Bloodstream InfectionNCT03896880
Detection of Bloodstream Pathogens in Hematological Malignancies
An observational study of Bloodstream Infection, run by Assiut University at 1 site in Egypt.
Trial summary
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 ) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bloodstream Infection
- What is being tested?
- blood culture, Anti fungal susceptibility testing or antibiotic susceptibility testing and phenotypic identification methods of the isolated organism by Vitek2 (BioMerieux,France)
- How many people
- 139 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 May 2022
- Phase
- Observational
- 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
Study population: hematological malignancy patients with fever
Who may be able to join
- hematological malignancy patients on chemotherapy associated with fever
Who cannot join
- Age below 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
- 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 )
Read the detailed description
Sepsis is a global health problem and an estimated 17 million cases of sepsis occur each year in the world .The early initiation of appropriate antibiotic therapy is determinant for the prognosis and survival of patients with bloodstream infections . Infections in patients suffering from hematological malignancies are a frequent problem, leading to higher mortality and morbidity, increased costs of health care and prolonged duration of hospitalization. Common among these infections are those involving the bloodstream. In febrile neutropenic patients, the attack rate of bloodstream infection was reported to be between 11 and 38% . Hematological malignancies by themselves or by their therapeutic strategies, put patients at risk for infections. Wide use of antibiotics and prophylactic agents in such patients has led to the development of resistance. The general term fungemia describes the presence of a fungal species in the blood while term bacteremia describes the presence of bacterial species in the blood A positive culture may indicate a widespread infection or commonly, the infection of an intravenous catheter .Fungal microbes are abundant in nature and are frequent colonizers on human mucosal surfaces. However, under conditions of impaired immune responses or a break in host barriers, fungi are able to invade normally sterile areas of the human body, where they can cause severe infections that are difficult to recognize and treat and are often ultimately lethal .Indeed, recent epidemiological data show that invasive fungal infections (IFIs) are frequently encountered in clinical practice, with the most common offenders, being Candida spp. and Aspergillus spp. In order to effectively eliminate these infections, early diagnosis and species identification are of paramount importance. Traditional diagnostic methods such as blood culture is still considered the gold standard .Indeed ,novel molecular and non molecular techniques have been developed and currently under clinical evaluation . 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. The application of the multiplex polymerase chain reaction PCR method in the diagnosis of bloodstream infections is designed to reduce the time for identification of the microorganisms grown from the positive samples to 24-48 hours, as pathogens are identified directly from a positive blood sample
- Conditions
- Bloodstream Infection
- Being tested
- blood culture, Anti fungal susceptibility testing or antibiotic susceptibility testing, phenotypic identification methods of the isolated organism by Vitek2 (BioMerieux,France), Identification of the isolated organism by multiplex PCR
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood cultureDiagnostic test
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:
- Isolation of microorganisms:
- Blood culture samples with positive signals will be cultured on blood agar, chocolate agar , MacConkeys agar and Sabouraud dextrose agar (SDA) plates.
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:
- Microscopic examination of Lactophenol cotton blue (LCB) wet mounts.
- Culture on Brilliance Candida differential agar
Anti fungal susceptibility testing or antibiotic susceptibility testingOther
Also called antimicrobial 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
phenotypic identification methods of the isolated organism by Vitek2 (BioMerieux,France)Other
Also called 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.
Identification of the isolated organism by multiplex PCROther
Also called FilmArray blood culture identification (BCID), 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).
| Study group | Role | What they receive |
|---|---|---|
| blood culture positive | hematological malignancy patients with positive blood culture Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
identify pathogens in positive blood culture in hematological malignancies patients
Examine blood culture to diagnose different species of pathogens including bacteria and fungi responsible for bloodstream infection in hematological malignancies patients.
Measured: 1 year
Antimicrobial susceptibility testing and drug resistance
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.
Measured: 1 year
prevalence of bloodstream infection in hematological malignancy patients
prevalence of both bacteremia and fungemia in hematological malignancies using blood culture
Measured: 1 year
Time from blood collection to pathogen identification
The hypothesis is that faster identification will lead to faster action.
Measured: 1 year
Secondary outcomes (2)
In-hospital mortality.
Faster treatment is associated with reduced mortality
Measured: 1 year
Rapid diagnosis of bloodstream infections
Compare different methods for rapid identification of blood culture positive results including Vitek2 (BioMerieux,France) and multiplex PCR
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 Jan 2020
- Primary completion28 Feb 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bloodstream InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohammed Tolba, Assiut University
- Investigators
- Mohamed Z Abo krisha, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896880
- Sponsor's protocol ID
- Cancer bloodstream infection
- Status last verified
- May 2023
- First submitted
- 27 Mar 2019
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Salomao R, Diament D, Rigatto O, Gomes B, Silva E, Carvalho NB, Machado FR. Guidelines for the treatment of severe sepsis and septic shock - management of the infectious agent - source control and antimicrobial treatment. Rev Bras Ter Intensiva. 2011 Jun;23(2):145-57. English, Portuguese.
PubMed 25299714Gedik H, Simsek F, Kanturk A, Yildirmak T, Arica D, Aydin D, Demirel N, Yokus O. Bloodstream infections in patients with hematological malignancies: which is more fatal - cancer or resistant pathogens? Ther Clin Risk Manag. 2014 Sep 17;10:743-52. doi: 10.2147/TCRM.S68450. eCollection 2014.
PubMed 25258539Yadegarynia D, Tarrand J, Raad I, Rolston K. Current spectrum of bacterial infections in patients with cancer. Clin Infect Dis. 2003 Oct 15;37(8):1144-5. doi: 10.1086/378305. No abstract available.
PubMed 14523785Brown GD, Denning DW, Gow NA, Levitz SM, Netea MG, White TC. Hidden killers: human fungal infections. Sci Transl Med. 2012 Dec 19;4(165):165rv13. doi: 10.1126/scitranslmed.3004404.
PubMed 23253612
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Bloodstream Pathogens in Hematological Malignancies
- ClinicalTrials.gov ID
- NCT03896880
- Acronym / sponsor ID
- Cancer bloodstream infection
- Conditions
- Bloodstream Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 1 Apr 2019 (actual)
- 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.
- 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 )
Detailed description
Sepsis is a global health problem and an estimated 17 million cases of sepsis occur each year in the world .The early initiation of appropriate antibiotic therapy is determinant for the prognosis and survival of patients with bloodstream infections . Infections in patients suffering from hematological malignancies are a frequent problem, leading to higher mortality and morbidity, increased costs of health care and prolonged duration of hospitalization. Common among these infections are those involving the bloodstream. In febrile neutropenic patients, the attack rate of bloodstream infection was reported to be between 11 and 38% . Hematological malignancies by themselves or by their therapeutic strategies, put patients at risk for infections. Wide use of antibiotics and prophylactic agents in such patients has led to the development of resistance. The general term fungemia describes the presence of a fungal species in the blood while term bacteremia describes the presence of bacterial species in the blood A positive culture may indicate a widespread infection or commonly, the infection of an intravenous catheter .Fungal microbes are abundant in nature and are frequent colonizers on human mucosal surfaces. However, under conditions of impaired immune responses or a break in host barriers, fungi are able to invade normally sterile areas of the human body, where they can cause severe infections that are difficult to recognize and treat and are often ultimately lethal .Indeed, recent epidemiological data show that invasive fungal infections (IFIs) are frequently encountered in clinical practice, with the most common offenders, being Candida spp. and Aspergillus spp. In order to effectively eliminate these infections, early diagnosis and species identification are of paramount importance. Traditional diagnostic methods such as blood culture is still considered the gold standard .Indeed ,novel molecular and non molecular techniques have been developed and currently under clinical evaluation . 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. The application of the multiplex polymerase chain reaction PCR method in the diagnosis of bloodstream infections is designed to reduce the time for identification of the microorganisms grown from the positive samples to 24-48 hours, as pathogens are identified directly from a positive blood sample
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood culture positive | – | 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 PCRhematological malignancy patients with positive blood culture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hematological malignancy patients with fever
Key inclusion criteria (1 listed)
- hematological malignancy patients on chemotherapy associated with fever
Key exclusion criteria (1 listed)
- Age below 18 years old
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 |
|---|---|---|
| blood cultureDuring 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: 1. Isolation of microorganisms: 2. Blood culture samples with positive signals will be cultured on blood agar, chocolate agar , MacConkeys agar and Sabouraud dextrose agar (SDA) plates. 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: 1. Microscopic examination of Lactophenol cotton blue (LCB) wet mounts. 2. Culture on Brilliance Candida differential agar | Diagnostic test | blood culture positive |
| Anti fungal susceptibility testing or antibiotic susceptibility testingAlso: antimicrobial susceptibility testingisolation 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 | blood culture positive |
| phenotypic identification methods of the isolated organism by Vitek2 (BioMerieux,France)Also: 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 | blood culture positive |
| Identification of the isolated organism by multiplex PCRAlso: FilmArray blood culture identification (BCID), multiplex PCRFilmArray 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). | Other | blood culture positive |
Primary outcome
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.
2 secondary outcomes
In-hospital mortality.
Time frame: 1 year
Rapid diagnosis of bloodstream infections
Time frame: 1 year
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 16 May 2023.
- Background: PubMed 25299714Salomao R, Diament D, Rigatto O, Gomes B, Silva E, Carvalho NB, Machado FR. Guidelines for the treatment of severe sepsis and septic shock - management of the infectious agent - source control and antimicrobial treatment. Rev Bras Ter Intensiva. 2011 Jun;23(2):145-57. English, Portuguese.
- Background: PubMed 25258539Gedik H, Simsek F, Kanturk A, Yildirmak T, Arica D, Aydin D, Demirel N, Yokus O. Bloodstream infections in patients with hematological malignancies: which is more fatal - cancer or resistant pathogens? Ther Clin Risk Manag. 2014 Sep 17;10:743-52. doi: 10.2147/TCRM.S68450. eCollection 2014.
- Background: PubMed 14523785Yadegarynia D, Tarrand J, Raad I, Rolston K. Current spectrum of bacterial infections in patients with cancer. Clin Infect Dis. 2003 Oct 15;37(8):1144-5. doi: 10.1086/378305. No abstract available.
- Background: PubMed 23253612Brown GD, Denning DW, Gow NA, Levitz SM, Netea MG, White TC. Hidden killers: human fungal infections. Sci Transl Med. 2012 Dec 19;4(165):165rv13. doi: 10.1126/scitranslmed.3004404.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed Z Abo krisha, professor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bloodstream Infection, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 16 May 2023. 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 Egypt. 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.
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?
identify pathogens in positive blood culture in hematological malignancies patients (time frame: 1 year). The study lists 4 primary outcomes in all. 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 NCT03896880, which also lists 4 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 16 May 2023.