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Randomized Controlled Trial
. 2019 Jun;78(6):454-460.
doi: 10.1016/j.jinf.2019.03.010. Epub 2019 Mar 23.

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

Behzad Nadjm  1 , Vu Quoc Dat  2 , James I Campbell  3 , Vu Tien Viet Dung  4 , Alessandro Torre  4 , Nguyen Thi Cam Tu  4 , Ninh Thi Thanh Van  4 , Dao Tuyet Trinh  5 , Nguyen Phu Huong Lan  6 , Nguyen Vu Trung  5 , Nguyen Thi Thuy Hang  5 , Le Thi Hoi  5 , Stephen Baker  3 , Marcel Wolbers  4 , Nguyen Van Vinh Chau  6 , Nguyen Van Kinh  5 , Guy E Thwaites  3 , H Rogier van Doorn  3 , Heiman F L Wertheim  7
Affiliations
Randomized Controlled Trial

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

Behzad Nadjm et al. J Infect. 2019 Jun.

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.

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Figures

Fig. 1
Fig. 1
Trial flow. a2 patients randomised to MALDITOF had identification by routine methods. They were analysed as per their randomisation arm (i.e. included in MALDITOF group).
Fig. 2
Fig. 2
Time from growth to optimal antimicrobial therapy (OAT).
See this image and copyright information in PMC

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