Empirical Use of Fosfomycin as a Single Dose Oral Treatment of Asymptomatic Bacteriuria
试验速览
- 阶段
- 2 期
- 入组人数
- 88
- 主要终点
- Resolution of asymptomatic bacteriuria
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: phosphomycin (Drug)
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.
干预措施: Pre-treatment Urine Culture (Diagnostic Test)
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.
干预措施: Pre-treatment Urine Culture (Diagnostic Test)
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.
干预措施: Post-treatment urine culture (Diagnostic Test)
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.
干预措施: Culture specific antibiotic therapy (Drug)
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.
干预措施: Antimicrobial sensitivity testing (Diagnostic Test)
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.
干预措施: Post-treatment urine culture (Diagnostic Test)
结局指标
主要结局
Resolution of asymptomatic bacteriuria
时间窗: 1 week
Decline in colony forming unit (CFU)/mL or absence of bacterial growth after treatment
次要结局
- Need for further treatment(1 week)
- Need for further investigations(1 week)
- Incidence of adverse drug reactions .(1 week)
研究者
mohammed mahmoud samy
Lecturer in Obstetrics and Gynecology
Ain Shams University