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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02966457
Recruitment Status : Completed
First Posted : November 17, 2016
Last Update Posted : December 28, 2017
Sponsor:
Collaborator:
Belarusian State Medical University
Information provided by (Responsible Party):
Ihar Iskrou, Minsk State Clinical Hospital No 9

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.


Condition or disease Intervention/treatment Phase
Hematological Infection Drug: Colistimethate Sodium Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Clinical Study of the Decolonization of MDR Gram-negative Bacteria in Patients With Haematological Malignancies
Actual Study Start Date : January 2017
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Selective intestinal decolonization
Drug: Decolonization with Colistimethate sodium (2 mln I.U. 4x/day PO) for 14 days
Drug: Colistimethate Sodium
Selective oral intestinal decolonization
Other Name: Colistin

No Intervention: "Wait and watch" strategy
Group without decolonization interventions



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Rate of resistance of isolated on day 21 post-treatment Enterobacteriaceae, A. baumannii, P. aeruginosa to polymyxin antibiotics [ Time Frame: 21 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966457


Locations
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Belarus
Republican Center of Hematology and Bone Marrow Transplantation
Minsk, Belarus, 220045
Sponsors and Collaborators
Minsk State Clinical Hospital No 9
Belarusian State Medical University
Investigators
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Study Chair: Ihar Iskrou, Ph.D. Republican Center of Hematology and Bone Marrow Transplantation

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ihar Iskrou, Head of Cell Transplant Division, Minsk State Clinical Hospital No 9
ClinicalTrials.gov Identifier: NCT02966457     History of Changes
Other Study ID Numbers: HEM-3_1
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ihar Iskrou, Minsk State Clinical Hospital No 9:
hematological infection, decolonization
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases
Colistin
Anti-Bacterial Agents
Anti-Infective Agents