Short-term administration of prulifoxacin: a preventive strategy to reduce Bacillus Calmette-Guerin (BCG)-induced toxicity in patients with superficial bladder cancer

Antibiotic prophylaxis with 3-day course of prulifoxacin 600 mg in superficial bladder cancer patients undergoing Bacillus Calmette-Guerin (BCG) instillations: a prospective, randomised, open-label, controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN90497703

Enrollment

Registered

2008-07-31

Start date

2007-09-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

BCG-induced toxicity in patients with superficial bladder cancer Cancer Malignant neoplasm of bladder

Interventions

Three-day prophylactic administration of prulifoxacin (oral) 600 mg vs no prulifoxacin at each BCG intravesical instillation.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both males and females, age older than 18 2. Intermediate or high risk superficial bladder cancer 3. Indication for BCG intravesical adjuvant therapy after transurethral resection (TUR) 4. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Patient age older than 85 years 2. World Health Organization (WHO) performance status 3 or 4 3. Previous treatment with BCG during the previous 3 months

Design outcomes

Primary

Measure	Time frame
Adverse events classified by the investigator according to a classification grid considering duration and intensity. Total duration of follow-up: 3 months.	—

Secondary

Measure	Time frame
Efficacy of BCG therapy in terms of 3-month cystoscopy findings	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026