EndocarditisAmox-CloxaNCT05142891
Renal Tolerance of Amoxicillin and Cloxacillin Combination
An observational study of Endocarditis and Acute Kidney Injury, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
2015 European Society of Cardiology Guidelines have proposed the combination of Ampicillin and Cloxacillin for initial empirical treatment of infective endocarditis in acute severely ill patients (before pathogen identification). Yet this combination has never been studied in clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocarditis, Acute Kidney Injury
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2021to 30 Oct 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
- Adult, Older adult
Study population: Adult patient hospitalized at the Strasbourg University Hospital and treated concomitantly with Amoxicillin IV and Cloxacillin IV for ≥48 hours between January 1, 2016 and December 31, 2020.
Who may be able to join
- Adult patient (≥18 years old)
- Hospitalized at the Strasbourg University Hospital and treated concomitantly with Amoxicillin IV and Cloxacillin IV for ≥48 hours between January 1, 2016 and December 31, 2020.
- Patient not having expressed his opposition, after information, to the reuse of his data for scientific research purposes.
Who cannot join
- Subject having expressed opposition to participating in the study
- Subject under guardianship, curatorship or safeguard of justice
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Yvon RUCH, MD, 33 3 69 55 12 19, yvon.ruch@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Official title: Incidence of Actue Kidney Injury in Patients Treated With Amoxicillin and Cloxacillin Combination Therapy
2015 European Society of Cardiology Guidelines have proposed the combination of Ampicillin and Cloxacillin for initial empirical treatment of infective endocarditis in acute severely ill patients (before pathogen identification). Yet this combination has never been studied in clinical trials. High dose penicillin treatments are associated with a risk of nephrotoxicity.
The investigator's primary purpose is to describe patients treated with high dose Amoxicillin and Cloxacillin combination and to evaluate its renal tolerance.
- Conditions
- Endocarditis, Acute Kidney Injury
- Keywords
- Endocarditis, Acute kidney injury, Amoxicillin, Cloxacillin
- Medical subject headings
- Endocarditis, Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of patients treated with dual IV therapy combining cloxacillin and amoxicillin in high doses at Strasbourg University Hospital
Measured: Files analysed retrospectively from January 01, 2016 to December 31, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start15 Oct 2021
- Primary completionOct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndocarditisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yvon RUCH, MD, Principal investigator, Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142891
- Sponsor's protocol ID
- 8411
- Acronym
- Amox-Cloxa
- Status last verified
- Nov 2021
- First submitted
- 19 Nov 2021
- Last updated
- 3 Dec 2021
- 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 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Actue Kidney Injury in Patients Treated With Amoxicillin and Cloxacillin Combination Therapy
- ClinicalTrials.gov ID
- NCT05142891
- Acronym / sponsor ID
- Amox-Cloxa / 8411
- Conditions
- Endocarditis, Acute Kidney Injury
- Keywords
- Endocarditis, Acute kidney injury, Amoxicillin, Cloxacillin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 3 Dec 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.
2015 European Society of Cardiology Guidelines have proposed the combination of Ampicillin and Cloxacillin for initial empirical treatment of infective endocarditis in acute severely ill patients (before pathogen identification). Yet this combination has never been studied in clinical trials. High dose penicillin treatments are associated with a risk of nephrotoxicity.
The investigator's primary purpose is to describe patients treated with high dose Amoxicillin and Cloxacillin combination and to evaluate its renal tolerance.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient hospitalized at the Strasbourg University Hospital and treated concomitantly with Amoxicillin IV and Cloxacillin IV for ≥48 hours between January 1, 2016 and December 31, 2020.
Key inclusion criteria (3 listed)
- Adult patient (≥18 years old)
- Hospitalized at the Strasbourg University Hospital and treated concomitantly with Amoxicillin IV and Cloxacillin IV for ≥48 hours between January 1, 2016 and December 31, 2020.
- Patient not having expressed his opposition, after information, to the reuse of his data for scientific research purposes.
Key exclusion criteria (2 listed)
- Subject having expressed opposition to participating in the study
- Subject under guardianship, curatorship or safeguard of justice
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
Description of patients treated with dual IV therapy combining cloxacillin and amoxicillin in high doses at Strasbourg University Hospital
Time frame: Files analysed retrospectively from January 01, 2016 to December 31, 2020 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
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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.
Saïd CHAYER, PhD, HDR contact
Yvon RUCH, MD principal investigator
Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg
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 Endocarditis and Acute Kidney Injury, run by University Hospital, Strasbourg, France 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 3 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: status not confirmed, as of the sponsor's last update on 3 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yvon RUCH, MD (33 3 88 11 66 90, yvon.ruch@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of patients treated with dual IV therapy combining cloxacillin and amoxicillin in high doses at Strasbourg University Hospital (time frame: Files analysed retrospectively from January 01, 2016 to December 31, 2020 will be examined]). 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 3 Dec 2021.