Investigation of Pharmacokinetic of Antiinfective Therapy in Healthy Subjects and Severely Burned Patients Admitted to the IC

Phase 1

• Conditions: This is an exploratory pharmacokinetic trial in healthy volunteers (cohort A) and patients with severe burns admitted to the ICU (cohort B). The Information retrieved by these investigations will help to optimize antiinfective treatment in burn victims.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2017-002216-14-AT
• Lead Sponsor: Clinical Pharmacology, MUV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-21
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Cohort A:
•Age: 18 – 55 years
•Healthy male subjects
•Good state of health (mentally and physically)
•A signed and dated written informed consent form.
•The subject is able to understand and willing to comply with protocol requirements and timetables, instructions and protocol-stated restrictions.
•Negative serology (human immunodeficiency virus, hepatits B-AG and C-AB) at screening.
•Vital signs should be within the following range:
oSystoloc blood pressure, 90-140 mmHg
oDiastolic blood pressure, 45-90 mmHg
oPuls rate, 45-90 bpm

Cohort B:
As this study involves intubated and unconscious ICU patients, the study will be performed if inclusion and exclusion criteria are fulfilled. Informed consent will be sought from the patient as soon as he/she is able to comprehend the full content of the study.

•Age: > 18
•Male or female
•Burn victims admitted to the ICU
•Patients prior or after surgical reconstruction of the affected wound areas.
•Patients receiving an antimicrobial therapy (clindamycin, meropenem, vancomycin, ceftriaxone, piperacillin/tazobactam or efuroxime) or antimycotic therapy (voriconazol)
•May or may not apply: Patients receiving albumin supplementation for therapeutic purposes (e.g. hypalbuminemia or hypovolemia)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 82
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

Cohort A:
•Any acute or chronic illness or clinically relevant (Investigator’s judgment) abnormality identified on the screening medical assessment, laboratory tests or ECG, unless in the opinion of the Investigator it will not interfere with the study procedures, affect the outcome of the study or compromise the safety of the subject.
•Use of prescription or non-prescription drugs within 7 days or 10 times the elimination half-life (whichever is longer) prior to the first dose of study medication.
•Intake of grapefruit juice within 1 week prior to study day.
•History of severe allergic or anaphylactic reactions to any medication
•Any disease or medical condition considered relevant for proper performance of the study or risk to the patient at the discretion of the investigator

Cohort B:
•Known allergy or hypersensitivity against study drug or drug class
•History of severe allergic or anaphylactic reactions to any medication
•Any disease or medical condition considered relevant for proper performance of the study or risk to the patient at the discretion of the investigator
•Any additional drug treatment and/or medical intervention (e.g. hemofiltration or hemodialysis,..) considered relevant for proper performace of the study or risk to the patient at the discretion of the investigator
•History or presence of significant disease state(s) incompatible with study participation in the judgment of the investigators
•Sero-positivity for human immunodeficiency virus (HIV), all patients will undergo testing prior inclusion
•Sero-positivity for hepatitis B or C virus (HepB antigen, HepC antibody), all patients will undergo testing prior inclusion
•Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified