5 results
The primary objective of this efficacy and safety study is to demonstrate that tight control of disease activity using stringent criteria based on CDAI, hs-CRP, fecal Calprotectin, and corticosteroid use improves the rate of mucosal healing 48 weeks…
Primairy objectivesTo study the pharmacokinetics (plasma and cerebrospinal fluid) of meropenem in infants <= 90 days of postnatal age with probable or confirmed bacterial meningitis (BM); To describe the safety profile of meropenem in the…
To assess if short antibiotic treatment (3x24 hours) with an anti-pseudomonal carbapenem (imipenem-cilastatin or meropenem) is safe (NON-INFERIOR) with regard to treatment failure in comparison with extended treatment (at least 9x24hours) of high-…
The primary objective of the study is to evaluate the safety, tolerability, PK, and PD of AL002 administered in single ascending doses in healthy participants and multiple doses in participants with mild to moderate AD.
To assess the influence of dosing guided by AutoK on achieving PK targets and clinical endpoints in intensive care patients with sepsis.