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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

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

Fosfomycin Versus Meropenem or Ceftriaxone in Bacteriemic Infections Caused by Multidrug Resistance in E.Coli

Phase 3
Completed
Conditions
Infection Due to ESBL Escherichia Coli
Interventions
First Posted Date
2014-05-20
Last Posted Date
2019-08-06
Lead Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Target Recruit Count
161
Registration Number
NCT02142751
Locations
🇪🇸

Hospital Arnau de Vilanova, Vilanova, Lleida, Spain

🇪🇸

Hospital Royo Villanova, Zaragoza, Spain

🇪🇸

Hospital Universitario 12 de Octubre, Madrid, Spain

and more 19 locations

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

Efficacy of Daptomycin Plus Fosfomycin Versus Daptomycin for Treatment of MRSA Bacteremia

Phase 3
Completed
Conditions
Staph Aureus Methicillin Resistant Bacteremia
Interventions
First Posted Date
2013-07-12
Last Posted Date
2018-01-17
Lead Sponsor
Miquel Pujol
Target Recruit Count
167
Registration Number
NCT01898338
Locations
🇪🇸

Hospital Universitari Mútua de Terrassa, Terrassa, Barcelona, Spain

🇪🇸

Hospital del Mar- Parc de Salut Mar, Barcelona, Spain

🇪🇸

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

and more 15 locations

Efficacy Study of Prophylaxis With Fosfomycin Versus Ciprofloxacin Prior Prostate Biopsy

Phase 4
Completed
Conditions
Urinary Tract Infections
Interventions
First Posted Date
2013-03-04
Last Posted Date
2017-12-13
Lead Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Target Recruit Count
461
Registration Number
NCT01803191
Locations
🇪🇸

Hospital Universitario Virgen de la Arrixaca, El Palmar, Murcia, Spain

🇪🇸

Hospital General Universitario Santa Lucía, Cartagena, Murcia, Spain

🇪🇸

Hospital General Universitario Los Arcos del Mar Menor, San Javier, Murcia, Spain

Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

Phase 3
Completed
Conditions
Iron Deficiency Anaemia
Chronic Kidney Disease
Interventions
First Posted Date
2009-10-14
Last Posted Date
2014-05-20
Lead Sponsor
Vifor Pharma
Target Recruit Count
626
Registration Number
NCT00994318
Locations
🇧🇪

RHMS Baudour - Department of Nephrology and Dialysis, Baudour, Belgium

🇬🇷

General Hospital of Arta - Nephrology Department, Arta, Greece

🇮🇹

Ospedali Riuniti Anzio-Nettuno ASL ROMA H U.O. Nefrologia e Dialisi, Anzio, Italy

and more 16 locations

Single Dose Monurol for Treatment of Acute Cystitis

Not Applicable
Completed
Conditions
Urinary Tract Infection
Interventions
Drug: TMP/SMX
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

Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis

Phase 4
Completed
Conditions
Infective Endocarditis
Interventions
First Posted Date
2009-03-30
Last Posted Date
2018-03-08
Lead Sponsor
Juan A. Arnaiz
Target Recruit Count
50
Registration Number
NCT00871104
Locations
🇪🇸

Hospital Gregorio Marañón, Madrid, Spain

🇪🇸

Hospital Clínic of Barcelona, Barcelona, Catalonia, Spain

🇪🇸

Hospital La Paz, Madrid, Spain

and more 7 locations
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