NCT02966457

A Study of DEcolonization in Patients With HAematological Malignancies (DEHAM)

A Randomized Clinical Study of the Decolonization of MDR Gram-negative Bacteria in Patients With Haematological Malignancies

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematological Infection

Interventions

Type	Name	Description
DRUG	Colistimethate Sodium	Selective oral intestinal decolonization

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-11-17
• Last updated: 2017-12-28

Locations

1 site across 1 country: Belarus