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Last Updated: December 23, 2024

CLINICAL TRIALS PROFILE FOR MONUROL


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All Clinical Trials for MONUROL

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00976963 ↗ Single Dose Monurol for Treatment of Acute Cystitis Unknown status University of Washington N/A 2009-09-01 Urinary tract infecton (UTI) is a very common problem in young healthy women, afflicting approximately one-half of women by their late 20's. One of the most common antibiotics used to treat UTIs is Trimethoprim-sulfa (TMP-SMX), usually for total of three days. However, concerns about increased antibiotic resistance have led to increased interest in studying other antibiotics for UTI. An alternative antibiotic which is also FDA approved for the treatment of UTIs is fosfomycin (Monurol). The effectiveness of fosfomycin in curing UTIs when given as a single dose is not well studied. The purpose of this research study is to determine what the cure rates are with a single dose of fosfomycin versus the more standard 3-day course of TMP-SMX.
NCT02178254 ↗ Safety, Tolerability and PK 3-Period Crossover Study Comparing 2 Single Doses of ZTI-01 and Monurol® in Healthy Subjects Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 2014-08-01 The objective is to determine the safety, tolerability and pharmacokinetics (PK) of 2 single doses of ZTI-01 (1g and 8g infused over 1-hr) and a single dose of the Reference Label Drug, Monurol® (oral sachet, 3g). Subjects will be randomized to a treatment sequence prior to dosing on Day 1 of Period 1 prior to study screening.
NCT02570074 ↗ PK/PD and Safety/Tolerability of Two Dosing Regimens of Oral Fosfomycin Tromethamine in Healthy Adults Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 2016-01-01 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.
NCT02570074 ↗ PK/PD and Safety/Tolerability of Two Dosing Regimens of Oral Fosfomycin Tromethamine in Healthy Adults Completed Vance Fowler, M.D. Phase 1 2016-01-01 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for MONUROL

Condition Name

Condition Name for MONUROL
Intervention Trials
Healthy Subjects 1
Pseudomonas Infection 1
Urinary Tract Infection 1
Urinary Tract Infections 1
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Condition MeSH

Condition MeSH for MONUROL
Intervention Trials
Urinary Tract Infections 2
Infections 1
Infection 1
Pseudomonas Infections 1
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Clinical Trial Locations for MONUROL

Trials by Country

Trials by Country for MONUROL
Location Trials
Spain 5
United States 3
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Trials by US State

Trials by US State for MONUROL
Location Trials
Illinois 1
Kansas 1
Washington 1
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Clinical Trial Progress for MONUROL

Clinical Trial Phase

Clinical Trial Phase for MONUROL
Clinical Trial Phase Trials
Phase 4 1
Phase 1 2
N/A 1
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Clinical Trial Status

Clinical Trial Status for MONUROL
Clinical Trial Phase Trials
Completed 2
Not yet recruiting 1
Unknown status 1
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Clinical Trial Sponsors for MONUROL

Sponsor Name

Sponsor Name for MONUROL
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 2
Gerencia de Atención Primaria, Madrid 1
Instituto de Investigación Sanitaria Aragón 1
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Sponsor Type

Sponsor Type for MONUROL
Sponsor Trials
Other 6
NIH 2
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