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.

Abstract

Objectives: We assessed the impact of MALDITOF-MS on the timeliness of optimal antimicrobial therapy through a parallel-arm randomised controlled trial in two hospitals in Vietnam.

Methods: We recruited patients with a pathogen (bacterial or fungal) cultured from a normally sterile sample. Samples were randomly assigned (1:1) to identification by MALDITOF-MS or conventional diagnostics. The primary outcome was the proportion on optimal antimicrobial therapy within 24 h of positive culture, determined by a blinded independent review committee. Trial registered at ClinicalTrials.gov (NCT02306330).

Results: Among 1005 randomised patients, pathogens were isolated from 628 (326 intervention, 302 control), with 377 excluded as likely contaminants or discharged/died before positive culture. Most isolates were cultured from blood (421/628, 67.0%). The proportion receiving optimal antimicrobial therapy within 24 h (the primary outcome) or 48 h of growth was not significantly different between MALDITOF-MS and control arms (135/326, 41.4% vs 120/302, 39.7%; Adjusted Odds ration (AOR) 1.17, p = 0.40 and 151/326, 46.3% vs 141/302, 46.7%; AOR 1.05 p = 0.79, respectively).

Conclusions: MALDITOF-MS, in the absence of an antimicrobial stewardship programme, did not improve the proportion on optimal antimicrobial therapy at 24 or 48 h after first growth in a lower-middle income setting with high rates of antibiotic resistance.

Keywords: Antibacterial agents; Bacteraemia; Matrix-assisted laser desorption-ionization mass spectrometry; Microbiological techniques; Vietnam.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Bacterial Agents / therapeutic use
  • Antifungal Agents / therapeutic use
  • Bacteremia / diagnosis
  • Bacteremia / drug therapy*
  • Bacteremia / microbiology
  • Bacteria / drug effects
  • Bacteria / isolation & purification*
  • Female
  • Fungi / drug effects
  • Fungi / isolation & purification*
  • Humans
  • Male
  • Microbiological Techniques*
  • Middle Aged
  • Mycoses / diagnosis
  • Mycoses / drug therapy*
  • Mycoses / microbiology
  • Prospective Studies
  • Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization*
  • Time Factors
  • Treatment Outcome
  • Vietnam

Substances

  • Anti-Bacterial Agents
  • Antifungal Agents

Associated data

  • ClinicalTrials.gov/NCT02306330