Acute Bacterial InfectionsAntibody 300NCT01646411
300 Antibody Diagnostic Test Kit
An observational study of Acute Bacterial Infections and Acute Viral Infections, run by The Plasma Source at 1 site in United States.
Trial summary
For the development of a Point of Care IVD test kit for acute phase disease detection against a variety of bacterial and viral infections. Phase one includes 100 clinical diagnosed positive and 200 clinically "normal" serum and whole blood matched specimens for specificity and sensitivity determination for each… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Bacterial Infections, Acute Viral Infections
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jul 2013
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with acute infection between the age of 18 and 70. Sex and race are random.
Who may be able to join
- current acute infection
- age 18-70
- male or female
- any race
- currently active symptoms
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study for Positive IgM Antibody Detection in New Diagnostic Test Kit for for Acute Phase Infection
For the development of a Point of Care IVD test kit for acute phase disease detection against a variety of bacterial and viral infections. Phase one includes 100 clinical diagnosed positive and 200 clinically "normal" serum and whole blood matched specimens for specificity and sensitivity determination for each marker. The positive samples must be IgM positive using any FDA cleared ELISA test kit. The negatives samples must be negative for IgM.
- Conditions
- Acute Bacterial Infections, Acute Viral Infections
- Keywords
- cytomegalovirus (CMV) IgM &IgG, Lyme, Toxoplasma, Rubella, Rubeola IgM, Rocky mountain Spotted Fever IgM, Ebv IgM, Herpes, Babesia, Measles, Tetanus, Mumps, Mycoplasma, Legionella, Giardia, Syphilis, Bordetella Pertussis, H Pylori, Antibody Titre, Elevated IgG
- Medical subject headings
- Hyper-IgM Immunodeficiency Syndrome, Type 1, Rubella, Herpes Simplex, Measles, Tetanus, Mumps, Mycoplasma Infections, Giardiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| assorted acute infection | 300 patients diagnosed with assorted acute infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgM greater than 1xcut off value
Elisa System positive results are greater than 1 times the cutoff. Negative less than 1x cutoff.
Prevalence of IGM in general mid-atlantic population is less than 10% of study population.
Measured: Antibody value measured within seven days of specimen collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2012 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Plasma Source
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Plasma Services Group
- Responsible party
- Sponsor
- Investigators
- Jeffery Flieshman, M.S immunology, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646411
- Sponsor's protocol ID
- 300831
- Acronym
- Antibody 300
- Status last verified
- Jul 2012
- First submitted
- 12 Jul 2012
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study for Positive IgM Antibody Detection in New Diagnostic Test Kit for for Acute Phase Infection
- ClinicalTrials.gov ID
- NCT01646411
- Acronym / sponsor ID
- Antibody 300 / 300831
- Conditions
- Acute Bacterial Infections, Acute Viral Infections
- Keywords
- cytomegalovirus (CMV) IgM &IgG, Lyme, Toxoplasma, Rubella, Rubeola IgM, Rocky mountain Spotted Fever IgM, Ebv IgM, Herpes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Plasma SourceIndustry (pharma, biotech, devices)
- Collaborators
- Plasma Services Group
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 20 Jul 2012 (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.
For the development of a Point of Care IVD test kit for acute phase disease detection against a variety of bacterial and viral infections. Phase one includes 100 clinical diagnosed positive and 200 clinically "normal" serum and whole blood matched specimens for specificity and sensitivity determination for each marker. The positive samples must be IgM positive using any FDA cleared ELISA test kit. The negatives samples must be negative for IgM.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| assorted acute infection | – | –300 patients diagnosed with assorted acute infection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute infection between the age of 18 and 70. Sex and race are random.
Key inclusion criteria (5 listed)
- current acute infection
- age 18-70
- male or female
- any race
- currently active symptoms
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IgM greater than 1xcut off value
Time frame: Antibody value measured within seven days of specimen collection.
Elisa System positive results are greater than 1 times the cutoff. Negative less than 1x cutoff. Prevalence of IGM in general mid-atlantic population is less than 10% of study population.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2012.
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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.
Jeffery Flieshman, M.S immunology study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Bacterial Infections and Acute Viral Infections, run by The Plasma Source at 1 site 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 5 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 20 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
IgM greater than 1xcut off value (time frame: Antibody value measured within seven days of specimen collection.). 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 20 Jul 2012.