A Multicentric, Randomized, Open Label, Controlled, Phase III Clinical Trial to evaluate theEfficacy, Safety and Tolerability of Fosfomycin (Trometamol) Powder 3 g versusCiprofloxacin Tablets 750 mg in patients with Chronic Bacterial Prostatitis and Chronic Pelvic Pain Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 15
- 主要终点
- microbiological success in patients with chronic bacterial prostatitis and Chronic pelvic pain syndrome with Fosfomycin (Trometamol) Powder 3 g versus Ciprofloxacin Tablets 750 mg at the end of treatment when compared to the baseline values. Microbiological success is defined as a reduction of the bacteria to 103 CFU/ml post treatment with IMP(s) at end of treatment visit(s) when assessed by the 2-glass test.
研究概览
简要总结
As per the Treatment Guidelines by ICMR, 2019, Ciprofloxacin is the empirical antibiotic recommended in prostatitis, due to its broad-spectrum antibacterial activity, good bioavailability, and high concentrations in the prostatic tissue. Globally, as well as in India, high rates of quinolone resistance (>20%) are being reported. Antibiotic options for prostatitis are limited as only a few antibiotics are able to achieve high concentrations in the prostate. Therefore, the treatment of chronic bacterial prostatitis is an unmet medical need.
Fosfomycin is an old antibiotic, discovered in 1969 and approved as an oral and intravenous formulation. It is a broad-spectrum antibiotic achieving high concentrations in the prostate and urinary tract. Sensitivity of Escherichia coli (E. coli) the main causative organism for prostatitis to fosfomycin remains high. Further, as per the Indian Council of Medical Research’s (ICMR) Antimicrobial Resistance Research and Surveillance Network, Annual Report, 2020, sensitivity of Enterococcus faecalis (E. faecalis), another key organism in prostatitis to fosfomycin has increased in the recent years. There are several studies and case reports in the published literature that have demonstrated the efficacy of fosfomycin to achieve microbiological and clinical cure in the patients of chronic bacterial prostatitis and due to the widespread resistance to the fluoroquinolones, co-trimoxazole and tetracyclines, use of fosfomycin in prostatitis in increasing in India.
Currently, the indication of prostatitis is not approved for fosfomycin. Therefore, this comparative clinical trial of fosfomycin with ciprofloxacin is planned to evaluate the efficacy and safety of oral fosfomycin in CBP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Patients with history of chronic prostatitis and chronic [elvic pain syndrome 2.Current clinical signs and symptoms of chronic prostatitis and chronic pelvic pain syndrome.
- •3.Laboratory evidence of CBP at Screening visit 4.Willing to adhere to the prohibitions and restrictions specified in this protocol.
排除标准
- •1.Known hypersensitivity or allergy to antibacterial fluoroquinolones or fosfomycin or to any components of the trial medications.
- •2.Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the screening assessment that could interfere with the objectives of the trial or the safety of the patient.
- •3.Patients with known history of prostatic absces.
结局指标
主要结局
microbiological success in patients with chronic bacterial prostatitis and Chronic pelvic pain syndrome with Fosfomycin (Trometamol) Powder 3 g versus Ciprofloxacin Tablets 750 mg at the end of treatment when compared to the baseline values. Microbiological success is defined as a reduction of the bacteria to 103 CFU/ml post treatment with IMP(s) at end of treatment visit(s) when assessed by the 2-glass test.
时间窗: at end of treatment on day 42 for Fosfomycin (Trometamol) Powder 3 g and at end of treatment on day 28 for Ciprofloxacin Tablets 750 mg
次要结局
- Proportion of patients with microbiological success for Fosfomycin (Trometamol) Powder 3 g as compared to Ciprofloxacin Tablets 750 mg on Day 7.(Proportion of patients with microbiological success for Fosfomycin (Trometamol) Powder 3 g as compared to Ciprofloxacin Tablets 750 mg on Day 14.)