Hematological InfectionPhase 4DEHAMNCT02966457
A Study of DEcolonization in Patients With HAematological Malignancies (DEHAM)
A Phase 4 study testing Colistimethate Sodium in people with Hematological Infection, run by Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology at 1 site in Belarus.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Infection
- What is being tested?
- Colistimethate Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBelarus
- Study dates
- Jan 2017to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belarus1 site
Republican Center of Hematology and Bone Marrow Transplantation
Minsk, 220045
About this study
Official title: A Randomized Clinical Study of the Decolonization of MDR Gram-negative Bacteria in Patients With Haematological Malignancies
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.
- Conditions
- Hematological Infection
- Being tested
- Colistimethate Sodium
- Keywords
- hematological infection, decolonization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colistimethate SodiumDrug
Also called Colistin
Selective oral intestinal decolonization
| Study group | Role | What they receive |
|---|---|---|
| Selective intestinal decolonization | Experimental | Drug: Decolonization with Colistimethate sodium (2 mln I.U. 4x/day PO) for 14 days Receives: Drug: Colistimethate Sodium |
| "Wait and watch" strategy | No intervention | Group without decolonization interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of eradication of ESBL-producing or carbapenem-resistant Enterobacteriaceae, carbapenem-resistant A. baumannii or P. aeruginosa at day 21 post-treatment
Measured: 21 days
Secondary outcomes (1)
Rate of resistance of isolated on day 21 post-treatment Enterobacteriaceae, A. baumannii, P. aeruginosa to polymyxin antibiotics
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hematological InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
- Sponsor type
- Other government
- Collaborators
- Belarusian State Medical University
- Responsible party
- Principal investigator, Ihar Iskrou, Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
- Investigators
- Ihar Iskrou, Ph.D., Study chair, Republican Center of Hematology and Bone Marrow Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966457
- Sponsor's protocol ID
- HEM-3_1
- Acronym
- DEHAM
- Status last verified
- Dec 2017
- First submitted
- 15 Nov 2016
- Last updated
- 28 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27382554Rieg 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.
PubMed 26511929Stoma 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.
PubMed 29755707
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Study of the Decolonization of MDR Gram-negative Bacteria in Patients With Haematological Malignancies
- ClinicalTrials.gov ID
- NCT02966457
- Acronym / sponsor ID
- DEHAM / HEM-3_1
- Conditions
- Hematological Infection
- Keywords
- hematological infection, decolonization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Minsk Scientific-Practical Center for Surgery, Transplantation and HematologyOther government
- Collaborators
- Belarusian State Medical University
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selective intestinal decolonization | Experimental | Drug: Colistimethate SodiumDrug: Decolonization with Colistimethate sodium (2 mln I.U. 4x/day PO) for 14 days |
| "Wait and watch" strategy | No intervention | –Group without decolonization interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colistimethate SodiumAlso: ColistinSelective oral intestinal decolonization | Drug | Selective intestinal decolonization |
Primary outcome
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
1 secondary outcome
Rate of resistance of isolated on day 21 post-treatment Enterobacteriaceae, A. baumannii, P. aeruginosa to polymyxin antibiotics
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Background: PubMed 27382554Stoma 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.
- Background: PubMed 26511929Rieg 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.
- Derived from this study: PubMed 29755707Stoma 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ihar Iskrou, Ph.D. study chair
Republican Center of Hematology and Bone Marrow Transplantation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colistimethate Sodium in people with Hematological Infection, run by Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02966457, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2017.