Detection of Bloodstream Pathogens in Hematological Malignancies
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|ClinicalTrials.gov Identifier: NCT03896880|
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : June 19, 2019
- To identify the common bacterial and fungal species causing fungemia and bacteremia in hematological malignancies.
- To identify sensitivity pattern for causative microbes.
- Compare culture on ordinary media with Vitek2 (automated microbial identification system) and multiplex polymerase chain reaction (PCR )
|Condition or disease||Intervention/treatment|
|Bloodstream Infection||Diagnostic Test: blood culture Other: Anti fungal susceptibility testing or antibiotic susceptibility testing Other: phenotypic identification methods of the isolated organism by Vitek2 (BioMerieux,France) Other: Identification of the isolated organism by multiplex PCR|
|Study Type :||Observational|
|Estimated Enrollment :||139 participants|
|Official Title:||Detection of Bloodstream Pathogens in Hematological Malignancies|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||December 2020|
blood culture positive
hematological malignancy patients with positive blood culture
Diagnostic Test: blood culture
During the febrile episode, two blood samples per patient will draw from two separate sites including central venous catheter if present and directly injected to Bact/Alert® bottles and incubated in Bact/ALERT system instrument (bioMérieux Diagnostics, Lyon, France).
A-Identification of microorganisms including:
B-Identification of the bacterial organism
Pure colonies of isolated microorganisms were identified by:
Morphology on agar,Gram stain film was made from the growth to identify morphology of the organism ,Biochemical tests
C-For fungi isolate the following will perform:
Other: Anti fungal susceptibility testing or antibiotic susceptibility testing
isolation of microbes from positive blood culture and anti fungal susceptibility testing or antibiotic susceptibility testing according to isolated microbes by disc diffusion method and Vitek2
Other Name: antimicrobial susceptibility testing
Other: phenotypic identification methods of the isolated organism by Vitek2 (BioMerieux,France)
The VITEK 2 is an automated microbial identification system that utilizing growth-based technology. With its colorimetric reagent cards, the VITEK 2 offers a state of the art technology platform for phenotypic identification methods.
Other Name: Vitek2 (BioMerieux,France)
Other: Identification of the isolated organism by multiplex PCR
FilmArray blood culture identification (BCID) is automated multiplex PCR assay, the FilmArray blood culture identification which directly identifies common pathogens, including 7 genera/ species of Gram-positive bacteria, 10 genera/species of Gram-negative bacteria, and 5 species of Candida (as well as 3 resistance determinants) in the positive blood culture bottles. The assay requires about 2 min of hands-on sample processing time and 1 h of instrument time (which includes DNA isolation, amplification, and detection).
- identify pathogens in positive blood culture in hematological malignancies patients [ Time Frame: 1 year ]Examine blood culture to diagnose different species of pathogens including bacteria and fungi responsible for bloodstream infection in hematological malignancies patients.
- Antimicrobial susceptibility testing and drug resistance [ Time Frame: 1 year ]performance of antimicrobial susceptibility testing (anti fungal susceptibility testing or antibiotic susceptibility testing )of significant bacterial isolates. The goals of testing are to detect possible drug resistance in common pathogens and to assure susceptibility to drugs of choice for particular infections.
- prevalence of bloodstream infection in hematological malignancy patients [ Time Frame: 1 year ]prevalence of both bacteremia and fungemia in hematological malignancies using blood culture
- Time from blood collection to pathogen identification [ Time Frame: 1 year ]The hypothesis is that faster identification will lead to faster action.
- In-hospital mortality. [ Time Frame: 1 year ]Faster treatment is associated with reduced mortality
- Rapid diagnosis of bloodstream infections [ Time Frame: 1 year ]Compare different methods for rapid identification of blood culture positive results including Vitek2 (BioMerieux,France) and multiplex PCR
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896880
|Contact: Marwa M mohammed, firstname.lastname@example.org|
|Contact: Amal M Hosni, email@example.com|
|Study Director:||Mohamed Z Abo krisha, professor||Assiut University|