Hematological Infection Clinical Trial
— DEHAMOfficial title:
A Randomized Clinical Study of the Decolonization of MDR Gram-negative Bacteria in Patients With Haematological Malignancies
| Verified date | December 2017 |
| Source | Minsk State Clinical Hospital No 9 |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 62 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Belarus | Republican Center of Hematology and Bone Marrow Transplantation | Minsk |
| Lead Sponsor | Collaborator |
|---|---|
| Minsk State Clinical Hospital No 9 | Belarusian state medical university |
Belarus,
Rieg S, Küpper MF, de With K, Serr A, Bohnert JA, Kern WV. Intestinal decolonization of Enterobacteriaceae producing extended-spectrum ß-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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Rate of resistance of isolated on day 21 post-treatment Enterobacteriaceae, A. baumannii, P. aeruginosa to polymyxin antibiotics | 21 days |