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

NCT03548129 | Unknown Phase 2 DMC

• 1 other identifier: phosphomycin
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• Resolution of asymptomatic bacteriuria

  Decline in colony forming unit (CFU)/mL or absence of bacterial growth after treatment

  1 week

Secondary Outcomes (3)

• Need for further treatment

  1 week

• Need for further investigations

  1 week

• Incidence of adverse drug reactions .

  1 week

Study Arms (2)

Fosfomycin group (FG)

ACTIVE COMPARATOR

Pre-treatment Urine culture will be done then all patients will receive empirical 3 gm oral phosphomycin fosfomycin will be taken by mouth on an empty stomach i.e. 2-3 hours after meals preferably in the evening before bed time after emptying the bladder. The contents of 1 packet of Monuril will be dissolved in a glass of water or another non-alcoholic drink and drink immediately. Do not mix with hot water. Do not take fosfomycin in its dry form. Response to treatment will be assessed by post-treatment urine culture.

Drug: phosphomycin; Diagnostic Test: Pre-treatment Urine Culture; Diagnostic Test: Post-treatment urine culture

Culture specific group (CG):

ACTIVE COMPARATOR

Pre-treatment Urine culture and antimicrobial sensitivity testing will be done then all patients will receive oral culture specific antibiotic therapy in the form of five days regimen. Response to treatment will be assessed by post-treatment urine culture.

Drug: Culture specific antibiotic therapy; Diagnostic Test: Pre-treatment Urine Culture; Diagnostic Test: Antimicrobial sensitivity testing; Diagnostic Test: Post-treatment urine culture

Interventions

phosphomycin DRUG

Single dose 3 gm oral fosfomycin will be taken by mouth on an empty stomach

Fosfomycin group (FG)

Culture specific antibiotic therapy DRUG

Culture-specific antibiotic treatment for 5 days

Culture specific group (CG):

Pre-treatment Urine Culture DIAGNOSTIC_TEST

Mid-stream urine sample will be cultured and number of CFU per mL will be determined.

Culture specific group (CG):; Fosfomycin group (FG)

Antimicrobial sensitivity testing DIAGNOSTIC_TEST

Susceptibility of urinary pathogens to various antimicrobials

Culture specific group (CG):

Post-treatment urine culture DIAGNOSTIC_TEST

Mid-stream urine sample will be cultured and number of CFU per mL will be determined.

Culture specific group (CG):; Fosfomycin group (FG)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant patients from 13 weeks to 36 weeks gestation.
• Pus cells in urine analysis \>5/HPF.
• ≥ 105 colony-forming units (CFU) per millilitre of the same microorganisms in two consecutive cultures.
• No symptoms or sings suggestive of urinary tract infection.

You may not qualify if:

• Presence of any urinary symptoms as burning micturition, hesitancy
• Fever and loin pain.
• Diabetes mellitus.
• Known to be allergic from any of the antimicrobial ingredients.
• Not using any antimicrobial during the course of treatment for any other infection.
• Not known to have any congenital urinary anomalies.
• 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.
• Impaired kidney functions (creatinine's clearance is \<80 ml/min.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Fosfomycin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Mohamed Samy, MD

  M Samy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Obstetrics and Gynecology

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 7, 2018
• Study Start: July 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: June 7, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share