Study to evaluate treatment for colonization with certain multidrug-resistant bacteria in the gut in patients with a compromised immune system.

Phase 1

• Conditions: Immunocompromised patients at high risk of bloodstream infections with colonizing bacteria.; MedDRA version: 16.1Level: LLTClassification code 10066481Term: Hematological malignancySystem Organ Class: 100000004864; MedDRA version: 16.1Level: LLTClassification code 10067862Term: Allogeneic stem cell transplantationSystem Organ Class: 100000004865; MedDRA version: 16.1Level: LLTClassification code 10054990Term: Immunodeficiency secondary to organ transplantationSystem Organ Class: 100000004870; MedDRA version: 16.1Level: LLTClassification code 10021458Term: Immunodeficiency secondary to transplantation chemotherapySystem Organ Class: 100000004870; MedDRA version: 16.1Level: LLTClassification code 10021452Term: Immunodeficiency secondary to chemotherapy (excl corticosteroids)System Organ Class: 100000004870; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-003048-21-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-20
• Last Update Posted: 14 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

•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

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified