Febrile InfectionNCT03498027
Febrile Whole Blood Specimen Collection and Testing
An observational study of Febrile Infection and Anthrax, run by MRI Global at 3 sites in United States.
Trial summary
Whole blood samples will be collected from febrile patients presenting with fever of unknown origin and flu-like syndromes. Collection sites will consent patients and collect one (1) 4 mL whole blood sample from adults and either (1) 2 mL pediatric whole blood sample or 0.5 mL whole blood sample collected in a micro… Read more about this study
- Who is it for?
- Ages 2 to 89 years
- Conditions the study is for
- Febrile Infection, Anthrax
- What is being tested?
- TaqMan Bacillus anthracis Detection Kit
- Type of treatment
- Medical device
- How many people
- 97 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Jul 2018to 18 Oct 2018
- Phase
- Observational
- 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 2 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inclusion criteria to be documented on data form provided. * Fever of unknown origin * Flu like syndrome Age ranges of study participants is as follows: 2-15 Years of age 15-21 Years of age 22-40 Years of age >40 Years of age
Who may be able to join
- Fever
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New England Center for Clinical Research
Fall River, Massachusetts, 02720
Medical Research Network
Franklin, Massachusetts, 02038
Boca Biolistics
Tarpon Springs, Florida, 33319
About this study
Official title: Febrile Whole Blood Specimen Collection and Testing Protocol to Demonstrate Product Specificity for the Applied Biosystems™ Bacillus Anthracis Detection Kit
Whole blood samples will be collected from febrile patients presenting with fever of unknown origin and flu-like syndromes. Collection sites will consent patients and collect one (1) 4 mL whole blood sample from adults and either (1) 2 mL pediatric whole blood sample or 0.5 mL whole blood sample collected in a micro collection container from pediatric patients from each patient enrolled into the study. Study site will test whole blood samples received from collection sites daily using the Applied Biosystems™ Bacillus anthracis Detection Kit. Data generated will demonstrate product specificity when testing febrile whole blood samples.
Read the detailed description
Whole blood samples will be collected from febrile patients presenting with fever of unknown origin and flu-like syndromes. Collection sites will be advised of collection requirements specific to patient population with the goal of collecting samples form patient between the ages of 2-89 years of age. Samples collected will be de-identified and assigned a specific study number. Study numbers and labels will be provided to collection site by the study monitor. Samples must be shipped to MRIGlobal or designated study site on the day of collection.
Collection sites will consent patients and collect one (1) 4 mL whole blood sample from adults and either (1) 2 mL pediatric whole blood sample or 0.5 mL whole blood sample collected in a micro collection container from pediatric patients (anticoagulant: K2EDTA or defined alternative) from each patient enrolled into the study. Patients may not be enrolled in the study more than once. Patients considered for enrollment will be logged on an enrollment log. Log must be reviewed by the site prior to considering a patient for study enrollment to confirm enrollment status. Samples collected will be de-identified and assigned a specific study number. Study numbers and labels will be provided to collection site by the study monitor.
Study site will accept or reject samples based on shipping verification procedures and then process samples acceptable for testing within 24 hours of receipt. Sample testing must be performed in accordance with the Applied Biosystems™ Bacillus anthracis Detection Kit instructions for use.
At study start, study site will test whole blood samples received from collection sites daily (e.g. Tuesday, Wednesday, Thursday, and Friday) using the Applied Biosystems™ Bacillus anthracis Detection Kit. No reference testing will be required since the study is designed only to demonstrate product specificity. Samples are assumed to be negative for Bacillus anthracis. A minimum of 50, but likely 100 febrile whole blood samples will be tested at MRIGlobal.
Data generated will demonstrate product specificity when testing febrile whole blood samples.
- Conditions
- Febrile Infection, Anthrax
- Being tested
- TaqMan Bacillus anthracis Detection Kit
- Medical subject headings
- Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaqMan Bacillus anthracis Detection KitDevice
The TaqMan® Bacillus anthracis Detection Kit is composed of the Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software, secondary interpretative software, and lyophilized reagents for the detection of gene targets for B. anthracis. The test assay is a multiplexed assay targeting gene targets for B. anthracis, in addition to an internal positive control. Reagents are lyophilized as a fully formulated Mastermix and are stable at room temperature for up to two years. The kit is specifically designed for performing real-time PCR using the Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software , with nucleic acids extracted from clinical specimens using Qiagen's QIAamp® Blood Midi Kit manual extraction or Roche MagNAPure automated extraction methods.
| Study group | Role | What they receive |
|---|---|---|
| Data Collection | Not described Receives: Device: TaqMan Bacillus anthracis Detection Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Product Specificity
Data generated will demonstrate product specificity when testing whole blood samples.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start26 Jul 2018
- Primary completion18 Oct 2018
- Study completion18 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile InfectionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- MRI Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498027
- Sponsor's protocol ID
- MRI-2017-004/5
- Status last verified
- Dec 2018
- First submitted
- 6 Apr 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Febrile Whole Blood Specimen Collection and Testing Protocol to Demonstrate Product Specificity for the Applied Biosystems™ Bacillus Anthracis Detection Kit
- ClinicalTrials.gov ID
- NCT03498027
- Acronym / sponsor ID
- MRI-2017-004/5
- Conditions
- Febrile Infection, Anthrax
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- MRI GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 13 Apr 2018 (actual)
- 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.
Whole blood samples will be collected from febrile patients presenting with fever of unknown origin and flu-like syndromes. Collection sites will consent patients and collect one (1) 4 mL whole blood sample from adults and either (1) 2 mL pediatric whole blood sample or 0.5 mL whole blood sample collected in a micro collection container from pediatric patients from each patient enrolled into the study. Study site will test whole blood samples received from collection sites daily using the Applied Biosystems™ Bacillus anthracis Detection Kit. Data generated will demonstrate product specificity when testing febrile whole blood samples.
Detailed description
Whole blood samples will be collected from febrile patients presenting with fever of unknown origin and flu-like syndromes. Collection sites will be advised of collection requirements specific to patient population with the goal of collecting samples form patient between the ages of 2-89 years of age. Samples collected will be de-identified and assigned a specific study number. Study numbers and labels will be provided to collection site by the study monitor. Samples must be shipped to MRIGlobal or designated study site on the day of collection.
Collection sites will consent patients and collect one (1) 4 mL whole blood sample from adults and either (1) 2 mL pediatric whole blood sample or 0.5 mL whole blood sample collected in a micro collection container from pediatric patients (anticoagulant: K2EDTA or defined alternative) from each patient enrolled into the study. Patients may not be enrolled in the study more than once. Patients considered for enrollment will be logged on an enrollment log. Log must be reviewed by the site prior to considering a patient for study enrollment to confirm enrollment status. Samples collected will be de-identified and assigned a specific study number. Study numbers and labels will be provided to collection site by the study monitor.
Study site will accept or reject samples based on shipping verification procedures and then process samples acceptable for testing within 24 hours of receipt. Sample testing must be performed in accordance with the Applied Biosystems™ Bacillus anthracis Detection Kit instructions for use.
At study start, study site will test whole blood samples received from collection sites daily (e.g. Tuesday, Wednesday, Thursday, and Friday) using the Applied Biosystems™ Bacillus anthracis Detection Kit. No reference testing will be required since the study is designed only to demonstrate product specificity. Samples are assumed to be negative for Bacillus anthracis. A minimum of 50, but likely 100 febrile whole blood samples will be tested at MRIGlobal.
Data generated will demonstrate product specificity when testing febrile whole blood samples.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Data Collection | – | Device: TaqMan Bacillus anthracis Detection Kit |
Who may qualify
- Ages
- 2 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inclusion criteria to be documented on data form provided. * Fever of unknown origin * Flu like syndrome Age ranges of study participants is as follows: 2-15 Years of age 15-21 Years of age 22-40 Years of age >40 Years of age
Key inclusion criteria (1 listed)
- Fever
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| TaqMan Bacillus anthracis Detection KitThe TaqMan® Bacillus anthracis Detection Kit is composed of the Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software, secondary interpretative software, and lyophilized reagents for the detection of gene targets for B. anthracis. The test assay is a multiplexed assay targeting gene targets for B. anthracis, in addition to an internal positive control. Reagents are lyophilized as a fully formulated Mastermix and are stable at room temperature for up to two years. The kit is specifically designed for performing real-time PCR using the Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software , with nucleic acids extracted from clinical specimens using Qiagen's QIAamp® Blood Midi Kit manual extraction or Roche MagNAPure automated extraction methods. | Device | Data Collection |
Primary outcome
Product Specificity
Time frame: 1 day
Data generated will demonstrate product specificity when testing whole blood samples.
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 19 Dec 2018.
- Individual participant dataSharing planned: No
Related trials for Febrile Infection
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
Not yet recruitingPhase 1
A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of a Preventative Vaccine for Marburg Virus (mRNA-1519) in Healthy Adult Participants
Marburg Virus Disease (MVD)
Active, not recruitingPhase 3
A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population
Yellow Fever Immunization
RecruitingObservational study
Diagnosis and Management of Inflammatory and Infectious Diseases
Infection, Inflammation
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Infection and Anthrax, run by MRI Global at 3 sites in United States.
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 1 inclusion and 1 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 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Product Specificity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2018.