MALDITOF Versus Routine Clinical Microbiology for Identifying Pathogens; a Randomized Diagnostic Trial

NCT02306330 | Completed

• 1 other identifier: 09HN
• Study Type: interventional
• Target: 802
• Locations: 1 country
• Sites: 2

Brief Summary

MALDI-TOF MS is capable of directly identifying bacteria and fungi in positive blood cultures, which may be beneficial to patient management. Therefore, MALDI-TOF MS is an important new technology that is becoming routine in developed countries. It is currently unknown whether MALDITOF MS improves diagnostics, costs and patient outcomes in developing countries. This study will assess the clinical impact of a MALDITOF MS system (Maldi Biotyper, Bruker, Germany) in the resource constrained setting of Vietnam and at what cost.

Conditions

Bacterial Infections; Fungal Infections

Keywords

Malditof; Malditof MS; matrix-assisted laser desorption ionization-time; identifying pathogens; randomized diagnostic trial

Outcome Measures

Primary Outcomes (1)

• Proportion of patients on optimal antibiotic treatment

  Optimal antibiotic treatment is defined as an antibiotic treatment for at least 48 hours since positive culture, targeted to the identified pathogen and later found to cover the organisms antimicrobial resistance profile, while avoiding unnecessary broad spectrum antibiotics (e.g. avoid carbapenems or multiple agents where other agents or single agents would provide sufficient coverage). This study aims to determine The proportion of patients on optimal antibiotic treatment within 24 hours of positive culture (first growth of an eligible specimen).

  Within 24 hours of positive culture (first growth of an eligible specimen).

Secondary Outcomes (7)

• The total duration of antibiotic treatment

  During treatment course, estimated to be 7-10 days.

• The total number of antibiotic switches

  During treatment course, estimated to be 7-10 days.

• Length of ICU stay

  During ICU admission, estimated to be 7 days

• Length of hospital stay

  During hospital admission, estimated to be 12 days

• Patient outcome: death, palliative discharge, survived with sequelae, recovered

  On or before discharge, estimated to be at 12 days

Other Outcomes (6)

• Time from first growth of an eligible specimen to optimal antibiotic treatment.

  During hospital admission, estimated to be 0-48 hours

• Time from specimen collection of positive eligible specimen to optimal antibiotic treatment

  During hospital admission, estimated to be 0-48 hours

• The time from first recognition of isolate growth to issue of pathogen identification report

  Estimated 0-12 hours

Study Arms (2)

Malditof

EXPERIMENTAL

Specimens of patients (diagnostic aspirates from normally sterile sites: cerebrospinal fluid (CSF), deep abscesses, joint fluid, peritoneal fluid, and pleural fluid, deep tissue biopsies) in Malditof arm will be performed by Malditof instrument to identify the pathogens. It takes 20 minutes for Malditof to identify the pathogens. Then patients will be treated based on these results.

Device: Malditof

Routine clinical microbiology

ACTIVE COMPARATOR

Specimens of patients (diagnostic aspirates from normally sterile sites: cerebrospinal fluid (CSF), deep abscesses, joint fluid, peritoneal fluid, and pleural fluid, deep tissue biopsies) in routine clinical microbiology arm will be conducted by the routine clinical microbiologies and followed the treatment process of the hospital.

Other: Routine clinical microbiology

Interventions

Malditof DEVICE

Malditof MS system is applied for Malditof group for identifying pathogens. It takes 20 minutes to give the results.

Malditof

Routine clinical microbiology OTHER

Pathogens will be identified by the routine clinical microbiology of the hospital.

Routine clinical microbiology

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Specimens negative for all pathogens

Sponsors & Collaborators

• Oxford University Clinical Research Unit, Vietnam: lead
• National Hospital for Tropical Diseases, Hanoi, Vietnam: collaborator
• Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam: collaborator

Study Sites (2)

National Hospital for Tropical Diseases

Hà Nội, Vietnam

Location

Hospital for Tropical Diseases

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

• Nadjm B, Dat VQ, Campbell JI, Dung VTV, Torre A, Tu NTC, Van NTT, Trinh DT, Lan NPH, Trung NV, Hang NTT, Hoi LT, Baker S, Wolbers M, Chau NVV, Van Kinh N, Thwaites GE, van Doorn HR, Wertheim HFL. A randomised controlled trial of matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDITOF-MS) versus conventional microbiological methods for identifying pathogens: Impact on optimal antimicrobial therapy of invasive bacterial and fungal infections in Vietnam. J Infect. 2019 Jun;78(6):454-460. doi: 10.1016/j.jinf.2019.03.010. Epub 2019 Mar 23.

  PMID: 30914268 DERIVED

Related Links

• Oxford University Clinical Research Unit Viet Nam

MeSH Terms

Conditions

Bacterial Infections; Mycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Heiman Wertheim, MD, PhD

  Oxford University of Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 3, 2014
• Study Start: December 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2014-12

Locations

VN (2)