Escherichia coli Infection (E. coli)

Researchers are studying the safety and effects of a medicine combining aztreonam ATM and avibactam AVI to treat infections caused by gram-negative bacteria in newborns and infants up to 9 months old who are hospitalized. This Phase 2a study includes two parts Part A focuses on a single dose, and Part B involves multiple doses, aiming to understand the medicines behavior in the body, safety, and how well it is tolerated. In Part A, hospitalized participants receive a single intravenous infusion of ATM-AVI over 3 hours, with blood samples taken during and after the infusion to study pharmacokinetics and safety. Part B participants receive multiple intravenous infusions every 6 to 8 hours for 3 to 14 days to treat suspected or confirmed infections and assess safety, pharmacokinetics, tolerability, and efficacy. Those with certain infections may also receive additional antibiotics, and participants with good responses may switch to oral antibiotics. The study includes 4 age cohorts and excludes overlapping participation between parts. Participants undergo blood level assessments, clinical evaluations at treatment end and test-of-cure visits, and safety monitoring up to 4 to 5 weeks after treatment. Researchers track adverse events, drug concentrations, and clinical outcomes. An independent committee oversees safety data. The total participation time is about 5 weeks for Part A and up to 7 weeks for Part B.

Researchers are evaluating the use of D-mannose supplementation to prevent recurrent urinary tract infections rUTI in post-menopausal women. This randomized, double-blind, placebo-controlled study aims to improve understanding of rUTI prevention in this population, which is disproportionately affected and understudied. The study tests whether daily D-mannose intake over 6 months and up to one year effectively reduces the occurrence of uncomplicated rUTIs compared to placebo. Participants will be randomly assigned in a 21 ratio to receive either D-mannose 2 grams daily, taken as four 500 mg capsules or a placebo for 12 months. The study follows CONSORT guidelines and includes two groups one receiving the active supplement and the other receiving a placebo. The study aims to enroll 90 women who are currently free of UTI but have a history of recurrent infections. During the study, participants will attend follow-up appointments to monitor urinary tract health through urine cultures and symptom assessments. Researchers will collect data on failure rates, number of antibiotic treatments for UTI, symptom severity, and any serious adverse events related to D-mannose over an average follow-up of five years. This allows long-term observation of the supplements impact on rUTI prevention and safety.

Urinary tract infection UTI is a common bacterial infection affecting millions worldwide, with recurrent cases leading to high antibiotic use and health costs. This trial investigates alternative treatments by studying the ability of a non-pathogenic E.coli strain ABU to prevent recurrent UTIs by outcompeting the harmful bacteria. The study is a placebo-controlled, double-blind clinical trial aimed at strengthening evidence for this approach. Participants will be randomly assigned to one of two groups one receiving bladder flushing with the non-pathogenic ABU bacterial strain as a preventive treatment, and the other receiving bladder flushing with a saline solution as a placebo. This study uses a quadruple-blind design to ensure unbiased results and focuses on evaluating the clinical effect of these interventions in preventing recurrent cystitis. During the 1-year follow-up, participants will undergo various assessments including monitoring the number of UTI events, time to first UTI after intervention, quality of life questionnaires, symptom scoring, and microbiological and laboratory tests. Safety aspects such as complications and hospitalizations will also be tracked. The study includes patients with different bladder conditions and requires regular clinical and microbiological evaluations throughout the trial period.

Researchers are evaluating an investigational phage therapy for adults with spinal cord injury SCI who have neurogenic bladders colonized by Escherichia coli bacteria. This Phase 1b study aims to assess the safety, tolerability, pharmacokinetics PK, and pharmacodynamics PD of the therapy. Participants have bacteriuria and use either indwelling catheters or require intermittent catheterization for bladder drainage. The study is randomized, double-blind, placebo-controlled, and conducted at a single center. About 30 participants will be randomized to receive either the investigational phage therapy or a placebo. The phage therapy involves a personalized mixture of up to three phages targeting the participants dominant E. coli strain. This sterile solution is instilled directly into the bladder via catheter twice daily for 7 days. The placebo group receives sterile saline solution administered the same way and schedule. Treatment includes 14 doses over 7 days, followed by a flush of sterile saline after each dose. Participants may be inpatients or outpatients and will undergo up to 30 days of screening before randomization. After treatment, follow-up visits occur on Days 14, 21, 28, and 35 to monitor safety and collect data. Assessments include adverse event monitoring, pharmacokinetic and pharmacodynamic evaluations, and bladder-related health checks. The total study duration per participant is up to 65 days. Safety and tolerability are the primary outcomes measured during and after treatment.

Researchers are evaluating new home-based methods to measure medication and chemical concentrations in sweat and saliva compared to standard blood tests in patients with chronic or infectious diseases who are receiving medications. The study aims to see if a smart wristband can accurately monitor substances like electrolytes and metabolites in sweat, which may help in health monitoring and disease diagnosis. This pilot observational study is focused on assessing the feasibility of these wearable sweat sensors. Participants provide sweat samples using a Macroduct Sweat Collection System, saliva samples, and blood samples within 24 hours after taking their medications. They also complete short questionnaires lasting 5 to 10 minutes and allow their medical records to be reviewed. The study collects samples and data to compare the new home-based methods against the standard liquid chromatography-mass spectrometry of plasma. During the study, patients are followed periodically after completing sample collection to monitor results and assess feasibility. Researchers measure how well the home-based sampling predicts medication levels and observe plasma concentrations within 4 hours. The study includes ongoing follow-up to evaluate the ease of obtaining home-based samples and to review medical data over time.

This research aims to evaluate the effects of a multi-component chlorination intervention on maternal and neonatal health in public healthcare facilities in western Kenya. The trial focuses on reducing bacterial contamination and antibiotic-resistant infections in neonates born at these facilities. The study is a cluster randomized controlled trial involving 36 health facilities, with a goal to provide evidence on how chlorinated water supply and reliable chlorine disinfectant use impact bacterial contamination and infection rates. Health facilities will be randomly assigned either to a control group or to an intervention group. Intervention facilities will receive passive inline chlorine dosers that automatically treat water used in maternity wards, along with a steady supply of chlorine disinfectant. Half of the intervention sites will produce chlorine on-site using electrochlorinators, while the other half will receive bulk chlorine deliveries. Both intervention and control facilities will receive infection prevention and control messaging. Facilities will also get equipment like mops and spray bottles for surface cleaning. Participants include pregnant adults or mature minors giving birth at enrolled facilities and their newborns. Researchers will collect data over 24 months, assessing bacterial contamination in water, on hands, and on surfaces, as well as gut colonization by pathogenic and antibiotic-resistant bacteria in mothers and neonates. Health outcomes like possible serious bacterial infection and sepsis symptoms will be monitored during the first week after birth. The study will also track neonatal and maternal mortality up to 28 days postpartum to understand the interventions impact on infection and health.

Researchers are evaluating the clinical and antibacterial effects, safety, and pharmacokinetics of the drug Fluorothiazinone compared to a placebo for preventing hospital-acquired gram-negative bacterial infections in patients who are on mechanical ventilation. The study is a randomized, double-blind, placebo-controlled clinical trial conducted by the Gamaleya Research Institute of Epidemiology and Microbiology. Participants are randomly assigned to receive either Fluorothiazinone tablets or a matching placebo. Those in the treatment group take 2400 mg per day 4 tablets twice daily for the first two days, then 1800 mg per day 3 tablets twice daily from day three onward for up to 14 days or until ventilator-associated pneumonia caused by gram-negative bacteria develops. Tablets are taken twice daily, 12 hours apart, 30 minutes after meals. The placebo group follows the same dosing schedule with inactive tablets. During the study, participants are monitored for the development of pneumonia, bloodstream infections, and urinary tract infections associated with mechanical ventilation over a 14-day therapy period. Researchers track the time to infection onset, the proportion of patients affected by infections or septic complications, and any fatal outcomes. Safety, tolerability, and blood levels of Fluorothiazinone are also evaluated. The study includes adult patients in intensive care units who have been on mechanical ventilation for no more than 12 hours and are at high risk of requiring ventilation within 72 hours.

Access to safe drinking water remains a major challenge in rural households of developing countries, leading to millions of deaths annually due to unsafe water sources. This research evaluates a program that provides coupons for free dilute chlorine solution to improve child health by reducing diarrhea, fever, and cough incidents. The study is a large-scale randomized controlled trial conducted at health clinics, assessing the sustained health impacts and behavior related to chlorine use and health clinic visits. Participants are randomly assigned to receive coupons redeemable for a monthly supply of a 150ml bottle of dilute chlorine solution at registered health facilities for 12 months or to a control group that receives no coupons after enrollment. The intervention is delivered via SMS with an ID for coupon redemption after enrollment over a phone call. The study is conducted in collaboration with the Kenya Medical Research Institute at Health and Demographic Surveillance Systems sites. Participants are monitored for chlorine use in drinking water at 6-month intervals up to 36 months, along with assessments of child illness occurrences like diarrhea and fever. Data collection also includes child mortality and verbal autopsies for deceased children, providing valuable information for future studies on the mortality impact of chlorine distribution. The study involves ongoing data collection on self-reported health facility visits and objective measures of chlorine use over the study period.

Metallo--lactamase-producing carbapenem-resistant Gram-negative bacteria MBL-CR-GNB are a serious global health threat due to their ability to break down almost all -lactam antibiotics. Current inhibitors like avibactam cannot stop metallo--lactamases, limiting treatment options. Researchers are studying the combination of ceftazidime-avibactam with aztreonam, which works together to fight these infections. This phase 4 clinical trial aims to compare different infusion methods for this combination in patients with complicated infections caused by MBL-CR-GNB. Participants will receive either a 3-hour simultaneous intravenous infusion of ceftazidime-avibactam 2.5g and aztreonam 2g every 8 hours, or a sequential infusion where ceftazidime-avibactam is given over 2 hours followed by aztreonam over 1 hour every 8 hours. The study is randomized and double-blinded, comparing the effects of these two dosing schedules. Both methods are being evaluated for their ability to reach effective drug levels and their impact on infection outcomes. During the trial, researchers will monitor patients for clinical cure rates within 14 days, microbiological eradication, and any adverse events. Assessments include genotypic testing to confirm bacterial resistance, clinical evaluations, and safety monitoring. The study will follow patients through their treatment period, with careful tracking of infection response and potential side effects to determine if one infusion method offers advantages over the other.

This research aims to evaluate a catheter-free method for delivering medications directly into the bladder, called intravesical instillation. This method is commonly used for conditions such as interstitial cystitisbladder pain syndrome ICBPS, recurrent urinary tract infections, bladder cancer, and post-chemotherapy or post-radiation cystitis. The study investigates whether this approach reduces discomfort and complications while maintaining treatment effectiveness compared to traditional catheter-based methods. The treatment involves using a specialized urological adapter called UroDapter, which attaches to a syringe and is inserted about 6-8 mm into the urethral opening. This allows medication to reach the bladder without catheterization, aiming to minimize pain, discomfort, and risks like urinary tract infections and urethral damage. Patients receive catheter-free intravesical instillation therapy as their physicians recommend, covering various bladder conditions. Participants will be monitored for up to two weeks to assess patient discomfort during the catheter-free instillation. Researchers will also track success rates of the procedure, incidence of urinary tract infections, urethral bleeding, other complications, and patient preference for this method. Data will be collected anonymously to improve treatment protocols, patient satisfaction, and compliance with intravesical therapies.