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

Bacterial Infections Clinical Trial

Official 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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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). ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02306330
Study type	Interventional
Source	Oxford University Clinical Research Unit, Vietnam
Contact
Status	Completed
Phase	N/A
Start date	December 2014
Completion date	January 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.