E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prophylaxis of bacterial infections following prostate biopsies |
Antibiotikaprofylax vid prostatabiopsi |
|
E.1.1.1 | Medical condition in easily understood language |
Prophylaxis of bacterial infections following prostate biopsies |
Antibiotika vid prostatabiopsi |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the effect between Fosfomycin and Ciprofloxacin when being
used as antibiotic prophylaxis for prostate biopsy |
Jämförelse av effekten av Fosfomycin och Ciproflaxacin vid
prostatabiopsi |
|
E.2.2 | Secondary objectives of the trial |
Establish the frequency of infektions in high- and low risk patients
Investigate if the rectal flora is affected by Fosfomycin or ciprofloxacin
Mortality
Inpatient Days
Risk factors |
Att undersöka infektionsfrekvensen hos hög- och lågriskpatienter
Undersöka om rektalfloran påverkas av fosfomycin och ciprofloxacin
Mortalitet
Vårdtid
Riskfaktorer |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Indication for prostate biopsy
Informed consent
No exclusion criteria |
Indikation för prostatabiopsi
Informerat samtycke
Inga exclusionskriterier |
|
E.4 | Principal exclusion criteria |
Allergy to Fosfomycin or Ciprofloxacin
Use of Tizanidine
Hemodialysis or severe renal failure |
Allergi mot Fosfomycin eller ciprofloxacin
Användning av Tizanidine
Hemodialys eller svår njursvikt |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Submission to inpatient care because of sepsis within two weeks after
prostate biopsy |
Inläggning på sjukhus pga sepsis inom 2 veckor efter prostatabiopsi |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
14 Days after the biopsy. The endpoint will be evaluated 6 months after
the cancellation of the trial |
14 dagar efter bipsin. Utfallsvariabeln kommer att undersökas ca 6 mån
efter studiens avslut |
|
E.5.2 | Secondary end point(s) |
Prescribed antibiotics for UTI within 30 Days after the biopsy
* Submission to hospital, same as thje primary endpoint, but exclusding
patients with antibiotic resistance to Fosfomycin or Ciprofloxacin
* Analysis of urine Cultures after infections following the biopsy
* Inpatient care regardless of cause within 14 Days after the biopsy
* Mortality <90 Days
* Bacteriological carachteristics on urine cultures
* Bacteriological carachtereistics on rectal swabs Before and after the
biopsy (4 weeks after)
* Number of inpatient Days
* Daily doses of antibiotics
* Risk factors for infection based on baseline data |
• Förskriven urinvägsantibiotika inom 30 dagar från biopsitillfälle.
• Inlagd på sjukhus med diagnos som överensstämmer med
urinvägsinfektion eller sepsis, inom 14 dagar efter prostatabiopsi, analys
av patienter utan resistens mot given antibiotika.
• Positiv urinodling eller positiv blododling med urinvägspatogen inom
30 dagar efter biopsi.
• Sjukhusinläggning oavsett orsak 14 dagar efter biopsi.
• Mortalitet inom 90 dagar efter biopsi.
• Bakteriologisk karaktäristika på fallens blod- respektive urinodlingar.
• Karakterisering av rektal bakterieflora före, samt två till fyra veckor
efter biopsi (genomförs på universitetssjukhuset i Örebro på prover från
orter som genomför odlingar).
• Vårdtid på sjukhus.
• Antal dygnsdoser antibiotika.
• Riskfaktorer för infektion, analys av baslinjevariabler samt multipla
biopsiomgångar. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
14 Days to 90 days after the biopsy. These endpoint will be evaluated 6 months after
the cancellation of the trial |
14 dagar till 90 dagar efter biopsin. Utfallsvariablerna kommer att undersökas ca 6 mån
efter studiens avslut |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The trial is ended when person nr 3448 is included. |
Studien stänger när patient nr 3448 har includerats |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |