NCT01667055

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

6.5 years

First QC Date

August 15, 2012

Last Update Submit

October 27, 2019

Conditions

Penicillin AllergyAminopenicillin AllergyBeta Lactam Adverse Reaction

Keywords

drug allergydrug hypersensitivitybeta-lactam allergypenicillin allergyadverse drug reaction

Outcome Measures

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

    1 year

Secondary Outcomes (1)

  • Clinical values of various diagnostic modalities in patients with a history of beta-lactam hypersensitivity

    1 year

Study Arms (1)

Patients with suspected drug allergy

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

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a history of beta-lactam hypersensitivity

You may qualify if:

  • Patients with a history of beta-lactam hypersensitivity

You may not qualify if:

  • Being pregnant
  • Having serious medical illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 36122888DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood mononuclear cells in patients with a history of non-immediate reaction

MeSH Terms

Conditions

Drug HypersensitivityDrug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Jettanong Klaewsongkram, MD

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 15, 2012

First Posted

August 17, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 29, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)