Antibiotics

Researchers are evaluating the safety, tolerability, and how the body processes (pharmacokinetics) single and multiple intravenous doses of a drug called BWC0977 in healthy adult volunteers. This Phase 1 study involves a total of 64 healthy adults aged 18 to 55 years and is designed as a randomized, double-blind, placebo-controlled trial with multiple dose groups. The study focuses on measuring any treatment-emergent adverse events and serious adverse events to understand the drug's safety profile. Participants will be divided into two main groups: single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. In the SAD phase, volunteers receive one intravenous infusion of BWC0977 or placebo over 2 hours at doses of 750 mg or 1500 mg. In the MAD phase, participants receive multiple intravenous infusions of BWC0977 or placebo over 30 minutes to 2 hours daily for 7 to 10 consecutive days. Dose levels will increase sequentially based on safety and tolerability data collected during the study. During the study, participants will undergo various assessments including physical exams, vital signs, ECGs, laboratory tests, and blood sampling at specific times before, during, and after infusions to monitor safety and measure drug levels in the body. Researchers will track adverse events for up to 8 days after single dosing and up to 16 days after multiple dosing. Volunteers must comply with study visits and requirements throughout the trial, which lasts until August 2026.

Researchers are studying the effects of Huperzine A Injection on reducing postoperative delirium in elderly patients aged 75 and older who are undergoing non-cardiac surgery. This randomized, double-blinded, placebo-controlled trial aims to observe how this treatment may influence the occurrence of delirium after surgery in this older population. Participants will be randomly assigned to receive either Huperzine A Injection or a placebo of 0.9% Sodium Chloride Injection during their non-cardiac surgical procedure. The study includes patients with an anesthesia grade of III to IV and an estimated operation time of at least 2 hours. The treatments will be administered under controlled conditions to carefully assess their effects on postoperative delirium. During the study, participants will be monitored for delirium incidence within 7 days after surgery, with additional evaluations at 24, 48, and 72 hours post-operation. Researchers will also assess the type, severity, and duration of delirium, length of hospital stay, economic costs, complications, mortality rates, and cognitive function using the Mini-mental State Examination and EuroQol scale. Follow-up assessments will continue up to 2 months after surgery, with some evaluations occurring around 30 days after discharge.

Antimicrobial resistance (AMR) is a major global health concern due to the improper use of antibiotics, including leftover use, non-adherence, and pressure on clinicians to prescribe them. In Egypt, this misuse has led to a high rate of multidrug-resistant bacteria. This research aims to assess antibiotic abuse patterns among medical professionals and the public in Gharbia governorate, evaluating awareness about antibiotic resistance and the factors contributing to misuse. The study is a prospective, cross-sectional survey conducted by Tropical Medicine and Public Health Departments at Tanta University Hospital from May to August 2024. It involves a digital and written questionnaire available in Arabic and English, targeting about 1000 participants including physicians, pharmacists, medical students, nursing staff, and the general population. The questionnaire covers demographics, socioeconomic data, antibiotic use behaviors, prescribing practices, and adherence. The study also includes an awareness campaign on proper antibiotic use. Participants will provide informed consent and complete the questionnaire either digitally or on paper. Researchers will gather data on antibiotic use, prescribing habits, adherence, and awareness of antibiotic resistance. Privacy and confidentiality will be maintained through coded identifiers. The main outcomes measured include the prevalence of antibiotic abuse, factors leading to misuse, and awareness levels. The study will run until August 2024 or until the target number of participants is reached.

This research focuses on understanding how antibiotics behave in the bodies of critically ill newborns, infants, and children aged from 1.8 kilograms up to 15 years who are admitted to pediatric intensive care. The study aims to evaluate if current dosing regimens achieve effective blood concentrations of antibiotics such as amoxicillin-clavulanate, piperacillin-tazobactam, vancomycin, teicoplanin, meropenem, ciprofloxacin, and amikacin. This information is important for guiding safe and effective antibiotic use in young patients under intensive care. Participants receive routine clinical care including treatment with one of the listed antibiotics administered through intermittent or continuous infusion. Blood, and in some cases urine, samples are collected from existing arterial or intravenous lines to monitor antibiotic levels. These procedures are performed during usual care without additional experimental treatments. During the study, patients will have their first-dose and steady-state blood concentrations of antibiotics measured and compared with targets for maximum antimicrobial activity. The study also collects urine samples for some antibiotics. Researchers aim to understand how well current antibiotic doses reach desired levels to guide future dosing strategies. Participation involves blood and urine sampling while receiving standard care, with safety monitored throughout the study period, which is expected to last approximately two years.

Researchers are studying how antibiotic exposure during pregnancy affects the gut microbiota and its development in newborns and infants up to 12 months old. This observational project collects biological samples from pregnant women and their babies to understand how antibiotics impact the diversity and function of gut bacteria early in life. The goal is to reveal how antibiotic use influences the growth and development of the infant's gut microbiome. Participants include pregnant women aged 20 to 40 years with natural conception and single pregnancies at 36 weeks or more gestation, along with their newborns who have normal Apgar scores and no serious congenital diseases. The study compares groups with antibiotic treatment during pregnancy, prophylactic antibiotic use, and natural delivery without antibiotics. Samples are collected at multiple time points during pregnancy (12, 24, and 37 weeks) and from newborns at birth, 1 week, and 1, 3, 6, and 12 months. During the study, researchers collect biological specimens to analyze the infant gut microbiome and antibiotic exposure over time. The main outcome is measuring the gut microbiome composition at specified intervals from pregnancy through the first year of life. This project includes healthy volunteers and tracks how antibiotic use during pregnancy may influence infant gut health and development, with participation lasting through the infant's first year.

Researchers are observing how often antibiotics are prescribed to children hospitalized with community-acquired pneumonia and how doctors decide whether antibiotics are needed. The study also records parental satisfaction with the treatment process. It focuses on a pediatric department known for cautious antibiotic use. This observational study aims to understand treatment patterns and outcomes without altering standard care. Children with non-severe community-acquired pneumonia and fever will be followed either with antibiotic treatment or without antibiotics, depending on the attending physician's decision according to hospital procedures. These two groups include children managed with antibiotics and those managed without. Treatment follows the hospital's standard operating procedures without experimental interventions. During the hospital stay, which averages about 7 days, researchers will track antibiotic use rates, disease severity, medical complications, oxygen use, medication use, and hospital stay duration. Parents will be contacted at least 4 weeks after discharge to check for pneumonia recurrence or readmission. Parental satisfaction with care during hospitalization will also be assessed.

This research aims to evaluate if not using antimicrobial prophylaxis is as effective as the traditional single-dose antimicrobial prophylaxis in patients at low risk of infection undergoing single-use flexible ureteroscopic lithotripsy combined with a flexible negative-pressure suction sheath. This international, multicenter, randomized controlled trial investigates infection prevention strategies in urological surgery, focusing on patients with stones up to 2 cm in size and no infection symptoms. Participants will be randomly assigned to one of two groups: one group will not receive any prophylactic antimicrobials before surgery and will only get antibiotics if signs of infection develop afterward. The other group will receive a single intravenous dose of antimicrobial prophylaxis 30-60 minutes before surgery, such as a second-generation cephalosporin or levofloxacin, followed by the same standardized surgical procedure using a flexible negative-pressure sheath. The surgery will use specific sheath sizes and controlled irrigation to maintain low intrarenal pressure with simultaneous stone fragmentation and suction. During the study, patients will undergo surgery performed by experienced surgeons following strict protocols. Researchers will monitor the incidence of Systemic Inflammatory Response Syndrome (SIRS) within 72 hours after surgery as the primary outcome. Data on surgical parameters and patient outcomes will be collected, and participants will be followed closely for signs of infection and recovery. The study is expected to last until December 2027, with participants aged 18 to 75 years included.

Researchers are evaluating different antibiotic treatments for patients in intensive care units who have pneumonia caused by the bacteria Stenotrophomonas maltophilia. The study compares the effects of using one antibiotic (monotherapy) versus a combination of two antibiotics, as well as shorter (7 days) versus longer (14 days) treatment durations. This research also looks at how resistant the bacteria are to antibiotics and how often pneumonia recurs in these patients. The study involves observing patients who meet specific criteria without assigning new treatments directly. It focuses on the antibiotic strategies already being used, comparing their impact on patient survival. The main measurement is survival within 28 days based on the treatment strategy applied. There are no additional experimental interventions since this is an observational study. Participants will be adult patients who were hospitalized in a medical intensive care unit between January 1, 2018, and December 31, 2023, who were intubated and mechanically ventilated with ventilator-associated pneumonia caused by Stenotrophomonas maltophilia. The research team collects data on patient outcomes, antibiotic resistance, and pneumonia recurrence. The study aims to understand which antibiotic approaches may support better survival in this group.

Researchers are evaluating the use of prophylactic antibiotics before intradetrusor injection of onabotulinumtoxinA in patients with overactive bladder (OAB) who are not showing symptoms of urinary tract infection (UTI). This treatment is FDA approved and used when behavioral and oral medication therapies have not controlled OAB symptoms. Since UTIs are a common side effect of this injection and antibiotics are commonly given beforehand, this study aims to determine if antibiotics are necessary for patients without UTI symptoms and with negative urinalysis, addressing concerns about antibiotic overuse and resistance. The study compares two groups: one receiving a single dose of prophylactic antibiotics before the injection, which is the current standard of care, and another receiving no antibiotics prior to the cystoscopic injection of onabotulinumtoxinA. The choice of antibiotic depends on prior urine culture results, allergies, and medical conditions. The trial is randomized and monitors patients for differences in post-procedure symptomatic UTI rates. Participants will be assessed for symptomatic UTI within 14 days after the injection. Secondary measures include improvements in OAB symptoms and rates of side effects like painful urination, bloody urine, and urinary retention over 14 to 30 days. The study involves urine tests, symptom questionnaires, and monitoring for adverse events. The total duration of participation is based on follow-up visits within the first month after treatment to evaluate safety and treatment outcomes.

Researchers are evaluating the use of antibiotics as additional treatments alongside mechanical cleaning for patients with severe periodontitis, an inflammatory disease that damages tooth-supporting tissues and can lead to tooth loss. This trial focuses on how two antibiotic regimens—amoxicillin plus metronidazole and azithromycin—are absorbed and act in the body to optimize dosage and duration while minimizing risks of antibiotic resistance. The study is a randomized, single-blind clinical trial involving 45 patients over 44 months at the University of Geneva. Participants receive standard mechanical cleaning of their teeth in two appointments, followed by one of three antibiotic treatments: amoxicillin plus metronidazole taken three times daily for either 7 days or 3 days, or azithromycin taken once daily for 3 days. Clinical samples such as gingival fluid, saliva, blood, and plaque are collected at various points during and after treatment to measure antibiotic levels and effects on bacteria. The study also monitors safety and adverse events throughout. Throughout the approximately 8-month participation, patients undergo clinical and radiographic exams, sample collection, and follow-up visits at 3 and 6 months to assess bacterial presence and treatment success. Researchers track patient compliance and record any adverse effects. The primary outcome is measuring antibiotic concentrations in bodily fluids at specific days after dosing, while secondary outcomes include changes in bacteria levels, clinical improvements, and safety assessments.