Penicillin AllergyNCT00789217
Penicillin Skin Testing in Patients With History of Allergic Reactions to Betalactams
A study testing Immediate skin test in people with Penicillin Allergy, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study aims to compare the readings of skin testing results in patients with suspected penicillin allergy between in-house penicillin test preparation and commercial available penicillin testing kit. Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Penicillin Allergy
- What is being tested?
- Immediate skin test
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2008to Aug 2010
- 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 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with history of hypersensitivity reactions to betalactams; penicillin, aminopenicillins, and cephalosporins
- 15-65 years of age
Who cannot join
- On antihistamine/ cannot discontinue antihistamine before the test
- Having asthma exacerbation
- Being pregnant
- Suffering from severe systemic disease/ in bad health
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparative Results of Penicillin Testing in Patients With History of Allergic Reactions to Betalactams Between Using In-house Penicillin Test Preparation and Commercial Available Penicillin Testing Kit
This study aims to compare the readings of skin testing results in patients with suspected penicillin allergy between in-house penicillin test preparation and commercial available penicillin testing kit.
Read the detailed description
The results of skin test with immediate reading will be compared between alkali-treated penicillin G and DAP reagents from Diater
- Conditions
- Penicillin Allergy
- Being tested
- Immediate skin test
- Keywords
- Penicillin, Beta-Lactams, Allergy, Hypersensitivity
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate skin testProcedure or surgery
Also called Intradermal test with reading at 15 minutes after injection
Intradermal test with immediate reading
| Study group | Role | What they receive |
|---|---|---|
| In-house penicillin testing preparation | Active comparator | In-house penicillin testing prepared from alkali-treated penicillin G Receives: Procedure: Immediate skin test |
| Commercial penicillin test kit | Active comparator | Commercial penicillin test kit order from Diater company Receives: Procedure: Immediate skin test |
| Penicillin G Sodium | Active comparator | Penicillin G Sodium from routine clinical use Receives: Procedure: Immediate skin test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The skin testing results of in-house penicillin skin test and Penicillin G Sodium compared to commercial penicillin testing kit
Measured: 1 year
Secondary outcomes (2)
Clinical correlation and side effects
Measured: 1 year
Correlations between Penicillin skin test result with specific IgE and/or basophil activation test
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionMar 2010
- Study completionAug 2010
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 Penicillin AllergyStudies of the same condition, open and under way.
- More trials run by Chulalongkorn 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University
- Investigators
- Jettanong Klaewsongkram, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789217
- Sponsor's protocol ID
- Chula-ARC 001/08
- Status last verified
- Nov 2010
- First submitted
- 7 Nov 2008
- Last updated
- 29 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Wangrattanasopon P, Ruxrungtham K, Chantaphakul H, Buranapraditkun S, Klaewsongkram J. Alkali-treated penicillin G solution is a better option than penicillin G as an alternative source of minor determinants for penicillin skin test. Allergy Asthma Proc. 2012 Mar-Apr;33(2):152-9. doi: 10.2500/aap.2012.33.3496.
PubMed 22525392
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Results of Penicillin Testing in Patients With History of Allergic Reactions to Betalactams Between Using In-house Penicillin Test Preparation and Commercial Available Penicillin Testing Kit
- ClinicalTrials.gov ID
- NCT00789217
- Acronym / sponsor ID
- Chula-ARC 001/08
- Conditions
- Penicillin Allergy
- Keywords
- Penicillin, Beta-Lactams, Allergy, Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Mahidol University
- Study start
- Dec 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 11 Nov 2008 (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 study aims to compare the readings of skin testing results in patients with suspected penicillin allergy between in-house penicillin test preparation and commercial available penicillin testing kit.
Detailed description
The results of skin test with immediate reading will be compared between alkali-treated penicillin G and DAP reagents from Diater
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In-house penicillin testing preparation | Active comparator | Procedure: Immediate skin testIn-house penicillin testing prepared from alkali-treated penicillin G |
| Commercial penicillin test kit | Active comparator | Procedure: Immediate skin testCommercial penicillin test kit order from Diater company |
| Penicillin G Sodium | Active comparator | Procedure: Immediate skin testPenicillin G Sodium from routine clinical use |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with history of hypersensitivity reactions to betalactams; penicillin, aminopenicillins, and cephalosporins
- 15-65 years of age
Key exclusion criteria (4 listed)
- On antihistamine/ cannot discontinue antihistamine before the test
- Having asthma exacerbation
- Being pregnant
- Suffering from severe systemic disease/ in bad health
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 |
|---|---|---|
| Immediate skin testAlso: Intradermal test with reading at 15 minutes after injectionIntradermal test with immediate reading | Procedure or surgery | Commercial penicillin test kit, In-house penicillin testing preparation, Penicillin G Sodium |
Primary outcome
The skin testing results of in-house penicillin skin test and Penicillin G Sodium compared to commercial penicillin testing kit
Time frame: 1 year
2 secondary outcomes
Clinical correlation and side effects
Time frame: 1 year
Correlations between Penicillin skin test result with specific IgE and/or basophil activation test
Time frame: 1 year
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 29 Nov 2010.
- Derived from this study: PubMed 22525392Wangrattanasopon P, Ruxrungtham K, Chantaphakul H, Buranapraditkun S, Klaewsongkram J. Alkali-treated penicillin G solution is a better option than penicillin G as an alternative source of minor determinants for penicillin skin test. Allergy Asthma Proc. 2012 Mar-Apr;33(2):152-9. doi: 10.2500/aap.2012.33.3496.
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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.
Jettanong Klaewsongkram, MD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate skin test in people with Penicillin Allergy, run by Chulalongkorn University at 1 site in Thailand.
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 2 inclusion and 4 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 29 Nov 2010. 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 Thailand. 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?
The skin testing results of in-house penicillin skin test and Penicillin G Sodium compared to commercial penicillin testing kit (time frame: 1 year). 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 NCT00789217, 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 29 Nov 2010.