A Study of DEcolonization in Patients With HAematological Malignancies (DEHAM)
NCT ID: NCT02966457
Last Updated: 2017-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
62 participants
INTERVENTIONAL
2017-01-31
2017-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Selective intestinal decolonization
Drug: Decolonization with Colistimethate sodium (2 mln I.U. 4x/day PO) for 14 days
Colistimethate Sodium
Selective oral intestinal decolonization
"Wait and watch" strategy
Group without decolonization interventions
No interventions assigned to this group
Interventions
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Colistimethate Sodium
Selective oral intestinal decolonization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Belarusian State Medical University
OTHER
Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
OTHER_GOV
Responsible Party
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Ihar Iskrou
Head of Cell Transplant Division
Principal Investigators
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Ihar Iskrou, Ph.D.
Role: STUDY_CHAIR
Republican Center of Hematology and Bone Marrow Transplantation
Locations
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Republican Center of Hematology and Bone Marrow Transplantation
Minsk, , Belarus
Countries
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References
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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, 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.
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.
Other Identifiers
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HEM-3_1
Identifier Type: -
Identifier Source: org_study_id