CONTROLING INTESTINAL COLONIZATION OF HIGH-RISK PATIENTS WITH EXTENDED- SPECTRUM BETALACTAMASE PRODUCING ENTEROBACTERIACEAE (ESBL-E) – A RANDOMIZED TRIAL (CLEAR) - CLEAR

niversity of Cologne0 个研究点目标入组 47 人开始时间: 2013年9月20日最近更新: 2018年5月14日

试验速览

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•Fecal colonization with ESBL-E, as confirmed by a positive sample (rectal swab or stool sample) obtained within 14 days prior to study enrolment
•Ongoing or scheduled immunosuppression:
•oallogeneic or autologous hematopoietic stem cell transplantation within 14 days after enrolment or
•ochemotherapy with an expected duration of chemotherapy-associated neutropenia of at least 7 days within 14 days after enrolment or
•osolid organ transplantation within 14 days after enrolment or
•oadministration of high-dose corticosteroids or other immunosuppressants for acute rejection of a solid organ transplant or for graft versus host disease after stem cell transplantation
•Age of at least 18 years
•Subject is not legally incapacitated
•Written informed consent from the trial subject has been obtained
•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 37
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Current or scheduled administraton of ESBL-E active antibiotic treatment or prophylaxis after receipt of the most recent sample showing intestinal ESBL-E colonization and within 10 days after randomization
•Planned selective digestive tract decolonization (SDD) within 42 days following randomization
•Known hypersensitivity or allergy to any of the components of the study treatment
•Moderate or severe liver dysfunction at baseline, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than three times the upper limit of normal (ULN), AND a total bilirubin level greater than two times the ULN
•Serum creatinine > 2 x the ULN
•Current pregnancy or nursing period
•Failure to use highly-effective contraceptive methods
•Concurrent participation in another clinical trial with an investigational drug is not permitted, unless the drug under study is related to the treatment of the underlying condition, transplantation or immunosuppression

发起方

niversity of Cologne