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

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ClinicalTrials.gov Identifier: NCT03548129
Recruitment Status : Active, not recruiting
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
mohammed mahmoud samy, Ain Shams University

Tracking Information
First Submitted Date  ICMJE June 9, 2016
First Posted Date  ICMJE June 7, 2018
Last Update Posted Date June 7, 2018
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2018)
Resolution of asymptomatic bacteriuria [ Time Frame: 1 week ]
Decline in colony forming unit (CFU)/mL or absence of bacterial growth after treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2018)
  • Need for further treatment [ Time Frame: 1 week ]
    Either extending the course of treatment into 5 or 7 days regimen or changing the antibiotic in case of inadequate initial response.
  • Need for further investigations [ Time Frame: 1 week ]
    Need for urine culture and sensitivity in fosfomycin group in case of inadequate response on empirical treatment.
  • Incidence of adverse drug reactions . [ Time Frame: 1 week ]
    Incidence of adverse drug reactions as nausea, diarrhea, headache, vaginal itching, runny nose, back pain Side effects from other antibiotics in culture and sensitivity group
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE the Use of Fosfomycin as a Single Dose Oral Treatment of Asymptomatic Bacteriuria
Official Title  ICMJE Empirical Use of Fosfomycin as a Single Dose Oral Treatment of Asymptomatic Bacteriuria
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
Detailed Description

This study aims to compare between the efficacy of empirical use of fosfomycin trometamol and the use of selected antimicrobials according to urinary culture and sensitivity in curing asymptomatic bacteriuria.

All women included in the study will be counseled regarding mode of intervention and informed consent will be obtained. All cases will be subjected to complete history taking, routine antenatal examination and investigations including complete blood picture, kidney functions and urine analysis, treatment of genital infection if diagnosed. Routine obstetric ultrasound examination.

Patients will be randomized into two groups:

  1. Group (A): Fosfomycin group (FG); where all patients will receive empirical 3 gm oral fosfomycin 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.

    Nature: also known as phosphomycin, phosphonomycin, is a broad-spectrum antibiotic, produced by certain Streptomyces species, although it can now be made by chemical synthesis.

    Trade name: Monuril Company: Zambon, Pharma Con Company, Switzerland

  2. Group (B): Culture specific group (CG): where all patients will receive oral antibiotic according to urine culture and sensitivity, oral antibiotics will be given in the form of five days regimen.

How the urine sample will be collected? The caregiver will give the patient a sterile cup and lid, and advice her to wash herself completely then clean the perineal area from anterior to posterior by water and in standing position as male begin to urinate then stop urinating put the sterile cup and catch the rest of urine in it. Do not touch the inside of the cup or the lid. Put the lid on the cup.

One week after completing the course of treatment all patients included in the study will be subjected to colony count evaluation, to figure out the need for:

  1. Urine culture in fosfomycin group in case of inadequate response to treatment and to give antibiotic according.
  2. The change of duration or the type of antibiotic in case of inadequate response to initial treatment in the culture group.

Outcomes

Primary:

  • Resolution of asymptomatic bacteriuria as measured by colony count.
  • Time frame: 1 week

Secondary:

  1. Side effects of fosfomycin as, nausea, diarrhea, headache, vaginal itching, runny nose, back pain Side effects from other antibiotics in culture and sensitivity group
  2. Need for further treatment, either extending the course of treatment into 5 or 7 days regimen or changing the antibiotic in case of inadequate initial response.
  3. Need for further investigations, as urine culture and sensitivity for fosfomycin group in case of inadequate response on empirical treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Urinary Tract Infection
Intervention  ICMJE
  • Drug: phosphomycin
    Single dose 3 gm oral fosfomycin will be taken by mouth on an empty stomach
  • Drug: Culture specific antibiotic therapy
    Culture-specific antibiotic treatment for 5 days
  • Diagnostic Test: Pre-treatment Urine Culture
    Mid-stream urine sample will be cultured and number of CFU per mL will be determined.
  • Diagnostic Test: Antimicrobial sensitivity testing
    Susceptibility of urinary pathogens to various antimicrobials
  • Diagnostic Test: Post-treatment urine culture
    Mid-stream urine sample will be cultured and number of CFU per mL will be determined.
Study Arms  ICMJE
  • Active Comparator: Fosfomycin group (FG)

    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.

    Interventions:
    • Drug: phosphomycin
    • Diagnostic Test: Pre-treatment Urine Culture
    • Diagnostic Test: Post-treatment urine culture
  • Active Comparator: Culture specific group (CG):

    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.

    Interventions:
    • Drug: Culture specific antibiotic therapy
    • Diagnostic Test: Pre-treatment Urine Culture
    • Diagnostic Test: Antimicrobial sensitivity testing
    • Diagnostic Test: Post-treatment urine culture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 24, 2018)
88
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03548129
Other Study ID Numbers  ICMJE phosphomycin
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party mohammed mahmoud samy, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohamed Samy, MD M Samy
PRS Account Ain Shams University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP