute a major burden for healthcare systems. There is considerable variation in care for children who present with UTI and have complicating features such as vomiting, dehydration, urological abnormalities or have a previous history of UTI. Australian and international guidelines lack clear, evidence-based recommendations to guide treatment in this group. Without gold standard evidence, these children will continue to receive unnecessary IV antibiotics, longer hospital stays and poorer health outcomes. This multicentre, non-inferiority randomised trial will investigate if One dose - single dose of IV followed by 2 days oral antibiotics is as non-inferior to Three doses for children with UTI and co-existing complicating factors presenting to the Emergency Department (ED). In other words, this study will compare if a single dose of IV antibiotics plus two days oral antibiotics is as clinically effective as 3 doses antibiotics in resolving UTI symptoms at 72 hours after the first dose of IV antibiotics, for complicated UTIs in children presenting to the ED. All participants will receive a total of 7 days of antibiotics for the complicated urinary tract infection. If 1 dose IV and 2 days oral antibiotics is found to be as good as 3 days, the duration of IV antibiotics for complicated UTI can be reduced along with avoidance of the inherent risks of unnecessary hospital admission by administering a single IV dose in an outpatient/ED setting. On the other hand if a single IV dose results in prolonged symptoms or treatment failure, this will inform practice for the proportion of children who have a single dose of IV antibiotics in the ED and are sent home on oral antibiotics. Regardless of the outcome, this trial will inform clinical practice for complicated UTI to improve health outcomes for this group.
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized...
Gram-negative Bacterial InfectionsHospital Acquired Bacterial Pneumonia (HABP)2 moreThe primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections and after multiple-dose administration in hospitalized pediatric participants 3 months to < 18 years of age with suspected or confirmed complicated urinary tract infection (cUTI), hospital-acquired bacterial pneumonia (HABP), or ventilator-associated bacterial pneumonia (VABP).
Clinical Trial of Pivmecillinam Hydrochloride Tablets in the Treatment of Uncomplicated Urinary...
Uncomplicated Urinary Tract Infectionthe purpose of this study is to evaluate the efficacy and safety of pivmecillinam hydrochloride tablets in the treatment of uncomplicated urinary tract infection in China