Trial document




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  DRKS00006330

Trial Description

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Title

Carriage of 3GCREB in patients at risk for relapsing infection: randomized
controlled trial of intestinal decolonization with colistin plus rifaximin

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Trial Acronym

Eradicate

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URL of the Trial

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Brief Summary in Lay Language

decolonization treatment with oral non-absorbable drugs to see if the treatment is superior to watch & wait in eradicating bacteria from the intestinal tract and prevent infection

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Brief Summary in Scientific Language

Decolonization treatment with oral non-absorbable drugs to compare if it is superior to watch & wait in eradicating 3GCREB from the intestinal tract and prevent infection

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006330
  •   2015/05/18
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  •   yes
  •   Approved
  •   44/15 (FF-MC), Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   2014-000180-41 
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Health Condition or Problem studied

  •   A04.9 -  Bacterial intestinal infection, unspecified
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Interventions/Observational Groups

  •   Patients will be treated with colistin ( 4 x 2 million units/day) and rifaximin (2 x 400 mg/day) for 3 weeks.
  •   Patients with no active drug treatment (watch & wait, control group).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   II
  •   Yes
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Primary Outcome

3GCREB eradication defined as: no evidence for colonization with 3GCREB by preferably rectal swab and/or stool cultures performed at end of treatment visit (=visit 3) and at 1-2 weeks after end of treatment visit (=visit 4).

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Secondary Outcome

- early (rapid) 3GCREB decolonization (days 8-12 after treatment initiation=visit 2);
- late (sustained) 3GCREB decolonization (week 9 after end of treatment visit =visit 5);
- any infection which requires antibiotic therapy
- infection originating from gastrointestinal tract microflora (including urinary tract infection) which requires antibiotic therapy;
- intestinal carriage of colistin- and rifaximin-resistant 3GCREB;

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/11/16
  •   174
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Written informed consent obtained according to international guidelines and local laws;
2. Male or female patients aged 18 or older;
3.Patients with at least two episodes of infection
-during the last 12 months,
-each time requiring specific antibiotic therapy and
-due to the same species of 3GCREB (ESBL and/or AmpC enterobacteria) but not necessarily with identical susceptibility test results.
A second infection WITHOUT microbiological documentation can be accepted if
-it can be considered as relapsing infection with the same clinical focus based on clinical judgement
-and there has been no other relevant pathogen for this episode
-and the episode required antibiotic treatment considered adequate and clinically effective
4. Patients with current colonization with the same species of 3GCREB as in (3)
- on two occasions within three weeks before day 0 of the study (i.e. day -21 to -1).
- proven by two cultures taken at least one week apart from each other, with the second culture taken within one week before day 0 of the study (i.e. day -7 to -1)
- with the first culture taken from any site (e.g. sputum, wound,urinary tract, rectal swab, stool)*
- and the second being a rectal swab, alternatively stool**
- absence of antibiotic therapy, except
- if treatment stop is planned before day 0 of the trial
- short-term therapy for uncomplicated urinary tract infection (oral fosfomycin, norfloxacin, trimethoprim or trimethoprim-sulfamethoxazole for 3 days or less, or nitrofurantoin for no more than 5 days);
5. Specific inclusion criteria for patients with a history of recurrent urinary tract infections: Result of a current urine culture (done 3 weeks before day 0 of the study) has to be on hand. Result of urine culture which was routinely performed during medical care of a patient will be accepted;
6. Ability to understand the nature of the trial and the trial related procedures and to comply with them;

* Result of culture which was routinely performed during medical care of a patient will be accepted;
** To obtain at least one baseline culture sample for analysis in the Microbiology Reference Center (see
section 7.6.11), results of cultures routinely performed cannot be accepted

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Exclusion Criteria

1. Patients with rapidly fatal underlying disease (i.e. McCabe category 3);
2. Patients with severe diarrhea (defined as >5 bowel movements per day with loose stools) in the last three days;
3. Patients with severe nausea/vomiting;
4. Patients with inability to swallow;
5. Patients who received recent (last 3 weeks) treatment with oral colistin and/or rifaximin;
6. Patients with expected low compliance with drug regimen;
7. Simultaneous participation in other interventional trials which could interfere with this trial and/or participation within the last 30
days before the start of this trial (except for registry and diagnostic trials);
8. Patients with contraindications to the study drugs such as known intolerance of the study drugs (including other rifamycin derivatives like rifampin/rifampicin, rifabutin and rifapentine);
9. Co-medication with ibrutinib (recently approved tyrosine kinase inhibitor for treatment of patients with B cell lymphomas);
10. Known or persistent abuse of medication, drugs or alcohol;
11. Persons who are in a relationship of dependence/employment with the sponsor or the investigator;

Specific exclusion criteria for female patients:
1. Current or planned pregnancy, nursing period;
2. Failure to use one of the following safe methods of contraception: female condoms, diaphragm or coil, each used in combination
with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception.

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Mr.  Prof. Dr.  Winfried  Kern 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Abteilung Infektiologie
    • Mr.  Dr.  Marc Fabian  Küpper 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting stopped after recruiting started
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.