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Urinary Tract Infection

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

Sponsored by Ain Shams University

About this trial

Last updated 7 years ago

Study ID

phosphomycin

Status

Unknown status

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18 to 40 Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 7 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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.

No

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.