DRKS00006330进行中（未招募）2 期
Carriage of 3GCREB in patients at risk for relapsing infection: randomizedcontrolled trial of intestinal decolonization with colistin plus rifaximin - Eradicate
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 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. 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
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 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.
研究者
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