Condition category
Cancer
Date applied
26/07/2008
Date assigned
31/07/2008
Last edited
31/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Rocco Damiano

ORCID ID

Contact details

Magna Graecia University of Catanzaro
Campus Universitario di Germaneto
Catanzaro
88100
Italy
damiano@unicz.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UMG0707

Study information

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

Acronym

Study hypothesis

Prulifoxacin decrease Bacillus Calmette-Guerin (BCG)-induced moderate to severe adverse events by 30%

Ethics approval

Ethics Committee of the Magna Graecia University of Catanzaro, approved in July 2007

Study design

Single-centre, prospective, randomised, open-label, controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

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 names

Prulifoxacin, Bacillus Calmette-Guerin (BCG)

Primary outcome measures

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

Secondary outcome measures

Efficacy of BCG therapy in terms of 3-month cystoscopy findings

Overall trial start date

01/09/2007

Overall trial end date

30/04/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

Participant 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

Recruitment start date

01/09/2007

Recruitment end date

30/04/2008

Locations

Countries of recruitment

Italy

Trial participating centre

Magna Graecia University of Catanzaro
Catanzaro
88100
Italy

Sponsor information

Organisation

Magna Graecia University of Catanzaro (UMG) (Italy)

Sponsor details

Campus Universitario di Germaneto
Catanzaro
88100
Italy

Sponsor type

University/education

Website

http://www.unicz.it

Funders

Funder type

University/education

Funder name

Magna Graecia University of Catanzaro (UMG) (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes