MedDataX Logo

Renal Tolerance of Amoxicillin and Cloxacillin Combination

NCT ID: NCT05142891

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endocarditis Acute Kidney Injury

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Endocarditis Acute kidney injury Amoxicillin Cloxacillin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* Subject having expressed opposition to participating in the study
* Subject under guardianship, curatorship or safeguard of justice
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yvon RUCH, MD

Role: PRINCIPAL_INVESTIGATOR

Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yvon RUCH, MD

Role: CONTACT

Phone: 33 3 88 11 66 90

Email: [email protected]

Saïd CHAYER, PhD, HDR

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yvon RUCH, MD

Role: primary

Saïd CHAYER, PhD, HDR

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

8411

Identifier Type: -

Identifier Source: org_study_id