Cephalosporin AllergyNCT01248377
Skin Testing and ELISPOT Assay in Patients With a History of Non-Immediate Reactions to Cephalosporins
An observational study of Cephalosporin Allergy and Non-immediate Drug Reactions, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study aims to compare the results of skin testing and ELISPOT assay in patients with a history of non-immediate reactions to cephalosporins Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cephalosporin Allergy, Non-immediate Drug Reactions
- What is being tested?
- Skin tests and ELISPOT assay
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2010to May 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with a history of non-immediate hypersensitivity reactions to cephalosporins
Who may be able to join
- Patients with a history of non-immediate hypersensitivity reactions to cephalosporins
- At least 18 years of age
Who cannot join
- Suffering from severe systemic disease/ in bad health
- Being pregnant
- Patients with a history of immediate reactions to cephalosporin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Results of Skin Testing and The Detection of Cytokine Secretion From Drug Specific Peripheral Blood Mononuclear Cells Using ELISPOT Assay in the Diagnosis of Nonimmediate Reactions to Cephalosporins
This study aims to compare the results of skin testing and ELISPOT assay in patients with a history of non-immediate reactions to cephalosporins
Read the detailed description
Patients with a history of non-immediate reactions to cephalosporins will be tested by patch test and/or intradermal test. Peripheral blood mononuclear cells will be collected to analyzed cytokine secretions by ELISPOT assay
- Being tested
- Skin tests and ELISPOT assay
- Keywords
- Cephalosporins, Drug hypersensitivity
- Medical subject headings
- Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin tests and ELISPOT assayProcedure or surgery
Also called Patch test, Intradermal test, ELISPOT
Patch test and/or intradermal test will be performed in patients as well as cytokine secretions from PBMCs will be analyzed by ELISPOT assay
| Study group | Role | What they receive |
|---|---|---|
| Cephalosporins allergic patients | Not described Receives: Procedure: Skin tests and ELISPOT assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
The skin testing results of Cephalosporin skin test compared to ELISPOT assay
Measured: 1 year
Secondary outcomes (1)
The result of cross reactivity between Cephalosporins and other Betalactams determined by skin testing and ELISPOT assay
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 posted25 Nov 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2011
- Study completionMay 2011
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 Cephalosporin 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jettanong Klaewsongkram, Chulalongkorn University
- Investigators
- Jettanong Klaewsongkram, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248377
- Sponsor's protocol ID
- Chula-ARC 002/10
- Status last verified
- Oct 2011
- First submitted
- 24 Nov 2010
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tanvarasethee B, Buranapraditkun S, Klaewsongkram J. The potential of using enzyme-linked immunospot to diagnose cephalosporin-induced maculopapular exanthems. Acta Derm Venereol. 2013 Jan;93(1):66-9. doi: 10.2340/00015555-1386.
PubMed 22722755
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Results of Skin Testing and The Detection of Cytokine Secretion From Drug Specific Peripheral Blood Mononuclear Cells Using ELISPOT Assay in the Diagnosis of Nonimmediate Reactions to Cephalosporins
- ClinicalTrials.gov ID
- NCT01248377
- Acronym / sponsor ID
- Chula-ARC 002/10
- Keywords
- Cephalosporins, Drug hypersensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 25 Nov 2010 (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 results of skin testing and ELISPOT assay in patients with a history of non-immediate reactions to cephalosporins
Detailed description
Patients with a history of non-immediate reactions to cephalosporins will be tested by patch test and/or intradermal test. Peripheral blood mononuclear cells will be collected to analyzed cytokine secretions by ELISPOT assay
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cephalosporins allergic patients | – | Procedure: Skin tests and ELISPOT assay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a history of non-immediate hypersensitivity reactions to cephalosporins
Key inclusion criteria (2 listed)
- Patients with a history of non-immediate hypersensitivity reactions to cephalosporins
- At least 18 years of age
Key exclusion criteria (3 listed)
- Suffering from severe systemic disease/ in bad health
- Being pregnant
- Patients with a history of immediate reactions to cephalosporin
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 |
|---|---|---|
| Skin tests and ELISPOT assayAlso: Patch test, Intradermal test, ELISPOTPatch test and/or intradermal test will be performed in patients as well as cytokine secretions from PBMCs will be analyzed by ELISPOT assay | Procedure or surgery | Cephalosporins allergic patients |
Primary outcome
The skin testing results of Cephalosporin skin test compared to ELISPOT assay
Time frame: 1 year
1 secondary outcome
The result of cross reactivity between Cephalosporins and other Betalactams determined by skin testing and ELISPOT assay
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 12 Oct 2011.
- Derived from this study: PubMed 22722755Tanvarasethee B, Buranapraditkun S, Klaewsongkram J. The potential of using enzyme-linked immunospot to diagnose cephalosporin-induced maculopapular exanthems. Acta Derm Venereol. 2013 Jan;93(1):66-9. doi: 10.2340/00015555-1386.
Related trials for Cephalosporin Allergy
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Urinary Tract Infections, Antiobiotic Stewardship
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 Cephalosporin Allergy and Non-immediate Drug Reactions, 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 3 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 12 Oct 2011. 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 Cephalosporin skin test compared to ELISPOT assay (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 NCT01248377, 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 12 Oct 2011.