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Incidence, Risk Factors and Impact on Renal Function of the Appearance of Crystalluria Under High-dose Intravenous Amoxicillin

NCT02853292 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 153

Last updated 2022-06-06

No results posted yet for this study

Summary

Intravenous high-dose amoxicillin is a frequently prescribed antibiotic in intensive care units and infectious disease departments, in such indications as meningitis, endocarditis, listeriosis, or documented susceptible osteo-articular infections.

Among possible side effects is the occurrence of amoxicillin crystalluria. Its incidence is unknown. It is deemed uncommon but literature is poor and its incidence is probably under-estimated. It can be complicated with hematuria or acute renal failure and may require renal replacement therapy. measures that can limit the impact of this nephrology crystalluria.

Since the beginning of 2014, because of the occurrence of a case of macroscopic crystalluria in our unit and a pharmacovigilance alert, it has been decided to search systematically for amoxicillin crystalluria in several centers of the north-east of France. The investigators propose to study these patients, through an observational study of a multicenter longitudinal cohort, to assess the incidence of amoxicillin crystalluria during high dose intravenous amoxicillin treatment.

Conditions

  • Amoxicillin Crystalluria

Interventions

BIOLOGICAL

urine collection

Sponsors & Collaborators

  • CHU de Reims

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-08-31
Completion
2022-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02853292 on ClinicalTrials.gov