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NCT Number: NCT02306330

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

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.

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Fungal Infections Infections Mycoses

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Malditof

Device

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

Routine clinical microbiology

Other

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

Primary outcomes

  1. Proportion of patients on optimal antibiotic treatment

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

    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).

Secondary outcomes

  1. The total duration of antibiotic treatment

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

  2. The total number of antibiotic switches

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

  3. Length of ICU stay

    Time frame: During ICU admission, estimated to be 7 days

  4. Length of hospital stay

    Time frame: During hospital admission, estimated to be 12 days

  5. Patient outcome: death, palliative discharge, survived with sequelae, recovered

    Time frame: On or before discharge, estimated to be at 12 days

  6. Costs of microbiological testing

    Time frame: On or before discharge, estimated to be at 12 days

  7. Treatment and hospital costs

    Time frame: On or before discharge, estimated to be at 12 days

Other outcomes

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

    Time frame: During hospital admission, estimated to be 0-48 hours

  2. Time from specimen collection of positive eligible specimen to optimal antibiotic treatment

    Time frame: During hospital admission, estimated to be 0-48 hours

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

    Time frame: Estimated 0-12 hours

  4. The time from specimen collection to issue of pathogen identification report

    Time frame: Estimated 24-48 hours

  5. Time from first specimen collection to discharge

    Time frame: Estimated to be 12 days

  6. Time from first pathogen identification to discharge

    Time frame: Estimated to be 10 days

Sponsors and collaborators

Lead sponsor

Oxford University Clinical Research Unit, Vietnam

Other

Collaborators

  • Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
  • National Hospital for Tropical Diseases, Hanoi, Vietnam

Registry information

Official study 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

Acronym: MALDITOF

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 3, 2014
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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