Clinical trial NCT03896880: Detection of Bloodstream Pathogens in Hematological Malignancies
Official title: Detection of Bloodstream Pathogens in Hematological Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bloodstream Infection
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hematological malignancy patients with fever

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

Eligibility criteria: Inclusion Criteria:

* hematological malignancy patients on chemotherapy associated with fever

Exclusion Criteria:

* Age below 18 years old

Primary outcomes:
measure: identify pathogens in positive blood culture in hematological malignancies patients
timeFrame: 1 year
measure: Antimicrobial susceptibility testing and drug resistance
timeFrame: 1 year
measure: prevalence of bloodstream infection in hematological malignancy patients
timeFrame: 1 year
measure: Time from blood collection to pathogen identification
timeFrame: 1 year
Secondary outcomes:
measure: In-hospital mortality.
timeFrame: 1 year
measure: Rapid diagnosis of bloodstream infections
timeFrame: 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
affiliation: Assiut University
name: Mohamed Z Abo krisha, professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Gedik 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.
citation: Yadegarynia 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.
citation: Brown 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.