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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02966457

Acronym

DEHAM

Enrollment

Registered

2016-11-17

Start date

2017-01-31

Completion date

2017-12-31

Last updated

2017-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematological Infection

Keywords

hematological infection, decolonization

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.

Interventions

DRUGColistimethate Sodium

Selective oral intestinal decolonization

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of eradication of ESBL-producing or carbapenem-resistant Enterobacteriaceae, carbapenem-resistant A. baumannii or P. aeruginosa at day 21 post-treatment	21 days

Secondary

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

Countries

Belarus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026