Clinical trial NCT02306330: MALDITOF Versus Routine Clinical Microbiology for Identifying Pathogens; a Randomized Diagnostic Trial
Official title: Assessing Time to Reporting and Clinical Management of Patients With Severe Bacterial and Fungal Infections Between Two Diagnostic Approaches: Matrix-assisted Laser Desorption Ionization-time of Flight Mass Spectrometry Versus Routine Clinical Microbiology for Identifying Pathogens; a Randomized Diagnostic Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Infections
Fungal Infections
Keywords: Malditof
Malditof MS
matrix-assisted laser desorption ionization-time
identifying pathogens
randomized diagnostic trial
Lead sponsor: Oxford University Clinical Research Unit, Vietnam
Sponsor class: OTHER
Collaborators: name: National Hospital for Tropical Diseases, Hanoi, Vietnam
name: Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
First posted: 2014-12-03
Enrollment: 802
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: When an eligible specimen from a patient shows pathogen growth, the pathogen identification will be randomized to either MaldiTof or routine diagnostics ('diagnostic pipelines'). Randomization to MaldiTof or routine diagnostics will be 1:1 with stratification by hospital and specimen type (blood vs. other). Isolates grown from all eligible specimens of the same patient will be assigned to the same diagnostic pipeline as the first randomized specimen of that patient.

Allocation to diagnostic arm will be assigned by a web based randomization program. When a pathogen is isolated from a positive eligible specimen, the laboratory technician will log onto the secure randomization program and enter the patient and specimen code. The random diagnostic pipeline allocation will then be generated, informed to the laboratory technician and logged in the study database. In the case of multiple specimens with pathogen growth for a single patient, the unique patient code will trigger the randomization program to generate the same diagnostic arm allocation as the previous sample(s).

Eligibility criteria: Inclusion Criteria: Pathogen isolates from the following specimens: blood or diagnostic aspirates from normally sterile sites (including cerebrospinal fluid (CSF), deep abscesses, joint fluid, peritoneal fluid, and pleural fluid, deep tissue biopsies).

Exclusion Criteria:

* Specimens negative for all pathogens
* Specimens from sputum, respiratory or non-surgical wound swabs, nails, mucosal or skin biopsies, urine, fluid from drains, skin swabs and any others not listed in the inclusion criteria.

Primary outcomes:
measure: Proportion of patients on optimal antibiotic treatment
timeFrame: Within 24 hours of positive culture (first growth of an eligible specimen).
Secondary outcomes:
measure: The total duration of antibiotic treatment
timeFrame: During treatment course, estimated to be 7-10 days.
measure: The total number of antibiotic switches
timeFrame: During treatment course, estimated to be 7-10 days.
measure: Length of ICU stay
timeFrame: During ICU admission, estimated to be 7 days
measure: Length of hospital stay
timeFrame: During hospital admission, estimated to be 12 days
measure: Patient outcome: death, palliative discharge, survived with sequelae, recovered
timeFrame: On or before discharge, estimated to be at 12 days
measure: Costs of microbiological testing
timeFrame: On or before discharge, estimated to be at 12 days
measure: Treatment and hospital costs
timeFrame: On or before discharge, estimated to be at 12 days
Other outcomes:
measure: Time from first growth of an eligible specimen to optimal antibiotic treatment.
timeFrame: During hospital admission, estimated to be 0-48 hours
measure: Time from specimen collection of positive eligible specimen to optimal antibiotic treatment
timeFrame: During hospital admission, estimated to be 0-48 hours
measure: The time from first recognition of isolate growth to issue of pathogen identification report
timeFrame: Estimated 0-12 hours
measure: The time from specimen collection to issue of pathogen identification report
timeFrame: Estimated 24-48 hours
measure: Time from first specimen collection to discharge
timeFrame: Estimated to be 12 days
measure: Time from first pathogen identification to discharge
timeFrame: Estimated to be 10 days
Locations:
city: Ha Noi
country: Vietnam
facility: National Hospital for Tropical Diseases
city: Ho CHi Minh City
country: Vietnam
facility: Hospital for Tropical Diseases
Study officials:
affiliation: Oxford University of Clinical Research
name: Heiman Wertheim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.