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

Overview

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.

Full Title of Study: “A Randomized Clinical Study of the Decolonization of MDR Gram-negative Bacteria in Patients With Haematological Malignancies”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2017

Interventions

  • Drug: Colistimethate Sodium
    • Selective oral intestinal decolonization

Arms, Groups and Cohorts

  • Experimental: Selective intestinal decolonization
    • Drug: Decolonization with Colistimethate sodium (2 mln I.U. 4x/day PO) for 14 days
  • No Intervention: “Wait and watch” strategy
    • Group without decolonization interventions

Clinical Trial Outcome Measures

Primary Measures

  • Rate of eradication of ESBL-producing or carbapenem-resistant Enterobacteriaceae, carbapenem-resistant A. baumannii or P. aeruginosa at day 21 post-treatment
    • Time Frame: 21 days

Secondary Measures

  • Rate of resistance of isolated on day 21 post-treatment Enterobacteriaceae, A. baumannii, P. aeruginosa to polymyxin antibiotics
    • Time Frame: 21 days

Participating in This Clinical Trial

Inclusion Criteria

1. Microbiologically proven rectal carriage of ESBL-producing Enterobacteriaceae or carbapenem-resistant Enterobacteriaceae, A. baumannii, P. aeruginosa without signs and symptoms of active infection.

2. Patient must give written informed consent to participate in the study. The informed consent can be given by the legal representative if necessary.

Exclusion Criteria

1. Active bacterial, viral, fungal or protozoal infection

2. Women who are pregnant or nursing

3. Antibacterial therapy in previous 10 days

4. Contraindication to the use of one of the study drugs (including known hypersensitivity)

5. Patient already enrolled in another study, or in the present study for a previous episode

6. Psychiatric disorder or unable to understand or to follow the protocol directions

7. Resistance of the primarily isolated colonizing microorganism to polymyxin antibiotics proven by methods of polymerase chain reaction

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
  • Collaborator
    • Belarusian State Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ihar Iskrou, Head of Cell Transplant Division – Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
  • Overall Official(s)
    • Ihar Iskrou, Ph.D., Study Chair, Republican Center of Hematology and Bone Marrow Transplantation

References

Stoma I, Karpov I, Milanovich N, Uss A, Iskrov I. Risk factors for mortality in patients with bloodstream infections during the pre-engraftment period after hematopoietic stem cell transplantation. Blood Res. 2016 Jun;51(2):102-6. doi: 10.5045/br.2016.51.2.102. Epub 2016 Jun 23.

Rieg S, Küpper MF, de With K, Serr A, Bohnert JA, Kern WV. Intestinal decolonization of Enterobacteriaceae producing extended-spectrum β-lactamases (ESBL): a retrospective observational study in patients at risk for infection and a brief review of the literature. BMC Infect Dis. 2015 Oct 28;15:475. doi: 10.1186/s12879-015-1225-0.

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