Evaluation of Atuna Racemosa Toxicity
Bacterial InfectionsFor thousands of years people in the South Pacific have used Atuna racemosa extract as a topical anti-inflammatory. We, the researchers at the Mayo Clinic, have shown this extract to also have antibacterial properties. While this extract has been used for decades in the South Pacific, a controlled clinical trial to evaluate toxicity has never been performed.
Minocycline Pharmacokinetics (ACUMIN)
Bacterial InfectionThis is a Phase IV, multi-center open-label pharmacokinetic trial studying the pharmacokinetics and pharmacodynamics of a single dose of Minocin IV. Up to 67 subjects will be enrolled to obtain 50 evaluable, ICU patients who are already receiving antimicrobial therapy for a known or suspected Gram-negative infection. The entire study duration will be approximately 16 months and each subject participation duration will be approximately 2 days. The study will be conducted at approximately 13 clinical sites. Each subject will receive a single 200 mg dose of Minocin IV infused over approximately 60 minutes. Each subject will have 7 PK samples collected (1 pre-dose, 6 post-dose) at designated time points over a ~48 hour period following the start of the Minocin IV infusion. The primary objectives are: 1) To characterize minocycline PK at the population level in critically-ill adults, with illness known or suspected to be caused by infection with Gram-negative bacteria and 2) To assess patient-level and clinical covariates associated with minocycline pharmacokinetic properties in critically-ill adults, with illness known or suspected to be caused by infection with Gram-negative bacteria.
TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections....
Skin and Subcutaneous Tissue Bacterial InfectionsThis is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA 200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Approximately 75 to 100 sites globally will participate in this study. Patients with an ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment
Helicobacter Eradication Aspirin Trial
Gastrointestinal Ulcer HaemorrhageBacterial Infection Due to Helicobacter Pylori (H. Pylori)HEAT (Helicobacter Eradication Aspirin Trial) is a large simple double-blind placebo controlled outcomes study of Helicobacter pylori (H. pylori) eradication to prevent ulcer bleeding in aspirin users. It will be run by the University of Nottingham, with recruiting centres across the UK. This trial is funded by the National Institute of Health Research Health Technology Assessment (NIHR HTA) Programme. Aspirin use is widespread and increasing in elderly patients. The main hazard is gastrointestinal bleeding, which may be increasing because of increasing aspirin use. This trial is based on evidence that peptic ulcer bleeding in aspirin users occurs predominantly in H. pylori positive people. Patients will be identified by their GPs, then asked to attend an appointment with a Research Nurse to consent to the trial and take a H. pylori breath test. Those with a positive result will be randomised to receive a one week course of either eradication treatment or placebo. No follow-up visits are required, but instead information will be extracted from the patients' electronic medical record using the MiQuest search tool. The trial will continue until 87 adjudicated events (hospitalisation because of definite or probable peptic ulcer bleeding) have occurred, which would occur after a mean 2.5 patient years of follow-up, if trial assumptions are correct.
Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis
Gram-Negative Bacterial InfectionsSepsis1 moreThis clinical study designed as a prospective, open labelled, multi-centre, RCT will be carried out to evaluate if direct hemoperfusion with polymyxin B immobilized fiber column (PMX) is superior to conventional medical therapy for sepsis, for patients with sepsis arising from abdominal cavity infection, accompanied by the failure of one or more organs. 120 patients (60 treatment/60 control) will be considered in this study. Those patients fulfilling inclusion criteria and not having exclusion criteria will be randomly allocated to one of two study groups. One group will be treated with PMX (PMX group) and the other will receive a "standard therapy" for sepsis (control group). All patients will receive full intensive care management, including fluid resuscitation, vasopressors, antimicrobial chemotherapy, ventilatory support, and renal replacement therapy, if required. Each patient will be followed up for 28 days after study entry.
Moxifloxacin in Preventing Bacterial Infections in Patients Who Have Undergone Donor Stem Cell Transplant...
Breast CancerChronic Myeloproliferative Disorders10 moreRATIONALE: A donor stem cell transplant can lower the body's immune system, making it difficult to fight off infection. Giving antibiotics, such as moxifloxacin, may help prevent bacterial infections in patients who have recently undergone donor stem cell transplant. It is not yet known whether moxifloxacin is more effective than a placebo in preventing bacterial infections in patients who have recently undergone donor stem cell transplant. PURPOSE: This randomized phase III trial is studying moxifloxacin to see how well it works compared with a placebo in preventing bacterial infections in patients who have recently undergone donor stem cell transplant.
Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and...
Gram-negative Bacterial InfectionThis study will assess the pharmacokinetics, safety, and tolerability of single and multiple doses of intravenous ceftazidime-avibactam in hospitalized infants and neonates from 26 weeks gestation to 3 months of age. In Part A of the study all patients will receive a single dose of ceftazidime-avibactam. In Part B all patients will received multiple doses of ceftazidime-avibactam. Efficacy will be assessed in the infants and neonates receiving multiple doses of ceftazidime-avibactam.
Telavancin Pediatric PK Study (Ages >3 Months to 17 Years)
Gram-Positive Bacterial InfectionsThis is a multicenter, open-label, single-dose pharmacokinetic (PK) study. Infants, children, and adolescents will receive a single 10 mg/kg dose of telavancin infused intravenously (IV) over 60 minutes
Study Evaluate the PK Profile of Dalbavancin in Infants and Neonates Patients With Known or Suspected...
Bacterial InfectionsThe purpose of this study is to evaluate the Pharmacokinetic (PK) profile of a single intravenous (IV) infusion dose of dalbavancin, and to evaluate the safety and tolerability of a single dalbavancin IV infusion.
S. Boulardii in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adults With Respiratory...
Prevention & ControlDiarrhea Caused by Drug2 moreAntibiotic-associated diarrhea (AAD) is the most common gastrointestinal complication of antibiotic use, with potentially serious clinical impact. The aim of this study is to assess the efficacy and safety of Saccharomyces boulardii in the prevention of AAD in adult patients with lower respiratory tract infection (LRTI) treated in a hospital. A multicenter, randomized, parallel-group, double-blind, placebo-controlled study is conducted whereby adults who are hospitalized due to LRTI and treated with intravenous antibiotics and randomized to capsules containing S. boulardii or indistinguishable placebo. The outcome measures were: relevant clinical features, gastrointestinal symptoms, and adverse events.