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

NCT02966457 | Completed Phase 4 DMC

• 1 other identifier: HEM-3_1
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hematological infection, decolonization

Outcome Measures

Primary Outcomes (1)

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

  21 days

Secondary Outcomes (1)

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

  21 days

Study Arms (2)

Selective intestinal decolonization

EXPERIMENTAL

Drug: Decolonization with Colistimethate sodium (2 mln I.U. 4x/day PO) for 14 days

Drug: Colistimethate Sodium

"Wait and watch" strategy

NO INTERVENTION

Group without decolonization interventions

Interventions

Colistimethate Sodium DRUG

Selective oral intestinal decolonization

Also known as: Colistin

Selective intestinal decolonization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Microbiologically proven rectal carriage of ESBL-producing Enterobacteriaceae or carbapenem-resistant Enterobacteriaceae, A. baumannii, P. aeruginosa without signs and symptoms of active infection.
• Patient must give written informed consent to participate in the study. The informed consent can be given by the legal representative if necessary.

You may not qualify if:

• Active bacterial, viral, fungal or protozoal infection
• Women who are pregnant or nursing
• Antibacterial therapy in previous 10 days
• Contraindication to the use of one of the study drugs (including known hypersensitivity)
• Patient already enrolled in another study, or in the present study for a previous episode
• Psychiatric disorder or unable to understand or to follow the protocol directions
• Resistance of the primarily isolated colonizing microorganism to polymyxin antibiotics proven by methods of polymerase chain reaction

Sponsors & Collaborators

• Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology: lead
• Belarusian State Medical University: collaborator

Study Sites (1)

Republican Center of Hematology and Bone Marrow Transplantation

Minsk, 220045, Belarus

Location

Related Publications (3)

• 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.

  PMID: 27382554 BACKGROUND

• Rieg S, Kupper MF, de With K, Serr A, Bohnert JA, Kern WV. Intestinal decolonization of Enterobacteriaceae producing extended-spectrum beta-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.

  PMID: 26511929 BACKGROUND

• Stoma I, Karpov I, Iskrov I, Krivenko S, Uss A, Vlasenkova S, Lendina I, Cherniak V, Suvorov D. Decolonization of Intestinal Carriage of MDR/XDR Gram-Negative Bacteria with Oral Colistin in Patients with Hematological Malignancies: Results of a Randomized Controlled Trial. Mediterr J Hematol Infect Dis. 2018 May 1;10(1):e2018030. doi: 10.4084/MJHID.2018.030. eCollection 2018.

  PMID: 29755707 DERIVED

MeSH Terms

Interventions

colistinmethanesulfonic acid; Colistin

Intervention Hierarchy (Ancestors)

Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins

Study Officials

• Ihar Iskrou, Ph.D.

  Republican Center of Hematology and Bone Marrow Transplantation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cell Transplant Division

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 17, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 28, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)