Penicillin AllergyNCT01667055
The Diagnosis of Beta-lactam Hypersensitivity in Thailand
An observational study of Penicillin Allergy and Aminopenicillin Allergy, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity will be determined by using commercially available standard skin test reagents and the diagnostic agents available in Thailand. We hypothesize that only minority of patients with such a history are truly allergic. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Penicillin Allergy, Aminopenicillin Allergy, Beta Lactam Adverse Reaction
- How many people
- 500 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2012to Dec 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a history of beta-lactam hypersensitivity
Who may be able to join
- Patients with a history of beta-lactam hypersensitivity
Who cannot join
- Being pregnant
- Having serious medical illnesses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Optimized Diagnostic Methods for the Confirmation of Beta-lactam Hypersensitivity in Thailand
The true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity will be determined by using commercially available standard skin test reagents and the diagnostic agents available in Thailand. We hypothesize that only minority of patients with such a history are truly allergic.
Read the detailed description
Patients with a history of beta-lactam hypersensitivity will be evaluated by the standard skin test reagents (major and minor determinants of penicillin, amoxicillin, and clavulanic if applicable), and intravenous forms of beta-lactam antibiotics .
Diagnostic values of the measurement of specific Immunoglobulin E to penicillin/aminopenicillin and skin test reagents currently available in Thailand will be comparatively analyzed with the standard skin test reagents.
The measurement of drug-induced interferon-gamma releasing cells will be measured in patients with a history of non-immediate reaction.
- Keywords
- drug allergy, drug hypersensitivity, beta-lactam allergy, penicillin allergy, adverse drug reaction
- Medical subject headings
- Drug Hypersensitivity, Drug-Related Side Effects and Adverse Reactions
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 |
|---|---|---|
| Patients with suspected drug allergy | Patients with a history of hypersensitivity reaction to beta-lactam antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
The true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity
The skin test positive rate in patients with a history of beta-lactam hypersensitivity
Measured: 1 year
Secondary outcomes (1)
Clinical values of various diagnostic modalities in patients with a history of beta-lactam hypersensitivity
The diagnostic values of skin testing, drug-specific Immunoglobulin E measurement, and interferon-gamma ELISpot assay for the diagnosis of beta-lactam hypersensitivity
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 posted17 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2018
- Study completionDec 2018
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. Prof. Jettanong Klaewsongkram, MD., Chulalongkorn University
- Investigators
- Jettanong Klaewsongkram, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667055
- Sponsor's protocol ID
- Chula-ARC 002/12
- Status last verified
- Oct 2019
- First submitted
- 15 Aug 2012
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chongpison Y, Palapinyo S, Mongkolpathumrat P, Buranapraditkun S, Thantiworasit P, Klaewsongkram J. Beta-lactam hypersensitivity diagnosis in ambulatory and hospitalized settings require different approaches. Ann Allergy Asthma Immunol. 2023 Jan;130(1):84-92.e1. doi: 10.1016/j.anai.2022.09.011. Epub 2022 Sep 16.
PubMed 36122888
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimized Diagnostic Methods for the Confirmation of Beta-lactam Hypersensitivity in Thailand
- ClinicalTrials.gov ID
- NCT01667055
- Acronym / sponsor ID
- Chula-ARC 002/12
- Keywords
- drug allergy, drug hypersensitivity, beta-lactam allergy, penicillin allergy, adverse drug reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 17 Aug 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.
The true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity will be determined by using commercially available standard skin test reagents and the diagnostic agents available in Thailand. We hypothesize that only minority of patients with such a history are truly allergic.
Detailed description
Patients with a history of beta-lactam hypersensitivity will be evaluated by the standard skin test reagents (major and minor determinants of penicillin, amoxicillin, and clavulanic if applicable), and intravenous forms of beta-lactam antibiotics .
Diagnostic values of the measurement of specific Immunoglobulin E to penicillin/aminopenicillin and skin test reagents currently available in Thailand will be comparatively analyzed with the standard skin test reagents.
The measurement of drug-induced interferon-gamma releasing cells will be measured in patients with a history of non-immediate reaction.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected drug allergy | – | –Patients with a history of hypersensitivity reaction to beta-lactam antibiotics |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a history of beta-lactam hypersensitivity
Key inclusion criteria (1 listed)
- Patients with a history of beta-lactam hypersensitivity
Key exclusion criteria (2 listed)
- Being pregnant
- Having serious medical illnesses
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
The true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity
Time frame: 1 year
The skin test positive rate in patients with a history of beta-lactam hypersensitivity
1 secondary outcome
Clinical values of various diagnostic modalities in patients with a history of beta-lactam hypersensitivity
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 Oct 2019.
- Derived from this study: PubMed 36122888Chongpison Y, Palapinyo S, Mongkolpathumrat P, Buranapraditkun S, Thantiworasit P, Klaewsongkram J. Beta-lactam hypersensitivity diagnosis in ambulatory and hospitalized settings require different approaches. Ann Allergy Asthma Immunol. 2023 Jan;130(1):84-92.e1. doi: 10.1016/j.anai.2022.09.011. Epub 2022 Sep 16.
- Individual participant dataSharing planned: No
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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?
An observational study of Penicillin Allergy and Aminopenicillin 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 1 inclusion and 2 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 Oct 2019. 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 true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity (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 NCT01667055, 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 Oct 2019.