Ignite Creation Date:
2024-05-06 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03548129
Status:
UNKNOWN
Last Update Posted:
2018-06-07
First Post:
2016-06-09
Brief Title:
the Use of Fosfomycin as a Single Dose Oral Treatment of Asymptomatic Bacteriuria
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Empirical Use of Fosfomycin as a Single Dose Oral Treatment of Asymptomatic Bacteriuria
Status:
UNKNOWN
Status Verified Date:
2018-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None