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Bacterial InfectionsPhase 3NCT00670215

BAYQ3939, 1000 mg Tablet in Transrectal Needle Biopsies of the Prostate (TRNBP) - Infection Prophylaxis

A Phase 3 study testing Ciprofloxacin single dose and Ciprofloxacin triple dose in people with Bacterial Infections, run by Bayer at 51 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of this clinical trial is to compare in a double-blind randomized trial, the efficacy and safety of ciprofloxacin MR 1000 mg tablets given as a single-dose or as a multiple-dose regimen for the prevention of infectious complications in patients undergoing transrectal needle biopsies of the prostate… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Bacterial Infections
What is being tested?
Ciprofloxacin single dose and Ciprofloxacin triple dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
497 participants
Where
51 sitesin 6 countries
Study dates
Apr 2004to Oct 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Transrectal needle biopsy of the prostate required.
  • A clean-catch midstream-urine (MSU) culture negative (<104 CFU/mL) for possible pathogens at the Pre-Therapy Visit prior to the TRNBP.
  • Gastrointestinal absorption is adequate as evidenced by passage of gas or feces per rectum and patient can tolerate oral food, fluids, and medication without vomiting or diarrhea.

Who cannot join

  • History of hypersensitivity to ciprofloxacin or other quinolone antibiotics
  • Valvular heart disease that requires antibiotic prophylaxis to prevent bacterial endocarditis
  • Concomitant use of theophylline, probenecid, or warfarin at any time during the entire study
  • Renal insufficiency
  • Known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold
  • Absolute neutrophil count (ANC) <1000/mm3
Show all 9Show fewer
  • Human immunodeficiency virus (HIV) infection with a CD4 count <200 cells/micL. HIV testing is NOT required
  • Antibiotic administration within one week of the TRNBP
  • Severe hepatic insufficiency (Child-Pugh C)

Trial locations and contacts

51 sites in 6 countries.

51 sites in 6 countries

United States18 sites

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Cincinnati, Ohio, 45212-2787

  • Study site

    Columbus, Ohio, 43214-1419

  • Study site

    Hopedale, Massachusetts, 01747

  • Study site

    New Brunswick, New Jersey, 08901

  • Study site

    Norfolk, Virginia, 23510

  • Study site

    Ocala, Florida, 34474

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Roswell, Georgia, 30076

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92101

  • Study site

    San Francisco, California, 94117

  • Study site

    Sherman Oaks, California, 91403

  • Study site

    Simpsonville, South Carolina, 29681

  • Study site

    Spokane, Washington, 99202

  • Study site

    Waterbury, Connecticut, 06708

Other trials in United States

Canada12 sites

  • Study site

    Calgary, Alberta, T2V 4R6

  • Study site

    Chicoutimi, Quebec, G7H 1H2

  • Study site

    Edmonton, Alberta, T6G 2C8

  • Study site

    Fleurimont, Quebec, J1H 5N4

  • Study site

    Hamilton, Ontario, L8N 1T8

  • Study site

    Kingston, Ontario, K7L 2V7

  • Study site

    Laval, Quebec, H7G 2E6

  • Study site

    London, Ontario, N6A 4V2

  • Study site

    Québec, Quebec, G1S 2L6

  • Study site

    Toronto, Ontario, M4H 1C3

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Victoria, British Columbia, V8R 6T9

Other trials in Canada

Mexico6 sites

  • Study site

    México D.F., Mexico, 06720

  • Study site

    México, D. F., 06700

  • Study site

    México, D.F., 07760

  • Study site

    Monterrey, 64320

  • Study site

    Villahermosa, Tabasco, 86158

  • Study site

    Zapopan, Jalisco, 45170

Other trials in Mexico

Brazil5 sites

  • Study site

    Belo Horizonte, Minas Gerais

  • Study site

    Porto Alegre, Rio Grande do Sul, 90470 340

  • Study site

    Rio de Janeiro

  • Study site

    Salvador, Estado de Bahia, 41920 000

  • Study site

    São Paulo, São Paulo, 04039-004

Other trials in Brazil

Italy5 sites

  • Study site

    Bergamo, 24128

  • Study site

    Milan, 20132

  • Study site

    Naples, 80131

  • Study site

    Padova, 35128

  • Study site

    Roma, 00155

Other trials in Italy

Spain5 sites

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Madrid, Madrid, 28034

  • Study site

    Seville, Sevilla, 41014

  • Study site

    Valencia, Valencia, 46009

  • Study site

    Vigo, Pontevedra, 36214

Other trials in Spain

About this study

Official title: Prospective, Randomized, Double-blind, Comparison of Ciprofloxacin Extended-release 1000 mg Tablets Given as Two Different Prophylactic Dosing Regimens (Regimen I - Single-dose Ciprofloxacin MR 1000 mg or Regimen II - Multiple-dose Ciprofloxacin MR 1000 mg Once Daily for 3 Days) for the Prevention of Post-operative Infectious Complications in Patients Undergoing Transrectal Needle Biopsy of the Prostate

The primary purpose of this clinical trial is to compare in a double-blind randomized trial, the efficacy and safety of ciprofloxacin MR 1000 mg tablets given as a single-dose or as a multiple-dose regimen for the prevention of infectious complications in patients undergoing transrectal needle biopsies of the prostate (TRNBP).

Being tested
Ciprofloxacin single dose, Ciprofloxacin triple dose
Keywords
Prevention of infectious complications, transrectal needle biopsies of the prostate, TRNBP
Medical subject headings
Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ciprofloxacin single doseDrug

    Patients randomized to this regimen will receive a single-dose of ciprofloxacin MR 1000 mg PO approximately 2 to 3 hours prior to the TRNBP. Patients will also receive two doses of matching placebo approximately 24 hours prior to and approximately 24 hours after the TRNBP.

  • Ciprofloxacin triple doseDrug

    Patients randomized to this regimen will receive three doses of ciprofloxacin MR 1000 mg PO. The doses will be approximately 24 hours prior to the TRNBP, approximately 2 to 3 hours prior to the TRNBP, and approximately 24 hours after the TRNBP.

Study groups in NCT00670215
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Ciprofloxacin single dose
Arm 2ExperimentalNot described
Receives: Drug: Ciprofloxacin triple dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bacteriological Response (bacteriuria vs. no bacteriuria)

    Measured: 10-14 days after last dose of study med

Secondary outcomes (2)

  1. Clinical Response (patients without clinical symptoms or signs of bacteriuria vs. patients with clinical symptoms or signs of bacteriuria)

    Measured: 10-14 days after last dose of study med.

  2. Incidence of post-procedure GU tract infections other than bacteriuria

    Measured: any time after the TRNBP

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2008 (estimated)
  2. Study startApr 2004
  3. Study completionOct 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
497 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00670215
Sponsor's protocol ID
100588
Status last verified
Dec 2014
First submitted
29 Apr 2008
Last updated
19 Dec 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ciprofloxacin single dose and Ciprofloxacin triple dose in people with Bacterial Infections, run by Bayer at 51 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Canada, Mexico, Brazil, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bacteriological Response (bacteriuria vs. no bacteriuria) (time frame: 10-14 days after last dose of study med). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00670215.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2014.

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