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

Oxford University Clinical Research Unit, Vietnam

Status: Completed

Conditions: Fungal Infections; Bacterial Infections

Treatments: Other: Routine clinical microbiology; Device: Malditof

Study type: Interventional

Funder types: Other

Identifiers

NCT02306330

09HN

Details and patient eligibility

About

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.

Full 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).

Enrollment: 802 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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802 participants in 2 patient groups

Malditof

Experimental group

Description:

Specimens of patients (diagnostic aspirates from normally sterile sites: cerebrospinal fluid (CSF), deep abscesses, joint fluid, peritoneal fluid, and pleural fluid, deep tissue biopsies) in Malditof arm will be performed by Malditof instrument to identify the pathogens. It takes 20 minutes for Malditof to identify the pathogens. Then patients will be treated based on these results.

Treatment:

Device: Malditof

Routine clinical microbiology

Active Comparator group

Description:

Specimens of patients (diagnostic aspirates from normally sterile sites: cerebrospinal fluid (CSF), deep abscesses, joint fluid, peritoneal fluid, and pleural fluid, deep tissue biopsies) in routine clinical microbiology arm will be conducted by the routine clinical microbiologies and followed the treatment process of the hospital.

Treatment:

Other: Routine clinical microbiology