A Study of DEcolonization in Patients With HAematological Malignancies (DEHAM) (DEHAM)
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|ClinicalTrials.gov Identifier: NCT02966457|
Recruitment Status : Completed
First Posted : November 17, 2016
Last Update Posted : December 28, 2017
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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 ]
- Rate of resistance of isolated on day 21 post-treatment Enterobacteriaceae, A. baumannii, P. aeruginosa to polymyxin antibiotics [ Time Frame: 21 days ]
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
|Republican Center of Hematology and Bone Marrow Transplantation|
|Minsk, Belarus, 220045|
|Study Chair:||Ihar Iskrou, Ph.D.||Republican Center of Hematology and Bone Marrow Transplantation|