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CompletedNCT01667055Updated Oct 29, 2019

The Diagnosis of Beta-lactam Hypersensitivity in Thailand

An observational study in Penicillin Allergy, Aminopenicillin Allergy and Beta Lactam Adverse Reaction, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2019-10-29.

Sponsored by Chulalongkorn University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
500
Ages
7 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Penicillin Allergy
  • Aminopenicillin Allergy
  • Beta Lactam Adverse Reaction

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Keywords

  • drug allergy
  • drug hypersensitivity
  • beta-lactam allergy
  • penicillin allergy
  • adverse drug reaction
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In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 500 is above the median of 115 across 479 observational studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
7 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with a history of beta-lactam hypersensitivity

Inclusion criteria

  • Patients with a history of beta-lactam hypersensitivity

Exclusion criteria

Exclusion Criteria:

  • Being pregnant
  • Having serious medical illnesses
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
500 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patients with suspected drug allergy

    Patients with a history of hypersensitivity reaction to beta-lactam antibiotics

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 1 year

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Study locations

1 site
  • Chulalongkorn University
    Bangkok, 10330, Thailand
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01667055
Lead sponsor
Chulalongkorn University
Responsible party
Assoc. Prof. Jettanong Klaewsongkram, MD. (Associate Professor, Chulalongkorn University) — Principal investigator
First posted
Aug 17, 2012
Start date
Jun 2012
Primary completion
Dec 2018
Completion
Dec 2018
Last update
Oct 29, 2019

Study contacts

Jettanong Klaewsongkram, MD
principal investigator · Chulalongkorn University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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