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

2016-11-18 12:53:22 | BioPortfolio

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Conditions

Hematological Infection

Intervention

Colistimethate Sodium

Location

Republican Center of Hematology and Bone Marrow Transplantation
Minsk
Belarus
220045

Status

Not yet recruiting

Source

Minsk State Clinical Hospital No 9

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-11-18T12:53:22-0500

Clinical Trials [1116 Associated Clinical Trials listed on BioPortfolio]

Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium

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Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium (PROMIS-2)

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Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli

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PubMed Articles [8291 Associated PubMed Articles listed on BioPortfolio]

Neutrophil Gelatinase-associated Lipocalin as a Predictor of Acute Kidney Injury in Patients during Treatment with Colistimethate Sodium.

The emergence of multidrug-resistant, Gram-negative bacteria has resulted in reconsideration of colistimethate sodium (CMS) as a last resort for treatment of such infections. However, acute kidney inj...

Influence of diluent volume of colistimethate sodium on aerosol characteristics and pharmacokinetics in ventilator-associated pneumonia caused by MDR bacteria.

Nebulized colistimethate sodium (CMS) can be used to treat ventilator-associated pneumonia caused by MDR bacteria. The influence of the diluent volume of CMS on aerosol delivery has never been studied...

Hepatic and extra-hepatic manifestations of hepatitis E virus infection.

All patients with elevated transaminases in France should be tested for HEV infection. HEV can cause severe hepatitis, in particular in patients with chronic liver disease, pregnant women and the elde...

The p.Ser267Phe variant of sodium taurocholate cotransporting polypeptide (NTCP) supports HBV infection with a low efficiency.

Sodium taurocholate cotransporting polypeptide (NTCP) is a functional receptor for human hepatitis B virus (HBV) and its satellite virus Hepatitis D virus (HDV). Physiologically, NTCP is responsible f...

What the internist should know about stem cell transplant in the elderly patient.

Most hematological malignancies are increasing in frequency with age. Allogeneic hematopoietic cell transplantation (allo-HCT) is a potentially curative therapeutic option for patients with malignant ...

Medical and Biotech [MESH] Definitions

Sodium or sodium compounds used in foods or as a food. The most frequently used compounds are sodium chloride or sodium glutamate.

A voltage-gated sodium channel subtype that mediates the sodium ion PERMEABILITY of CARDIOMYOCYTES. Defects in the SCN5A gene, which codes for the alpha subunit of this sodium channel, are associated with a variety of CARDIAC DISEASES that result from loss of sodium channel function.

Stable sodium atoms that have the same atomic number as the element sodium, but differ in atomic weight. Na-23 is a stable sodium isotope.

A family of membrane proteins that selectively conduct SODIUM ions due to changes in the TRANSMEMBRANE POTENTIAL DIFFERENCE. They typically have a multimeric structure with a core alpha subunit that defines the sodium channel subtype and several beta subunits that modulate sodium channel activity.

Cell membrane glycoproteins selective for sodium ions. Fast sodium current is associated with the action potential in neural membranes.

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