EUCTR2014-000180-41-DE进行中（未招募）1 期
Carriage of 3GCREB in patients at risk for relapsing infection: randomized controlled trial of intestinal decolonization with colistin plus rifaximin. - Eradicate
Medical Center - University of Freiburg0 个研究点开始时间: 2015年2月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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. Known status concerning urinary tract colonisation before day 0 of the study. 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 154
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •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 before the end of a required restriction period;
- •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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