Blood Stream InfectionNCT05016752
Application of Nanopore Sequencing in Newly Diagnosed Acute Myeloid Leukemia Patients With Bloodstream Infection
An observational study of Blood Stream Infection and Gut Microbiota, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Acute myeloid leukemia (AML) patients are prone to blood stream infection (BSI) due to bone marrow suppression, oral and gastrointestinal mucositis, endovascular tubes, and the application of a large number of broad-spectrum antibiotics. The associated mortality rate is as high as 7.1 %-42%. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blood Stream Infection, Gut Microbiota, Acute Myeloid Leukemia
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2021to 30 Sep 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Newly diagnosed acute myeloid leukemia patients with neutropenia and bloodstream infection
Who may be able to join
- Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.
- No history of previous chemotherapy or target therapy.
- Neutrophil deficiency (ANC<0.5x10^9/L) with the first time fever(Oral temperature >=38.3 degree C or axillary temperature >=38.0 degree C) accompanied by chills or hemodynamic instability(BP <=90/60mmHg）
- Ability to comprehend the investigational nature of the study and provide informed consent.
Who cannot join
- Patients have a history of chemotherapy or target therapy.
- Patients with other commodities that the investigators considered not suitable for the enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
xiaowen tang, Ph.D, (0086)51267781856, xwtang1020@163.com
About this study
Official title: Application of Nanopore Sequencing in Newly Diagnosed Acute Myeloid Leukemia Patients With Neutropenia and Bloodstream Infection: a Prospective Multicenter Observational Clinical Study
Acute myeloid leukemia (AML) patients are prone to blood stream infection (BSI) due to bone marrow suppression, oral and gastrointestinal mucositis, endovascular tubes, and the application of a large number of broad-spectrum antibiotics. The associated mortality rate is as high as 7.1 %-42%. The use of antibiotics within one hour after the first observation of hypotensive symptoms can guarantee a 79.9% survival rate. For every hour of delay, the patient's survival rate will drop by 7.6%. At present, the blood culture test cycle is long and the positive rate is low. Other infection-related indicators (PCT, CRP) or next-generation sequencing are not highly specific and easy to be misdiagnosed. X-ray, CT and other examinations only have a certain auxiliary value for the infected site. We need new diagnostic tools to accurately identify pathogens. Nano-seq is a next-generation sequencing technology for single-molecule, real-time sequencing and analysis. With ultra-long sequencing read length, it can quickly and accurately identify BSI pathogens types, and give appropriate drug sensitivity results based on drug resistance genes to meet the needs of 99.9% pathogen screening. At the same time, we hope to conduct a prospective evaluation to target high-risk groups of AML prone to BSI in the early stage. The intestine is the body's largest immune organ and the largest reservoir of microbial pathogens. The expansion of certain gut microbiota usually precedes BSI. If there is a correlation between the gut microbiota and MDR-BSI, the colonization and changes of the intestinal flora can be used to predict the risk of BSI in patients during treatment, and preventive measures such as early decolonization or biological intervention will reduce the risk of infection in the future. Combined with Nano-seq and various existing clinical pathogen detection technologies to reduce the occurrence and progress of clinical BSI.
Read the detailed description
For AML patients with bloodstream infections, we analyzed and compared the sensitivity, specificity, and consistency of Nano-seq and traditional blood culture tests, and evaluated the advantages of Nano-seq for clinical diagnosis and treatment guidance of newly-treated AML bloodstream infections. At the same time, the homology analysis of gut microbiota and bloodstream infection strains was carried out to explore the correlation between gut microbiota and bloodstream infection in newly treated AML patients.
- Keywords
- Nanopore sequencing, Blood culture
- Medical subject headings
- Leukemia, Myeloid, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Nano-seq group compared to blood culture group
Proportion of samples where Nano-seq detects a pathogenic micro-organism that has been identified by blood culture diagnostic pathway.
Measured: Within 2 week of sampling.
Specificity of Nano-seq group compared to blood culture group
Proportion of samples where Nano-seq does not detect a micro-organism where blood culture diagnostic pathway has also not detected a micro-organism.
Measured: Within 2 week of sampling.
Level of agreement between Nano-seq group and blood culture group
Proportion of samples where the two methods produce the same result.
Measured: Within 2 week of sampling.
Secondary outcomes (3)
To compare the detection time, the intensity, duration and cost of antibiotics,length and cost of hospitalization between the Nano-seq group and blood culture group
To assess the difference between Nano-seq group and blood culture group in terms of timeliness and hospitalization costs
Measured: 3 months
Analyze the homology of the gut microbiota of patients with bloodstream infections and the detected strains
To assess the source of bloodstream infection and record the clinical high-risk factors and treatment outcomes
Measured: 3 months
Intestinal flora OTU clustering, genus abundance, Alpha diversity, Beta diversity, differences between LEfse groups, baseline value and subsequent changes in the prediction of the metabolic function of the gut microbiota
To assess the correlation between colonization and changes of gut microbiota and bloodstream infections
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start5 Aug 2021
- Primary completion31 Jul 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Stream InfectionStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haiping Dai, Ph.D, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016752
- Sponsor's protocol ID
- 2021174
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Nanopore Sequencing in Newly Diagnosed Acute Myeloid Leukemia Patients With Neutropenia and Bloodstream Infection: a Prospective Multicenter Observational Clinical Study
- ClinicalTrials.gov ID
- NCT05016752
- Acronym / sponsor ID
- 2021174
- Keywords
- Nanopore sequencing, Blood culture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 23 Aug 2021 (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.
Acute myeloid leukemia (AML) patients are prone to blood stream infection (BSI) due to bone marrow suppression, oral and gastrointestinal mucositis, endovascular tubes, and the application of a large number of broad-spectrum antibiotics. The associated mortality rate is as high as 7.1 %-42%. The use of antibiotics within one hour after the first observation of hypotensive symptoms can guarantee a 79.9% survival rate. For every hour of delay, the patient's survival rate will drop by 7.6%. At present, the blood culture test cycle is long and the positive rate is low. Other infection-related indicators (PCT, CRP) or next-generation sequencing are not highly specific and easy to be misdiagnosed. X-ray, CT and other examinations only have a certain auxiliary value for the infected site. We need new diagnostic tools to accurately identify pathogens. Nano-seq is a next-generation sequencing technology for single-molecule, real-time sequencing and analysis. With ultra-long sequencing read length, it can quickly and accurately identify BSI pathogens types, and give appropriate drug sensitivity results based on drug resistance genes to meet the needs of 99.9% pathogen screening. At the same time, we hope to conduct a prospective evaluation to target high-risk groups of AML prone to BSI in the early stage. The intestine is the body's largest immune organ and the largest reservoir of microbial pathogens. The expansion of certain gut microbiota usually precedes BSI. If there is a correlation between the gut microbiota and MDR-BSI, the colonization and changes of the intestinal flora can be used to predict the risk of BSI in patients during treatment, and preventive measures such as early decolonization or biological intervention will reduce the risk of infection in the future. Combined with Nano-seq and various existing clinical pathogen detection technologies to reduce the occurrence and progress of clinical BSI.
Detailed description
For AML patients with bloodstream infections, we analyzed and compared the sensitivity, specificity, and consistency of Nano-seq and traditional blood culture tests, and evaluated the advantages of Nano-seq for clinical diagnosis and treatment guidance of newly-treated AML bloodstream infections. At the same time, the homology analysis of gut microbiota and bloodstream infection strains was carried out to explore the correlation between gut microbiota and bloodstream infection in newly treated AML patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Newly diagnosed acute myeloid leukemia patients with neutropenia and bloodstream infection
Key inclusion criteria (4 listed)
- Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.
- No history of previous chemotherapy or target therapy.
- Neutrophil deficiency (ANC<0.5x10^9/L) with the first time fever(Oral temperature >=38.3 degree C or axillary temperature >=38.0 degree C) accompanied by chills or hemodynamic instability(BP <=90/60mmHg）
- Ability to comprehend the investigational nature of the study and provide informed consent.
Key exclusion criteria (2 listed)
- Patients have a history of chemotherapy or target therapy.
- Patients with other commodities that the investigators considered not suitable for the enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of Nano-seq group compared to blood culture group
Time frame: Within 2 week of sampling.
Proportion of samples where Nano-seq detects a pathogenic micro-organism that has been identified by blood culture diagnostic pathway.
Specificity of Nano-seq group compared to blood culture group
Time frame: Within 2 week of sampling.
Proportion of samples where Nano-seq does not detect a micro-organism where blood culture diagnostic pathway has also not detected a micro-organism.
Level of agreement between Nano-seq group and blood culture group
Time frame: Within 2 week of sampling.
Proportion of samples where the two methods produce the same result.
3 secondary outcomes
To compare the detection time, the intensity, duration and cost of antibiotics,length and cost of hospitalization between the Nano-seq group and blood culture group
Time frame: 3 months
Analyze the homology of the gut microbiota of patients with bloodstream infections and the detected strains
Time frame: 3 months
Intestinal flora OTU clustering, genus abundance, Alpha diversity, Beta diversity, differences between LEfse groups, baseline value and subsequent changes in the prediction of the metabolic function of the gut microbiota
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
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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.
Haiping Dai, Ph.D principal investigator
The First Affiliated Hospital of Soochow 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 Blood Stream Infection and Gut Microbiota, run by The First Affiliated Hospital of Soochow University at 1 site in China.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Aug 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaowen Tang, Ph.D ((0086)51267781856, xwtang1020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Nano-seq group compared to blood culture group (time frame: Within 2 week of sampling.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2021.