Detection of Bloodstream Pathogens in Hematological Malignancies

Completed

• Conditions: Bloodstream Infection
• Interventions: 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

• Registration Number: NCT03896880
• Lead Sponsor: Assiut University

Brief 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 )

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 Timeline

• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-04-01
• Study Start: 2020-01-01
• Primary Completion: 2022-02-28
• Study Completion: 2022-05-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-14
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

• hematological malignancy patients on chemotherapy associated with fever

Exclusion Criteria

• Age below 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
blood culture positive	phenotypic identification methods of the isolated organism by Vitek2 (BioMerieux,France)	hematological malignancy patients with positive blood culture
blood culture positive	blood culture	hematological malignancy patients with positive blood culture
blood culture positive	Anti fungal susceptibility testing or antibiotic susceptibility testing	hematological malignancy patients with positive blood culture
blood culture positive	Identification of the isolated organism by multiplex PCR	hematological malignancy patients with positive blood culture

Primary Outcome Measures

Name	Time	Method
identify pathogens in positive blood culture in hematological malignancies patients	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	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	1 year	prevalence of both bacteremia and fungemia in hematological malignancies using blood culture
Time from blood collection to pathogen identification	1 year	The hypothesis is that faster identification will lead to faster action.

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality.	1 year	Faster treatment is associated with reduced mortality
Rapid diagnosis of bloodstream infections	1 year	Compare different methods for rapid identification of blood culture positive results including Vitek2 (BioMerieux,France) and multiplex PCR

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, Egypt