Completed

NCT Number: NCT02966457

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

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.

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Key information

Conditions

Hematological Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Republican Center of Hematology and Bone Marrow Transplantation

Minsk, 220045, Belarus

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

colistimethate sodium

Drug

Selective oral intestinal decolonization

Other names: Colistin

Primary outcomes

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 outcomes

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

Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

Other Gov

Collaborators

Belarusian State Medical University

Registry information

Official study title

A Randomized Clinical Study of the Decolonization of MDR Gram-negative Bacteria in Patients With Haematological Malignancies

Acronym: DEHAM

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Nov 17, 2016
Registry last updated: Dec 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.