Infections

All Conditions

Neoplasms

Blood and Lymph Conditions

Symptoms and General Pathology

Hematologic Neoplasms

Communicable Diseases

Sepsis

Toxemia

Hematologic Diseases

Syndrome

Systemic Inflammatory Response Syndrome

Inflammation

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

Anti-Infective Agents, Local

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Hormones

Hormone Antagonists

Cytochrome P-450 CYP3A Inhibitors

hematological malignancy patients with positive 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:

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

blood culture

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

Anti fungal susceptibility testing or antibiotic susceptibility testing

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.

phenotypic identification methods of the isolated organism by Vitek2 (BioMerieux,France)

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).

Identification of the isolated organism by multiplex PCR

Mohamed Z Abo krisha, professor

* 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 )

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

Detection of Bloodstream Pathogens in Hematological Malignancies

Examine blood culture to diagnose different species of pathogens including bacteria and fungi responsible for bloodstream infection in hematological malignancies patients.

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 both bacteremia and fungemia in hematological malignancies using blood culture

The hypothesis is that faster identification will lead to faster action.

Faster treatment is associated with reduced mortality

Compare different methods for rapid identification of blood culture positive results including Vitek2 (BioMerieux,France) and multiplex PCR

Assiut University

Principle investigator

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neutropenia

Disease Attributes

Neoplasms by Histologic Type

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Granulocytopenia

Acute Graft Versus Host Disease

Xiaowen Tang, Ph.D

xiaowen tang, Ph.D

Haiping Dai, Ph.D

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.

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.

Application of Nanopore Sequencing in Newly Diagnosed Acute Myeloid Leukemia Patients With Bloodstream Infection

Application of Nanopore Sequencing in Newly Diagnosed Acute Myeloid Leukemia Patients With Neutropenia and Bloodstream Infection: a Prospective Multicenter Observational Clinical Study

Proportion of samples where Nano-seq detects a pathogenic micro-organism that has been identified by blood culture diagnostic pathway.

Proportion of samples where Nano-seq does not detect a micro-organism where blood culture diagnostic pathway has also not detected a micro-organism.

Proportion of samples where the two methods produce the same result.

To assess the difference between Nano-seq group and blood culture group in terms of timeliness and hospitalization costs

To assess the source of bloodstream infection and record the clinical high-risk factors and treatment outcomes

To assess the correlation between colonization and changes of gut microbiota and bloodstream infections

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Detection of Bloodstream Pathogens in Hematological Malignancies	NCT03896880	Bloodstream Inf...	blood culture Anti fungal sus... phenotypic iden... Identification ...	18 Years -	Assiut University
Application of Nanopore Sequencing in Newly Diagnosed Acute Myeloid Leukemia Patients With Bloodstream Infection	NCT05016752	Blood Stream In... Gut Microbiota Acute Myeloid L...		-	The First Affiliated Hospital of Soochow University
Detection of Bloodstream Pathogens in Hematological Malignancies	NCT03896880	Bloodstream Inf...	blood culture Anti fungal sus... phenotypic iden... Identification ...	18 Years -	Assiut University

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