Negative Challenge to AmoxicillinREINADNCT04922034
Outcome of Patients After a Negative Oral Challenge to Amoxicillin
An observational study of Negative Challenge to Amoxicillin, run by University Hospital, Angers at 1 site in France.
Trial summary
This study aims to evaluate the outcome of patients who had a negative oral challenge to Amoxicillin Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Negative Challenge to Amoxicillin
- What is being tested?
- Amoxicillin
- Type of treatment
- Pill or oral medicine
- How many people
- 190 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2022to 18 Jul 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective, single-center, non-interventionnel study of patients with a negative oral challenge to Amoxicillin at Angers University Hospital between 2017 and 2019. An information letter indicating the purpose of the study is sent to eligible patients. If they do not object, patients are contacted by telephone one month after the information letter is sent, to answer the questionnaire. This questionnaire, filled in during the telephone interview, concerns the resumption or not of penicillins since the reintroduction test. This study concerns all patients, agreeing to participate in this study, who had a negative challenge test to Amoxicillin at the CHU of Angers from 2017 to 2019. The potential inclusion is approximately 200 individuals.
Who may be able to join
- Patients whith a negative challenge to Amoxicillin in the Allergology Department of the CHU of Angers between 2017 and 2019.
- Major patients.
Who cannot join
- Poor comprehension of the French language or cognitive disorders affecting the reliability of the questionnaire
- Person objecting to participate in this research and to the processing of their medical data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Patient's Outcomes After a Negative Reintroduction Test for Amoxicillin
This study aims to evaluate the outcome of patients who had a negative oral challenge to Amoxicillin
Read the detailed description
This is a prospective, single-center, non-interventional study of patients with negative Amoxicillin oral challenge performed at Angers University Hospital between 2017 and 2019.
An information letter indicating the purpose of the study is sent to eligible patients. If they do not object, patients are contacted by telephone to answer the questionnaire. This questionnaire concerns the reintroduction of penicillins at home after the challenge.
- Conditions
- Negative Challenge to Amoxicillin
- Being tested
- Amoxicillin
- Keywords
- penicillins, reintroduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Outcome of patients with negative oral challenge to amoxicillin
What is being measured
The primary outcome is the main question the study is designed to answer.
Resumption of Amoxicillin after a negative oral challenge to Amoxicillin
The main objective is to know if patients who had a negative test for reintroduction of Amoxicillin, have resumed this molecule afterwards.
Measured: Oral challenge test oxxuring between 2017 and 2019, and follow-up until the day of the call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start13 Jan 2022
- Primary completion18 Jul 2022
- Study completion18 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Negative Challenge to AmoxicillinStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922034
- Sponsor's protocol ID
- 49RC21_0178
- Acronym
- REINAD
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Patient's Outcomes After a Negative Reintroduction Test for Amoxicillin
- ClinicalTrials.gov ID
- NCT04922034
- Acronym / sponsor ID
- REINAD / 49RC21_0178
- Conditions
- Negative Challenge to Amoxicillin
- Keywords
- penicillins, reintroduction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 10 Jun 2021 (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.
This study aims to evaluate the outcome of patients who had a negative oral challenge to Amoxicillin
Detailed description
This is a prospective, single-center, non-interventional study of patients with negative Amoxicillin oral challenge performed at Angers University Hospital between 2017 and 2019.
An information letter indicating the purpose of the study is sent to eligible patients. If they do not object, patients are contacted by telephone to answer the questionnaire. This questionnaire concerns the reintroduction of penicillins at home after the challenge.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective, single-center, non-interventionnel study of patients with a negative oral challenge to Amoxicillin at Angers University Hospital between 2017 and 2019. An information letter indicating the purpose of the study is sent to eligible patients. If they do not object, patients are contacted by telephone one month after the information letter is sent, to answer the questionnaire. This questionnaire, filled in during the telephone interview, concerns the resumption or not of penicillins since the reintroduction test. This study concerns all patients, agreeing to participate in this study, who had a negative challenge test to Amoxicillin at the CHU of Angers from 2017 to 2019. The potential inclusion is approximately 200 individuals.
Key inclusion criteria (2 listed)
- Patients whith a negative challenge to Amoxicillin in the Allergology Department of the CHU of Angers between 2017 and 2019.
- Major patients.
Key exclusion criteria (2 listed)
- Poor comprehension of the French language or cognitive disorders affecting the reliability of the questionnaire
- Person objecting to participate in this research and to the processing of their medical data
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 |
|---|---|---|
| AmoxicillinOutcome of patients with negative oral challenge to amoxicillin | Drug | – |
Primary outcome
Resumption of Amoxicillin after a negative oral challenge to Amoxicillin
Time frame: Oral challenge test oxxuring between 2017 and 2019, and follow-up until the day of the call
The main objective is to know if patients who had a negative test for reintroduction of Amoxicillin, have resumed this molecule afterwards.
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 22 Sep 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Negative Challenge to Amoxicillin, run by University Hospital, Angers 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 2 inclusion and 2 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 22 Sep 2023. 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?
Resumption of Amoxicillin after a negative oral challenge to Amoxicillin (time frame: Oral challenge test oxxuring between 2017 and 2019, and follow-up until the day of the call). 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 22 Sep 2023.