Patient's Quality of Life Assessment 5 to 10 Years After Hospitalization in Intensive Care Unit...
Quality of LifeSequelaThe aim of this study is to assess patient's quality of life 5 to 10 years after a severe bacterial infection with hospitalization in a intensive unit care. The population is derived from the DIABACT III study. The investigators will include every patient still alive. To evaluate our question, patients and their parents will answer quality of life questionnaires. The investigators will also have telephone interviews with the parents to know somatic and psychological effects on their child. The investigators will see if quality of life and sequelae differ depending on various studied factors.
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of XNW4107 Alone or in Combination...
Bacterial InfectionsThis is a 3-part, first-in-human study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of XNW4107 given as intravenous (IV) infusion in healthy male subjects. In part 1, subjects will receive a single dose of XNW4107. In part 2, subjects will receive XNW4107 for 7 days. In Part 3, subjects will receive XNW4107 in combination with imipenem/cilastatin for 14 days.
Safety of Fluconazole Treatment of Premature and Full-term Newborn Infants
Ductus ArteriosisPatent1 moreThis study will investigate pharmacological interventions between fluconazole and ibuprofen when they are given to premature newborn babys. This in order to find out if the drugs are influencing each other when they are given at the same time. The study is meant to find out if there are reasons to adjust the dose when fluconazole and ibuprofen are given together.
To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)
Complicated InfectionBacterial InfectionsThis is a randomised, double-blind, 3-part study designed to investigate the safety and tolerability of ATM-AVI. The study aims to characterise the pharmacokinetics of ATM-AVI, when both drugs are administered alone (ATM or AVI) and in combination (ATM-AVI), following single administration, and following multiple administrations of ATM-AVI in healthy male and female (females of nonchildbearing potential) volunteers both young and elderly.
Safety and Pharmacokinetics of Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile
Bacterial InfectionsObesityThe purpose of this study is to better understand how clindamycin works in children who fall in the 85th percentile or higher for body mass index (BMI - a ratio of weight to height). The results of the study will help better understand if children in higher BMI ranges process the medication differently and whether dosing should be adjusted in these children.
Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA)
Bacterial InfectionsThe purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single rising and multiple rising IV doses of TR-701 FA and to determine the absolute bioavailability of oral TR-701 FA following single oral and IV dose administrations in healthy adult subjects.
Changes in Microbiota and Iron Status After Iron Fortification of Complementary Foods
Bacterial InfectionsInfants and children under two years are the group with the highest rates of iron deficiency anemia. Provision of sufficient dietary iron to this age group is a challenge, and in-home iron fortification of complementary foods using micronutrient powders can be an effective approach. However, WHO has recently cautioned against untargeted use of in-home micronutrient powders that contain the entire iron RDA for a child in a single dose in areas with high rates of infections from malaria and diarrheal disease. Therefore, in this study, we will investigate the effect on the infant gut microbiota of a low dose (ca. 25% of the RDA) of highly bioavailable iron, provided by a micronutrient powder added to a complementary food. The study aim is to determine if in-home fortification using an iron-containing micronutrient powder in Kenyan infants will improve iron status and/or modify the composition and metabolic activity of the gut microbiota. Active surveillance will be done weekly to monitor the health of the infants. Our study will be done in a subgroup (n=160) of a larger double-blind controlled feeding trial in which 330 infants will be randomized to receive a micronutrient powder containing either 2.5 mg iron or no iron for 1 year. In our substudy, the infants will be studied only over the first 6 months of the 1 year intervention. Blood samples, taken at baseline and after 6 months will be used to define the iron status and the anemia level of the infants. Stool samples (2 at baseline before intervention, 6 throughout the study and additional samples in case of diarrhea) will be obtained for analysis of the gut microbiota. In the entire study (n=330), we will measure changes in iron status over 1 year.
To Evaluate the Pharmacokinetics of XNW4107 in Healthy Adult Young Females and in Healthy Adult...
Bacterial InfectionsThis is a Phase 1, randomized, double-blind, placebo-controlled study to assess the PK, safety and tolerability of XNW4107, imipenem and cilastatin administered by 60-min (± 3 min) IV infusion in healthy adult young females and in healthy adult elderly males and females.
Intrapulmonary Pharmacokinetics of XNW4107, Imipenem and Cilastatin in Healthy Subjects
Bacterial InfectionsThis is a Phase 1, open-label, single-center study of XNW4107 and imipenem/cilastatin administered intravenously.
A Phase 1 TP-271 Oral PK Single Ascending Dose Study
Bacterial InfectionsThe purpose of this study is to determine the safety and tolerability of up to 6 different single ascending oral doses of TP-271, ranging from 25 mg to 300 mg, in healthy adult male or female subjects.