Controling Intestinal Colonization With Extended Spectrum ß-Lactamase Producing Enterobacteriaceae ESBL-E

• Status: Terminated
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Rapid and rational health-care interventions are of great importance to efficiently combat the emergence of resistant and virulent bacteria. In recent years, spread of ESBL-E on a global level has been observed.

For ESBL-E, effective eradication regimens are not yet available. The current study therefore aims to assess a new approach to ESBL-E eradication. To avoid administration of the eradication regimen to patients at low risk of subsequent BSI with ESBL-E, the study population will be restricted to immunocompromised high-risk patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maria J.G.T. Vehreschild
• Treatments: Colistin; Fosfomycin; Gentamicins

Criteria

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:

• allogeneic or autologous hematopoietic stem cell transplantation within 14 days after enrollment or

• chemotherapy with an expected duration of chemotherapy-associated neutropenia of at least 7 days within 14 days after enrollment or

• solid organ transplantation within 14 days after enrollment or

• administration 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

Exclusion Criteria:

• Current or scheduled administration of ESBL-E active antibiotic treatment after receipt of the most recent sample showing intestinal ESBL-E colonization and within 10 days after randomization

• Planned selective digestive tract decolonization 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 upper limit of the ULN

• Inability to take oral medication

• 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 or a transplantation

• Current pregnancy or nursing period

• In female study participants, failure to use highly-effective contraceptive methods. The following contraceptive methods with a Pearl Index lower than 1% are regarded as highly-effective:

• Oral hormonal contraception ('pill')

• Dermal hormonal contraception

• Vaginal hormonal contraception (NuvaRing®)

• Contraceptive plaster

• Long-acting injectable contraceptives

• Implants that release progesterone (Implanon®)

• Tubal ligation (female sterilization)

• Intrauterine devices that release hormones (hormone spiral)

• Double barrier methods This means that the following are not regarded as safe:

condom plus spermicide, simple barrier methods (vaginal pessaries, condom, female condoms), copper spirals, the rhythm method, basal temperature method, and the withdrawal method (coitus interruptus).

• Patient has any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the patient participating in the study, would make it unlikely for the patient to complete the study, or would confound the results of the study

• Persons with any kind of dependency on the investigator or employed by the sponsor or investigator

• Persons held in an institution by legal or official order