AnaphylaxisNCT00868842
Desensitization of Human Mast Cells: Mechanisms and Potential Utility for Preventing Anaphylaxis
An observational study of Anaphylaxis, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This is an open-label, single-center study of whether oral penicillin desensitization of healthy sensitive subjects results in allergen cross-desensitization of mast cells by skin testing and desensitization of peripheral blood basophils. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anaphylaxis
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2012
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Clinical and community recruitment
Who may be able to join
- Written informed consent obtained.
- Male, or non-pregnant female, 18-45 years of age who are in good health.
- Clinical history of a penicillin allergy consisting of an immediate hyper- sensitivity reaction such as anaphylaxis, urticaria/angioedema or broncho- spasm, and a positive skin prick test to penicillin G.
- Positive skin test to at least one aeroallergen to indicate sensitivity, but clinical disease (allergic rhinitis) is not necessary.
Who cannot join
- Dermatographism or severe dermatologic condition, such as advanced eczema or psoriasis, that will not allow an adequate uninvolved area for skin testing.
- Negative skin tests to penicillin G or to all aeroallergens test.
- Pregnancy.
- Antihistamine medications taken within one week of testing; systemic steroids, B-blockers or ACE -inhibitors taken over the previous month; omalizumab therapy at any time; those receiving or who have received immunotherapy; and those who have been desensitized to any drug within 6 months.
- Allergic reaction to a B-lactam antibiotic within 1 month.
- Current asthma; significant pulmonary, cardiovascular, renal, hepatobiliary or neurological diseases, or another disease process that the investigator feel would put the subject at risk of an adverse event.
- Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
- Inability or unwillingness of a participant to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Open-label, Single-center Study of Whether Oral Penicillin Desensitization of Healthy Sensitive Subjects Results in Allergen Cross-desensitization of Mast Cells by Skin Testing and Desensitization of Peripheral Blood Basophils.
This is an open-label, single-center study of whether oral penicillin desensitization of healthy sensitive subjects results in allergen cross-desensitization of mast cells by skin testing and desensitization of peripheral blood basophils. The primary endpoint(s) will be PC3 prick skin test values to penicillin, aeroallergen(s) and codeine. Secondary endpoints will be levels of Syk in purified basophils determined by flow cytometry (mean fluorescence intensity) and basophil degranulation (% tryptase release) to anti-FcåRI and to calcium ionophore.
- Conditions
- Anaphylaxis
- Keywords
- Penicillin, Allergy, Prevention, Anaphylaxis, Clinically proven history of penicillin allergy, preventing anaphylaxis
- Medical subject headings
- Anaphylaxis, Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased skin test sensitivity to Pre-pen (PC3 value)
Measured: June 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaphylaxisStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Lawrence B. Schwartz, M.D., Ph.D, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868842
- Sponsor's protocol ID
- HM10870
- Other IDs
- AADCRC-VCU-01
- Status last verified
- Apr 2014
- First submitted
- 23 Mar 2009
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single-center Study of Whether Oral Penicillin Desensitization of Healthy Sensitive Subjects Results in Allergen Cross-desensitization of Mast Cells by Skin Testing and Desensitization of Peripheral Blood Basophils.
- ClinicalTrials.gov ID
- NCT00868842
- Acronym / sponsor ID
- HM10870
- Conditions
- Anaphylaxis
- Keywords
- Penicillin, Allergy, Prevention, Anaphylaxis, Clinically proven history of penicillin allergy, preventing anaphylaxis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Mar 2009 (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.
This is an open-label, single-center study of whether oral penicillin desensitization of healthy sensitive subjects results in allergen cross-desensitization of mast cells by skin testing and desensitization of peripheral blood basophils. The primary endpoint(s) will be PC3 prick skin test values to penicillin, aeroallergen(s) and codeine. Secondary endpoints will be levels of Syk in purified basophils determined by flow cytometry (mean fluorescence intensity) and basophil degranulation (% tryptase release) to anti-FcåRI and to calcium ionophore.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Clinical and community recruitment
Key inclusion criteria (4 listed)
- Written informed consent obtained.
- Male, or non-pregnant female, 18-45 years of age who are in good health.
- Clinical history of a penicillin allergy consisting of an immediate hyper- sensitivity reaction such as anaphylaxis, urticaria/angioedema or broncho- spasm, and a positive skin prick test to penicillin G.
- Positive skin test to at least one aeroallergen to indicate sensitivity, but clinical disease (allergic rhinitis) is not necessary.
Key exclusion criteria (8 listed)
- Dermatographism or severe dermatologic condition, such as advanced eczema or psoriasis, that will not allow an adequate uninvolved area for skin testing.
- Negative skin tests to penicillin G or to all aeroallergens test.
- Pregnancy.
- Antihistamine medications taken within one week of testing; systemic steroids, B-blockers or ACE -inhibitors taken over the previous month; omalizumab therapy at any time; those receiving or who have received immunotherapy; and those who have been desensitized to any drug within 6 months.
- Allergic reaction to a B-lactam antibiotic within 1 month.
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
Decreased skin test sensitivity to Pre-pen (PC3 value)
Time frame: June 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 14 Apr 2014.
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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.
Lawrence B. Schwartz, M.D., Ph.D principal investigator
Virginia Commonwealth University
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 Anaphylaxis, run by Virginia Commonwealth University 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 4 inclusion and 8 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 14 Apr 2014. 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?
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?
Decreased skin test sensitivity to Pre-pen (PC3 value) (time frame: June 2012). 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 14 Apr 2014; AzTrials last refreshed its copy on 8 Nov 2026.