Drug HypersensitivityCephALLNCT04421638
Cephalosporin Hypersensitivity
An observational study of Drug Hypersensitivity, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Background : Although the hypersensitivity reactions to cephalosporins have been recently a more focused subject, studies on the cephalosporin as an allergen are significantly less frequent that those regarding penicillins. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Drug Hypersensitivity
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2020to 1 Jun 2020
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient consulting in our allergy unit for a suspicion of DHR to cephalosporins and who underwent a drug allergy work-up.
Who may be able to join
- Patients with one or more ST and DPT tests to cephalosporins
Who cannot join
- Patients refusing to take part in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Hypersensitivity Reactions To Cephalosporins
Background :
Although the hypersensitivity reactions to cephalosporins have been recently a more focused subject, studies on the cephalosporin as an allergen are significantly less frequent that those regarding penicillins. Most of the available data regards cephalosporin sensitization in patients previously allergic to penicillin. Like penicillins, cephalosporins represent one of the most prescribed classes of antibiotics. The diagnosis of cephalosporin hypersensitivity is based mainly on clinical history, skin tests (ST) and drug provocation tests (DPT). This succession of tests, performed in specialized services, allows to eliminate responsibility for the drug in many cases (80-85%). The drug allergy work-up also allows to identify profiles of allergy to cephalosporins, with different patterns of cross-reactivity.
Read more
Objective: To analyse the characteristics of patients studied in our Unit for suspicion of cephalosporin hypersensitivity.
Methods: This retrospective study will comprise all the patients who attended the allergy service of the UH of Montpellier from 1997 till 2018 with a clinical history evocative of cephalosporin drug hypersensitivity reaction (DHR), who underwent a drug allergy work up and who gave their consent to be included in the study . The Patients are selected from the Drug Allergy \& Hypersensitivity Database (DAHD).
- Conditions
- Drug Hypersensitivity
- Keywords
- Drug Hypersensitivity Reaction, Drug Provocation Test, Cephalosporins, Betalactams, Risk Factor
- Medical subject headings
- Drug Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify clinical variables associated with allergy to cephalosporins
Identify clinical variables associated with allergy to cephalosporins
Measured: 1 day
Secondary outcomes (2)
Determine the risk variables associated with allergy to cephalosporins
Determine the risk variables associated with allergy to cephalosporins
Measured: 1 day
To calculate the negative predictive value of cephalosporin DTP
In the subgroup of patients for whom we have data on readministration of a negatively tested cephalosporin following drug allergy work-up, we will calculate the negative predictive value of cephalosporin DPT.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start30 Jan 2020
- Primary completion1 May 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug HypersensitivityStudies 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
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anca Chiriac, MD,PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421638
- Sponsor's protocol ID
- RECHMPL20_0021
- Acronym
- CephALL
- Status last verified
- Apr 2020
- First submitted
- 8 Jan 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Hypersensitivity Reactions To Cephalosporins
- ClinicalTrials.gov ID
- NCT04421638
- Acronym / sponsor ID
- CephALL / RECHMPL20_0021
- Conditions
- Drug Hypersensitivity
- Keywords
- Drug Hypersensitivity Reaction, Drug Provocation Test, Cephalosporins, Betalactams, Risk Factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 9 Jun 2020 (actual)
- 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.
Background :
Although the hypersensitivity reactions to cephalosporins have been recently a more focused subject, studies on the cephalosporin as an allergen are significantly less frequent that those regarding penicillins. Most of the available data regards cephalosporin sensitization in patients previously allergic to penicillin. Like penicillins, cephalosporins represent one of the most prescribed classes of antibiotics. The diagnosis of cephalosporin hypersensitivity is based mainly on clinical history, skin tests (ST) and drug provocation tests (DPT). This succession of tests, performed in specialized services, allows to eliminate responsibility for the drug in many cases (80-85%). The drug allergy work-up also allows to identify profiles of allergy to cephalosporins, with different patterns of cross-reactivity.
Objective: To analyse the characteristics of patients studied in our Unit for suspicion of cephalosporin hypersensitivity.
Methods: This retrospective study will comprise all the patients who attended the allergy service of the UH of Montpellier from 1997 till 2018 with a clinical history evocative of cephalosporin drug hypersensitivity reaction (DHR), who underwent a drug allergy work up and who gave their consent to be included in the study . The Patients are selected from the Drug Allergy \& Hypersensitivity Database (DAHD).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient consulting in our allergy unit for a suspicion of DHR to cephalosporins and who underwent a drug allergy work-up.
Key inclusion criteria (1 listed)
- Patients with one or more ST and DPT tests to cephalosporins
Key exclusion criteria (1 listed)
- Patients refusing to take part in the study
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
Identify clinical variables associated with allergy to cephalosporins
Time frame: 1 day
Identify clinical variables associated with allergy to cephalosporins
2 secondary outcomes
Determine the risk variables associated with allergy to cephalosporins
Time frame: 1 day
To calculate the negative predictive value of cephalosporin DTP
Time frame: 1 years
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 9 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
Anca Chiriac, MD,PhD principal investigator
University Hospital, Montpellier
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 Drug Hypersensitivity, run by University Hospital, Montpellier at 1 site in France.
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 1 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 9 Jun 2020. 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 France. 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?
Identify clinical variables associated with allergy to cephalosporins (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2020.