A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of...
Gram-negative Bacterial InfectionsBloodstream Infections (BSI)5 moreThe primary objectives of this study are: To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed aerobic Gram-negative bacterial infections To assess the pharmacokinetics (PK) of cefiderocol after single-dose administration of cefiderocol in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed aerobic Gram-negative bacterial infections To assess the safety and tolerability of cefiderocol after multiple-dose administration in hospitalized paediatric participants 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections To assess the PK of cefiderocol after multiple-dose administration in hospitalized paediatric participants 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections
A Study to Assess the Ability of 2% Lidocaine Gel to Reduce the Discomfort of Urethral Catheterization...
Urinary Tract InfectionChildren 0-24 months of age requiring a urethral catheterization for urine collection will be randomized to receive either topical and intraurethral 2% lidocaine or standard of care to assess for the effectiveness of the former in minimizing pain during urethral catheterization. It is hypothesized that administration of 2% lidocaine gel both topically and intraurethrally will confer a greater degree of pain reduction compared to standard of care.
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With...
Complicated Urinary Tract Infection (cUTI) Including Acute PyelonephritisThe purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis
Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Participants With Complicated...
Complicated Urinary Tract InfectionsThe purpose of this study is to assess the efficacy, safety, and pharmacokinetics of eravacycline compared to ertapenem in treating participants with complicated urinary tract infections (cUTI).
Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract Infections
Recurrent Urinary Tract InfectionRecurrent urinary tract infections are quickly becoming a public health obstacle in our aging population. Almost 50% of women have at least one urinary tract infection in their lifetime; following this first infection, there is a 25-35% chance that she will have another infection in the subsequent 3-6 months. With each documented infection, a patient receives anywhere from a three to seven day course of antibiotics for treatment. Repeated courses of antibiotics often lead to the development of multi-drug resistant infections that are difficult to treat with our arsenal of oral medications. It is theorized that most, if not all, urinary tract infections are caused by bacteria from the gastrointestinal tract. If there is a generalized gut dysbiosis due to repeated courses of oral antibiotics, it will likely be difficult to ever adequately treat repeat urinary tract infections. This same theory led to the development and utilization of fecal microbiota transplantation in the treatment of refractory Clostridium difficile diarrhea. There are now several studies that have reported on the efficacy of fecal transplantation in the treatment of C.difficile infections as well as the correction of gut dysbiosis. Given this positive response in treatment of refractory infectious diarrhea, the investigators propose that the correction of gut dysbiosis can also treat refractory recurrent urinary tract infections. Therefore, the investigators propose this pilot study to determine the effectiveness of fecal transplantation in the treatment of refractory, recurrent urinary tract infections.
Betadine Bladder Irrigations vs. Standard of Care Prior to Indwelling Catheter Removal
Catheter; Infection (Indwelling Catheter)Catheter Infection3 moreOver the last decade, there has been great emphasis on reducing the incidence of hospital-acquired infections, including catheter-associated UTI (CAUTI). This study will evaluate the effectiveness of Betadine irrigation solution (2% povidone-iodine) instilled into the bladder immediately prior to indwelling catheter removal to decrease the risk of subsequent bacteriuria, leading to decreased rates of NHSN defined CAUTI.
Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis...
Urinary Tract InfectionsThis is a double-blind, randomized, double-dummy, comparative study in parallel groups of subjects presenting with recurrent cystitis (≥2 episodes within the past 6 months). Subjects will be randomized and treated with one of two presentations of urinary antiseptics containing methenamine and methylthioninium for three days, followed by three days of antibiotic therapy as determined by urine culture and antibiogram. This study aims to assess the efficacy and safety of each treatment.
Nutraceutical Efficacy for rUTI
Urinary Tract InfectionsThis is a study designed to evaluate the efficacy of a nutraceutical as a non-antibiotic treatment to prevent recurrent urinary tract infections in women that have completed menopause and are on vaginal estrogen therapy. An additional group of women with recurrent urinary tract infections that have completed menopause but are not using vaginal estrogen therapy will be followed while taking the nutraceutical. The study length is ninety days from the date that the study participant will be instructed is day 1.
Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized...
Complicated Urinary Tract InfectionAcute PyelonephritisThis study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with complicated urinary tract infections (cUTIs) who are otherwise relatively healthy.
BetaLACTA® Test for Early De-escalation of Empirical Carbapenems in Pulmonary, Urinary and Bloodstream...
PneumoniaUrinary Tract Infections1 moreThe emergence and rapid worldwide spread of Extended- Spectrum Beta-Lactamase-producing enterobacteriaceae (ESBLE) both in hospital and community, led physicians, and notably intensivists, to prescribe more carbapenems, particularly in the most fragile patients such as ICU patients. Unfortunately, the increased carbapenem consumption favored the emergence of carbapenem resistance mechanisms. Moreover, several preliminary results suggest that carbapenem could markedly impact the human intestinal microbiota, Thus, reduction of carbapenem exposure is widely desired both by national and international antibiotic plans. Therefore, the use of rapid diagnostic tests evaluating bacterial resistance to reduce inappropriate exposure to carbapenems could be a relevant solution. Due to its good diagnostic performance, the betaLACTA® test could meet these objectives. Experimental plan : Randomized, open-labeled non-inferiority clinical trial involving an in vitro diagnostic medical device (close to a phase III study), comparing two parallel groups: Experimental group: early carbapenems de-escalation since the second dose, guided by results of the betaLACTA® test performed directly on the bacterial pellet from the microbiological sample positive on direct examination. Control group: carbapenems de-escalation guided by definitive results of the antibiotic susceptibility test obtained 48 to 72h after microbiological sampling (reference strategy).