Detection of Bloodstream Pathogens in Hematological Malignancies

NCT03896880 | Completed DMC

• 1 other identifier: Cancer bloodstream infection
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

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 )

Conditions

Bloodstream Infection

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  1 year

• prevalence of bloodstream infection in hematological malignancy patients

  prevalence of both bacteremia and fungemia in hematological malignancies using blood culture

  1 year

• Time from blood collection to pathogen identification

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

  1 year

Secondary Outcomes (2)

• In-hospital mortality.

  1 year

• Rapid diagnosis of bloodstream infections

  1 year

Study Arms (1)

blood culture positive

hematological malignancy patients with positive blood culture

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

Interventions

blood culture DIAGNOSTIC_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: 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 positive

Anti fungal susceptibility testing or antibiotic susceptibility testing OTHER

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

Also known as: antimicrobial susceptibility testing

blood culture positive

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

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.

Also known as: Vitek2 (BioMerieux,France)

blood culture positive

Identification of the isolated organism by multiplex PCR OTHER

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).

Also known as: FilmArray blood culture identification (BCID), multiplex PCR

blood culture positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

hematological malignancy patients with fever

You may qualify if:

• hematological malignancy patients on chemotherapy associated with fever

You may not qualify if:

• Age below 18 years old

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, Egypt

Location

Related Publications (4)

• 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.

  PMID: 25299714 BACKGROUND

• 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.

  PMID: 25258539 BACKGROUND

• 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.

  PMID: 14523785 BACKGROUND

• 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.

  PMID: 23253612 BACKGROUND

MeSH Terms

Conditions

Sepsis

Interventions

Blood Culture; Multiplex Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques

Study Officials

• Mohamed Z Abo krisha, professor

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 1, 2019
• Study Start: January 1, 2020
• Primary Completion: February 28, 2022
• Study Completion: May 1, 2022
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

EG (1)