Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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:
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
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:
Outcomes
Primary:
Secondary:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phosphomycin | Drug | Single dose 3 gm oral fosfomycin will be taken by mouth on an empty stomach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of asymptomatic bacteriuria | Decline in colony forming unit (CFU)/mL or absence of bacterial growth after treatment | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
| Need for further investigations |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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:
Impaired kidney functions (creatinine's clearance is <80 ml/min.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Samy, MD | M Samy | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D005578 | Fosfomycin |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Culture specific antibiotic therapy | Drug | Culture-specific antibiotic treatment for 5 days |
|
| Pre-treatment Urine Culture | Diagnostic Test | Mid-stream urine sample will be cultured and number of CFU per mL will be determined. |
|
| Antimicrobial sensitivity testing | Diagnostic Test | Susceptibility of urinary pathogens to various antimicrobials |
|
| Post-treatment urine culture | Diagnostic Test | Mid-stream urine sample will be cultured and number of CFU per mL will be determined. |
|
Need for urine culture and sensitivity in fosfomycin group in case of inadequate response on empirical treatment.
| 1 week |
| Incidence of adverse drug reactions . | 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 | 1 week |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |