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
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.
- 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