the Use of Fosfomycin as a Single Dose Oral Treatment of Asymptomatic Bacteriuria
NCT ID: NCT03548129
Last Updated: 2018-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
88 participants
INTERVENTIONAL
2016-07-31
2018-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
phosphomycin
Single dose 3 gm oral fosfomycin will be taken by mouth on an empty stomach
Pre-treatment Urine Culture
Mid-stream urine sample will be cultured and number of CFU per mL will be determined.
Post-treatment urine culture
Mid-stream urine sample will be cultured and number of CFU per mL will be determined.
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.
Culture specific antibiotic therapy
Culture-specific antibiotic treatment for 5 days
Pre-treatment Urine Culture
Mid-stream urine sample will be cultured and number of CFU per mL will be determined.
Antimicrobial sensitivity testing
Susceptibility of urinary pathogens to various antimicrobials
Post-treatment urine culture
Mid-stream urine sample will be cultured and number of CFU per mL will be determined.
Interventions
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phosphomycin
Single dose 3 gm oral fosfomycin will be taken by mouth on an empty stomach
Culture specific antibiotic therapy
Culture-specific antibiotic treatment for 5 days
Pre-treatment Urine Culture
Mid-stream urine sample will be cultured and number of CFU per mL will be determined.
Antimicrobial sensitivity testing
Susceptibility of urinary pathogens to various antimicrobials
Post-treatment urine culture
Mid-stream urine sample will be cultured and number of CFU per mL will be determined.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
40 Years
FEMALE
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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mohammed mahmoud samy
Lecturer in Obstetrics and Gynecology
Principal Investigators
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Mohamed Samy, MD
Role: PRINCIPAL_INVESTIGATOR
M Samy
Other Identifiers
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phosphomycin
Identifier Type: -
Identifier Source: org_study_id
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