Bacterial InfectionsMALDITOFNCT02306330
MALDITOF Versus Routine Clinical Microbiology for Identifying Pathogens; a Randomized Diagnostic Trial
A study testing Malditof and Routine clinical microbiology in people with Bacterial Infections and Fungal Infections, run by Oxford University Clinical Research Unit, Vietnam at 2 sites in Vietnam.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bacterial Infections, Fungal Infections
- What is being tested?
- Malditof and Routine clinical microbiology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 802 participants
- Where
- 2 sitesVietnam
- Study dates
- Dec 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Vietnam2 sites
National Hospital for Tropical Diseases
Hà Nội
Hospital for Tropical Diseases
Ho Chi Minh City
About this study
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
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.
Read the detailed 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).
- Conditions
- Bacterial Infections, Fungal Infections
- Being tested
- Malditof, Routine clinical microbiology
- Keywords
- Malditof, Malditof MS, matrix-assisted laser desorption ionization-time, identifying pathogens, randomized diagnostic trial
- Medical subject headings
- Bacterial Infections, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MalditofDevice
Malditof MS system is applied for Malditof group for identifying pathogens. It takes 20 minutes to give the results.
Routine clinical microbiologyOther
Pathogens will be identified by the routine clinical microbiology of the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Malditof | Experimental | 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. Receives: Device: Malditof |
| Routine clinical microbiology | Active comparator | 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. Receives: Other: Routine clinical microbiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients on optimal antibiotic treatment
Optimal antibiotic treatment is defined as an antibiotic treatment for at least 48 hours since positive culture, targeted to the identified pathogen and later found to cover the organisms antimicrobial resistance profile, while avoiding unnecessary broad spectrum antibiotics (e.g. avoid carbapenems or multiple agents where other agents or single agents would provide sufficient coverage). This study aims to determine The proportion of patients on optimal antibiotic treatment within 24 hours of positive culture (first growth of an eligible specimen).
Measured: Within 24 hours of positive culture (first growth of an eligible specimen).
Secondary outcomes (7)
The total duration of antibiotic treatment
Measured: During treatment course, estimated to be 7-10 days.
The total number of antibiotic switches
Measured: During treatment course, estimated to be 7-10 days.
Length of ICU stay
Measured: During ICU admission, estimated to be 7 days
Length of hospital stay
Measured: During hospital admission, estimated to be 12 days
Patient outcome: death, palliative discharge, survived with sequelae, recovered
Measured: On or before discharge, estimated to be at 12 days
Costs of microbiological testing
Measured: On or before discharge, estimated to be at 12 days
Treatment and hospital costs
Measured: On or before discharge, estimated to be at 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 802 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- National Hospital for Tropical Diseases, Hanoi, Vietnam, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
- Responsible party
- Sponsor
- Investigators
- Heiman Wertheim, MD, PhD, Principal investigator, Oxford University of Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306330
- Sponsor's protocol ID
- 09HN
- Acronym
- MALDITOF
- Status last verified
- Dec 2014
- First submitted
- 1 Dec 2014
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Nadjm B, Dat VQ, Campbell JI, Dung VTV, Torre A, Tu NTC, Van NTT, Trinh DT, Lan NPH, Trung NV, Hang NTT, Hoi LT, Baker S, Wolbers M, Chau NVV, Van Kinh N, Thwaites GE, van Doorn HR, Wertheim HFL. 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.
PubMed 30914268
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02306330
- Acronym / sponsor ID
- MALDITOF / 09HN
- Conditions
- Bacterial Infections, Fungal Infections
- Keywords
- Malditof, Malditof MS, matrix-assisted laser desorption ionization-time, identifying pathogens, randomized diagnostic trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- National Hospital for Tropical Diseases, Hanoi, Vietnam, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
- Study start
- Dec 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malditof | Experimental | Device: MalditofSpecimens 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. |
| Routine clinical microbiology | Active comparator | Other: Routine clinical microbiologySpecimens 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MalditofMalditof MS system is applied for Malditof group for identifying pathogens. It takes 20 minutes to give the results. | Device | Malditof |
| Routine clinical microbiologyPathogens will be identified by the routine clinical microbiology of the hospital. | Other | Routine clinical microbiology |
Primary outcome
Proportion of patients on optimal antibiotic treatment
Time frame: Within 24 hours of positive culture (first growth of an eligible specimen).
Optimal antibiotic treatment is defined as an antibiotic treatment for at least 48 hours since positive culture, targeted to the identified pathogen and later found to cover the organisms antimicrobial resistance profile, while avoiding unnecessary broad spectrum antibiotics (e.g. avoid carbapenems or multiple agents where other agents or single agents would provide sufficient coverage). This study aims to determine The proportion of patients on optimal antibiotic treatment within 24 hours of positive culture (first growth of an eligible specimen).
7 secondary outcomes
The total duration of antibiotic treatment
Time frame: During treatment course, estimated to be 7-10 days.
The total number of antibiotic switches
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
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
Costs of microbiological testing
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Derived from this study: PubMed 30914268Nadjm B, Dat VQ, Campbell JI, Dung VTV, Torre A, Tu NTC, Van NTT, Trinh DT, Lan NPH, Trung NV, Hang NTT, Hoi LT, Baker S, Wolbers M, Chau NVV, Van Kinh N, Thwaites GE, van Doorn HR, Wertheim HFL. 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.
- Oxford University Clinical Research Unit Viet NamLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heiman Wertheim, MD, PhD principal investigator
Oxford University of Clinical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Malditof and Routine clinical microbiology in people with Bacterial Infections and Fungal Infections, run by Oxford University Clinical Research Unit, Vietnam at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients on optimal antibiotic treatment (time frame: Within 24 hours of positive culture (first growth of an eligible specimen).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02306330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.