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Fosfomycin

Generic Name
Fosfomycin
Brand Names
Monurol
Drug Type
Small Molecule
Chemical Formula
C3H7O4P
CAS Number
23155-02-4
Unique Ingredient Identifier
2N81MY12TE
Background

Fosfomycin was discovered in 1969 by scientists at the Spanish Penicillin and Antibiotics Company and is produced by Streptomyces fradiae. It may also be produced synthetically and is commercially available as the disodium salt for intravenous administration and as the calcium or trometamol salt for oral administration. In terms of chemical structure, fosfomycin is a phosphoenolpyruvate analog and contains a phosphonic group and an epoxide ring.

Due to its ease of administration as a single 3-gram oral dose and desirable safety profile, fosfomycin has largely become a first-line therapeutic option for the treatment of uncomplicated urinary tract infections (UTIs) in females. Despite being FDA approved only for urinary tract infections, fosfomycin actually has a broad spectrum of activity and is active against both gram-positive and gram-negative bacteria. As such there is great interest in exploring the usefulness of fosfomycin for indications beyond the treatment of UTIs.

Indication

Fosfomycin is indicated for the treatment of uncomplicated cases of cystitis caused by susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin is not officially indicated for the treatment of pyelonephritis or perinephric abscess, although there have been reported cases of off-label usage in these situations.

Associated Conditions
Complicated Urinary Tract Infection, Uncomplicated Urinary Tract Infections caused by E. coli, Uncomplicated Urinary Tract Infections caused by Enterococcus faecalis
Associated Therapies
-

the Use of Fosfomycin as a Single Dose Oral Treatment of Asymptomatic Bacteriuria

Phase 2
Conditions
Urinary Tract Infection
Interventions
Drug: Culture specific antibiotic therapy
Drug: phosphomycin
Diagnostic Test: Pre-treatment Urine Culture
Diagnostic Test: Post-treatment urine culture
Diagnostic Test: Antimicrobial sensitivity testing
First Posted Date
2018-06-07
Last Posted Date
2018-06-07
Lead Sponsor
Ain Shams University
Target Recruit Count
88
Registration Number
NCT03548129

Efficacy and Safety of Intravenous Fosfomycin in Prosthetic Joint Infection

Phase 4
Conditions
Prosthetic Joint Infection
Interventions
First Posted Date
2017-08-24
Last Posted Date
2018-04-19
Lead Sponsor
Pro-Implant Foundation
Target Recruit Count
224
Registration Number
NCT03260010
Locations
🇩🇪

Charité - Univeristätsmedizin, Berlin, Germany

Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy.

Phase 4
Completed
Conditions
Infection
Complication
Prostate Cancer
Interventions
Drug: Ciprofloxacin
Drug: Trimethoprim/Sulfamethoxazole
Drug: Fosfomycin
Drug: Pivmecillinam/augmentin
First Posted Date
2017-07-24
Last Posted Date
2022-05-10
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
1538
Registration Number
NCT03228108
Locations
🇳🇱

Zuyderland Hospital, Sittard, Netherlands

🇳🇱

Amphia Hospital, Breda, Netherlands

🇳🇱

Radboud University Medical Center, Nijmegen, Netherlands

and more 8 locations

Observational Follow-up Study of REGATTA

Completed
Conditions
Urinary Tract Infections
Interventions
Drug: Arctuvan
Drug: Fosfomycin
Drug: Placebo to Fosfomycin
Drug: Placebo to Arctuvan
First Posted Date
2017-06-05
Last Posted Date
2019-11-27
Lead Sponsor
University Medical Center Goettingen
Target Recruit Count
398
Registration Number
NCT03176563
Locations
🇩🇪

General Practice Koch, Göttingen, Germany

🇩🇪

General Practice Kolb, Göttingen, Germany

🇩🇪

Institute of General Medicine, MHH Hannover, Hannover, Germany

and more 44 locations

Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial

Phase 4
Completed
Conditions
Urinary Tract Infections
Interventions
Drug: Arctuvan
Drug: Fosfomycin
Drug: Placebo to Fosfomycin
Drug: Placebo to Arctuvan
First Posted Date
2017-05-12
Last Posted Date
2019-11-27
Lead Sponsor
University Medical Center Goettingen
Target Recruit Count
398
Registration Number
NCT03151603
Locations
🇩🇪

General Practice Schelp, Bremen, Germany

🇩🇪

General Practice Aden, Braunschweig, Germany

🇩🇪

General Practice Stegemann, Wunstorf, Germany

and more 44 locations

A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)

Phase 3
Completed
Conditions
Iron Deficiency Anemia
Interventions
First Posted Date
2016-03-01
Last Posted Date
2023-07-25
Lead Sponsor
AMAG Pharmaceuticals, Inc.
Target Recruit Count
2014
Registration Number
NCT02694978
Locations
🇵🇷

Clinical Trial Site, Ponce, Puerto Rico

🇺🇸

AMAG Pharmaceuticals, Inc., Waltham, Massachusetts, United States

PK/PD and Safety/Tolerability of Two Dosing Regimens of Oral Fosfomycin Tromethamine in Healthy Adults

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2015-10-07
Last Posted Date
2019-07-30
Lead Sponsor
Vance Fowler, M.D.
Target Recruit Count
19
Registration Number
NCT02570074
Locations
🇺🇸

University of Illinois at Chicago, Chicago, Illinois, United States

Safety, Tolerability and PK 3-Period Crossover Study Comparing 2 Single Doses of ZTI-01 and Monurol® in Healthy Subjects

Phase 1
Completed
Conditions
Pseudomonas Infection
Interventions
First Posted Date
2014-06-30
Last Posted Date
2016-04-04
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
30
Registration Number
NCT02178254
Locations
🇺🇸

Quintiles Phase I Services - Overland Park, Overland Park, Kansas, United States

Study Comparing Nitrofurantoin to Fosfomycin for Acute Urinary Tract Infection in Women

Phase 4
Conditions
Urinary Tract Infections
Cystitis
Interventions
First Posted Date
2013-10-21
Last Posted Date
2017-05-02
Lead Sponsor
University Hospital, Geneva
Target Recruit Count
600
Registration Number
NCT01966653
Locations
🇮🇱

Tel Aviv University, Tel Aviv, Israel

🇵🇱

Lodz University Hospital, Lodz, Poland

🇨🇭

University Hospitals of Geneva, Geneva, Switzerland

Single Dose Monurol for Treatment of Acute Cystitis

Not Applicable
Completed
Conditions
Urinary Tract Infection
Interventions
Drug: TMP/SMX
Drug: Fosfomycin
First Posted Date
2009-09-15
Last Posted Date
2023-06-05
Lead Sponsor
University of Washington
Target Recruit Count
300
Registration Number
NCT00976963
Locations
🇺🇸

University of Washington, Seattle, Washington, United States

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