drugset / Trial / NCT03177720

Evaluation of Innovative Tools in Development of Antibiotics

NCT03177720

Phase 1 Completed 10 enrolled Medical University of Vienna
RandomizedParallel-groupOpen-labelOther

Summary

The investigators will determine the difference of pharmacokinetics of ciprofloxacin and imipenem between healthy volunteers and intensive care patients suffering from pneumonia in plasma and at the target site - lung - using bronchoalveolar lavage. As additional aspect the feasibility of combining microdosing of C14 ciprofloxacin with microdialysis, saliva sampling and bronchoalveolar lavage is studied by comparing pharmacokinetics of microdose and macrodose.

Timeline

Start
2016-05-29
Primary completion
2021-07-31
Completion
2021-07-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ciprofloxacin Small molecule 400 mg Intravenous
Comparator IMIPENEM ANHYDROUS Small molecule 1000 mg Intravenous

Indications