Phase III Clinical Trial to evaluate Efficacy, Safety and Tolerability of Fosfomycin (Trometamol) Powder 3 g versus Ciprofloxacin Tablets 750 mg in patients with Chronic Bacterial Prostatitis and Chronic Pelvic Pain Syndrome

A Multicentric, Randomized, Open Label, Controlled, Phase III Clinical Trial to evaluate the Efficacy, Safety and Tolerability of Fosfomycin (Trometamol) Powder 3 g versus Ciprofloxacin Tablets 750 mg in patients with Chronic Bacterial Prostatitis and Chronic Pelvic Pain Syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/08/045068

Enrollment

126

Registered

2022-08-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N411- Chronic prostatitis

Interventions

Intervention1: Fosfomycin (Trometamol) Powder 3 g: Patients randomized in Arm A will be administered once daily dose of Fosfomycin (Trometamol) Powder 3 g for the first week (07 days). This will be fo

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.Timepoint: 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	—

Measure

Time frame

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.Timepoint: 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

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Secondary

Measure	Time frame
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. Proportion of patients with microbiological success for Fosfomycin (Trometamol) Powder 3 g as compared to Ciprofloxacin Tablets 750 mg on Day 28. Proportion of patients with microbiological success for Fosfomycin (Trometamol) Powder 3 g as compared to Ciprofloxacin Tablets 750 mg on TOC (at 5 to 18 days from EOT). Timepoint: Day 7, Day 14, Day 28 & EOT	—

Measure

Time frame

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. Proportion of patients with microbiological success for Fosfomycin (Trometamol) Powder 3 g as compared to Ciprofloxacin Tablets 750 mg on Day 28. Proportion of patients with microbiological success for Fosfomycin (Trometamol) Powder 3 g as compared to Ciprofloxacin Tablets 750 mg on TOC (at 5 to 18 days from EOT). Timepoint: Day 7, Day 14, Day 28 & EOT

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Countries

India

Contacts

Public ContactDr Rajan Dubey

CLINEXEL Life Sciences Pvt Ltd

deepaarora@clinexel.com9820648395

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026