Transfusion Transmitted BabesiosisPhase 3NCT01528449
Babesia Testing in Blood Donors
A Phase 3 study testing B.microti diagnostic blood tests in people with Transfusion Transmitted Babesiosis, run by Imugen at 1 site in United States.
Trial summary
Both prospective and retrospective (look back) study of blood donors for laboratory evidence of babesia microti infection. Two laboratory methodologies will be utilized: 1. - PCR, to look for the presence of B.microti in whole blood 2. - IFA, to look for significant titers of B.microti antibody Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transfusion Transmitted Babesiosis
- What is being tested?
- B.microti diagnostic blood tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90,116 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Sep 2014
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- same as for donating blood
Who cannot join
- donor refusual to sign informed consent for this investigational babesia testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Donation Screening for Babesia Microti by Real-time Polymerase Chain Reaction (PCR) and by Indirect Flourescent Antibody (IFA) Assays
Both prospective and retrospective (look back) study of blood donors for laboratory evidence of babesia microti infection.
Two laboratory methodologies will be utilized:
- - PCR, to look for the presence of B.microti in whole blood
- - IFA, to look for significant titers of B.microti antibody
Read the detailed description
Retrospective study will involve archived specimens from blood donors whose units have already been released and transfused into recipients.
Prospective study will be real time and units testing positive by either PCR or IFA will be not released and will be disgarded, and the donors advised and deferred from further blood donation
- Conditions
- Transfusion Transmitted Babesiosis
- Being tested
- B.microti diagnostic blood tests
- Keywords
- babesia, blood donation, transfusion transmitted babesiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B.microti diagnostic blood testsBiological
Also called proprietary in-house developed PCR and IFA Babesia doagnostic tests
the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
B.microti diagnostic blood testsBiological
the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
| Study group | Role | What they receive |
|---|---|---|
| retrospective | Experimental | archived specimens from blood donors whose units have already been released and transfused into recipients will be tested. Attempts will be made to contact and obtain follow up specimens from both the donor and recipient of units initially testing positive for B.microti. the interventions are investigational diagnostic tests for B.microti (PCR and IFA). Receives: Biological: B.microti diagnostic blood tests |
| prospective, real time | Experimental | specimens from current blood donors will be tested and those testing positive for B.microti will not be released and the units will be disgarded, and the donors notified and deferred from future blood donation. the interventions are investigational diagnostic tests for B.microti (PCR and IFA). Receives: Biological: B.microti diagnostic blood tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of blood donors testing positive for evidence of Babesia infection
Measured: goal is up to one year (all specimens by end 2012)
Secondary outcomes (1)
the number of cases of transfusion transmitted babesia infection identified
Measured: goal is up to one year (all specimens by end 2012)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionSep 2014
- Study completionSep 2014
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 Transfusion Transmitted BabesiosisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90,116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imugen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American National Red Cross, Memorial Blood Centers, Minnesota, Rhode Island Blood Center
- Responsible party
- Sponsor
- Investigators
- Philip J Molloy, MD, Principal investigator, Imugen Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528449
- Sponsor's protocol ID
- BNATIFA-10
- Status last verified
- Sep 2017
- First submitted
- 31 Jan 2012
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Moritz ED, Winton CS, Tonnetti L, Townsend RL, Berardi VP, Hewins ME, Weeks KE, Dodd RY, Stramer SL. Screening for Babesia microti in the U.S. Blood Supply. N Engl J Med. 2016 Dec 8;375(23):2236-2245. doi: 10.1056/NEJMoa1600897.
PubMed 27959685
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Donation Screening for Babesia Microti by Real-time Polymerase Chain Reaction (PCR) and by Indirect Flourescent Antibody (IFA) Assays
- ClinicalTrials.gov ID
- NCT01528449
- Acronym / sponsor ID
- BNATIFA-10
- Conditions
- Transfusion Transmitted Babesiosis
- Keywords
- babesia, blood donation, transfusion transmitted babesiosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90,116 participants (actual)
- Lead sponsor
- ImugenIndustry (pharma, biotech, devices)
- Collaborators
- American National Red Cross, Memorial Blood Centers, Minnesota, Rhode Island Blood Center
- Study start
- Dec 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 8 Feb 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.
Both prospective and retrospective (look back) study of blood donors for laboratory evidence of babesia microti infection.
Two laboratory methodologies will be utilized:
- - PCR, to look for the presence of B.microti in whole blood
- - IFA, to look for significant titers of B.microti antibody
Detailed description
Retrospective study will involve archived specimens from blood donors whose units have already been released and transfused into recipients.
Prospective study will be real time and units testing positive by either PCR or IFA will be not released and will be disgarded, and the donors advised and deferred from further blood donation
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retrospective | Experimental | Biological: B.microti diagnostic blood testsarchived specimens from blood donors whose units have already been released and transfused into recipients will be tested. Attempts will be made to contact and obtain follow up specimens from both the donor and recipient of units initially testing positive for B.microti. the interventions are investigational diagnostic tests for B.microti (PCR and IFA). |
| prospective, real time | Experimental | Biological: B.microti diagnostic blood testsspecimens from current blood donors will be tested and those testing positive for B.microti will not be released and the units will be disgarded, and the donors notified and deferred from future blood donation. the interventions are investigational diagnostic tests for B.microti (PCR and IFA). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- same as for donating blood
Key exclusion criteria (1 listed)
- donor refusual to sign informed consent for this investigational babesia testing
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 |
|---|---|---|
| B.microti diagnostic blood testsAlso: proprietary in-house developed PCR and IFA Babesia doagnostic teststhe interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA). | Biological | retrospective |
| B.microti diagnostic blood teststhe interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA). | Biological | prospective, real time |
Primary outcome
number of blood donors testing positive for evidence of Babesia infection
Time frame: goal is up to one year (all specimens by end 2012)
1 secondary outcome
the number of cases of transfusion transmitted babesia infection identified
Time frame: goal is up to one year (all specimens by end 2012)
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 12 Sep 2017.
- Derived from this study: PubMed 27959685Moritz ED, Winton CS, Tonnetti L, Townsend RL, Berardi VP, Hewins ME, Weeks KE, Dodd RY, Stramer SL. Screening for Babesia microti in the U.S. Blood Supply. N Engl J Med. 2016 Dec 8;375(23):2236-2245. doi: 10.1056/NEJMoa1600897.
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.
Philip J Molloy, MD principal investigator
Imugen Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing B.microti diagnostic blood tests in people with Transfusion Transmitted Babesiosis, run by Imugen 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 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 12 Sep 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
number of blood donors testing positive for evidence of Babesia infection (time frame: goal is up to one year (all specimens by end 2012)). 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 NCT01528449, 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 12 Sep 2017.