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

• Status: Unknown status
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

Urinary tract infections (UTIs) are the most commonly occurring bacterial infections in women, Asymptomatic bacteriuria (AB) is a common complication during pregnancy, with a prevalence of 2-10%. It has been associated with a greater incidence of symptomatic urinary tract infection (UTI), as well as foetal and obstetric complications. Appropriate treatment reduces the incidence of UTI by 80-90%, as well as the risk of a premature birth and low-birth-weight baby Fosfomycin trometamol (Monuril) is approved in numerous countries worldwide, including various European countries and the USA, mainly for the treatment of uncomplicated UTIs

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antitubercular; Fosfomycin

Criteria

Inclusion Criteria:

1. Pregnant patients from 13 weeks to 36 weeks gestation.

2. Pus cells in urine analysis >5/HPF.

3. ≥ 105 colony-forming units (CFU) per millilitre of the same microorganisms in two consecutive cultures.

4. No symptoms or sings suggestive of urinary tract infection.

Exclusion Criteria:

1. Presence of any urinary symptoms as burning micturition, hesitancy

2. Fever and loin pain.

3. Diabetes mellitus.

4. Known to be allergic from any of the antimicrobial ingredients.

5. Not using any antimicrobial during the course of treatment for any other infection.

6. Not known to have any congenital urinary anomalies.

7. If the patient is taking medications that interact with fosfomycin as:

• Anorexiants (eg, phentermine) or certain sympathomimetics (eg, albuterol, amphetamine, pseudoephedrine) because the risk of their side effects may be increased by fosfomycin.

• Lithium or tetracyclines because their effectiveness may be decreased by fosfomycin.

• Metoclopramide because it may decrease fosfomycin's effectiveness.

8. Impaired kidney functions (creatinine's clearance is <80 ml/min.