Short-term administration of prulifoxacin: a preventive strategy to reduce Bacillus Calmette-Guerin (BCG)-induced toxicity in patients with superficial bladder cancer
| ISRCTN | ISRCTN90497703 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90497703 |
| Protocol serial number | UMG0707 |
| Sponsor | Magna Graecia University of Catanzaro (UMG) (Italy) |
| Funder | Magna Graecia University of Catanzaro (UMG) (Italy) |
- Submission date
- 26/07/2008
- Registration date
- 31/07/2008
- Last edited
- 31/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Rocco Damiano
Scientific
Scientific
Magna Graecia University of Catanzaro
Campus Universitario di Germaneto
Catanzaro
88100
Italy
| damiano@unicz.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre, prospective, randomised, open-label, controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | 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 |
| Study objectives | Prulifoxacin decrease Bacillus Calmette-Guerin (BCG)-induced moderate to severe adverse events by 30% |
| Ethics approval(s) | Ethics Committee of the Magna Graecia University of Catanzaro, approved in July 2007 |
| Health condition(s) or problem(s) studied | BCG-induced toxicity in patients with superficial bladder cancer |
| Intervention | Three-day prophylactic administration of prulifoxacin (oral) 600 mg vs no prulifoxacin at each BCG intravesical instillation. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Prulifoxacin, Bacillus Calmette-Guerin (BCG) |
| Primary outcome measure(s) |
Adverse events classified by the investigator according to a classification grid considering duration and intensity. Total duration of follow-up: 3 months. |
| Key secondary outcome measure(s) |
Efficacy of BCG therapy in terms of 3-month cystoscopy findings |
| Completion date | 30/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 70 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2007 |
| Date of final enrolment | 30/04/2008 |
Locations
Countries of recruitment
- Italy
Study participating centre
Magna Graecia University of Catanzaro
Catanzaro
88100
Italy
88100
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
