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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 November 2016
• Main ID: NCT02306330
• Date of registration: 01/12/2014
• Prospective Registration: Yes
• Primary sponsor: Oxford University Clinical Research Unit, Vietnam
• Public title: MALDITOF Versus Routine Clinical Microbiology for Identifying Pathogens; a Randomized Diagnostic Trial MALDITOF
• Scientific 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
• Date of first enrolment: December 2014
• Target sample size: 802
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02306330
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
• Phase: N/A

Countries of recruitment

Vietnam

Contacts

• Name: Heiman Wertheim, MD, PhD
• Affiliation: Oxford University of Clinical Research

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Bacterial Infections

Fungal Infections

Intervention(s)

Other: Routine clinical microbiology

Device: Malditof

Primary Outcome(s)

Proportion of patients on optimal antibiotic treatment [Time Frame: Within 24 hours of positive culture (first growth of an eligible specimen).]

Secondary Outcome(s)

The total number of antibiotic switches [Time Frame: During treatment course, estimated to be 7-10 days.]

Costs of microbiological testing [Time Frame: On or before discharge, estimated to be at 12 days]

Length of hospital stay [Time Frame: During hospital admission, estimated to be 12 days]

Patient outcome: death, palliative discharge, survived with sequelae, recovered [Time Frame: On or before discharge, estimated to be at 12 days]

Treatment and hospital costs [Time Frame: On or before discharge, estimated to be at 12 days]

The total duration of antibiotic treatment [Time Frame: During treatment course, estimated to be 7-10 days.]

Length of ICU stay [Time Frame: During ICU admission, estimated to be 7 days]

Secondary ID(s)

09HN

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

National Hospital for Tropical Diseases, Hanoi, Vietnam