PK/PD and Safety/Tolerability of Two Dosing Regimens of Oral Fosfomycin Tromethamine in Healthy Adults
Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
Summary
Oral dosage regimens for fosfomycin tromethamine (Monurol™) are not established for the
treatment of cUTI. The most common and recommended adult dosage regimen in the literature is
a single-dose sachet containing the equivalent of 3 grams of fosfomycin administered every
other day (QOD) for a total of three doses.
There are a myriad of different oral fosfomycin dosing regimens currently being used in
clinical practice, including up to 3 grams orally twice daily for 7-21 days, but these
regimens are not based on solid pharmacokinetic, pharmacodynamic or safety rationale. Initial
pharmacokinetic studies performed with oral fosfomycin tromethamine primarily examined single
dose regimens and did not use modern day bioanalytical or pharmacokinetic techniques. As the
use of fosfomycin becomes more pervasive in concordance with the increase in multidrug
resistant pathogens, further pharmacokinetic and safety data are needed for more intensive
dosing regimens to support its continued use.
The rationale of this study is that oral fosfomycin tromethamine requires a modern
pharmacokinetic-pharmacodynamic study to identify alternative oral dosage regimens that are
appropriate and safe. This study provided safety/tolerability and clinical pharmacology
information regarding two oral dosing regimens that may have application to treat various
types of infections involving resistant pathogens or when other oral antibacterial options
are not available.
Phase:
Phase 1
Details
Lead Sponsor:
Vance Fowler, M.D.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)