A Study of DEcolonization in Patients With HAematological Malignancies (DEHAM)
Status:
Completed
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
MDR (multidrug resistant) gram-negative bacteria have emerged as an important cause of
bloodstream infection in hospitalized patients, especially in immunocompromised hosts. It was
previously shown, that intestinal colonization with extended-spectrum β-lactamases
(ESBL)-producing or carbapenem-resistant Enterobacteriaceae, carbapenem-resistant A.
baumannii and P. aeruginosa) is a clinical predictor of bloodstream infections in patients
with haematological malignancies and/or haematopoietic stem cell transplantation [Stoma I. et
al., 2016].
To the investigators knowledge no randomized, placebo-controlled clinical trial has been
performed to study the efficacy and safety of selective intestinal decolonization strategies
in high-risk patients with haematological malignancies. Possible decolonization of MDR
gram-negative bacteria in haematological patients could be important for the patient by
reducing the risk of infection and for the community by reducing the risk of transmission.
The purpose of the proposed study is to assess the efficacy and safety of selective
intestinal decolonization of MDR gram-negative bacteria with oral administration of
Colistimethate sodium in high risk patients with haematological malignancies.
Phase:
Phase 4
Details
Lead Sponsor:
Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology Minsk State Clinical Hospital No 9