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

NCT02853292 | Completed

• 1 other identifier: PO16055
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Occurrence of amoxicillin crystalluria, assessed by urine microscopic direct examination

  Judgement criterion measure is done at the 3rd, 7th and 14th day of intravenous high dose amoxicillin therapy, on the first morning urine, or during an episode of acute renal failure or hematuria

  up to 14 days of intravenous high dose amoxicillin therapy

Study Arms (1)

amoxicillin crystalluria

Biological: urine collection

Interventions

urine collection BIOLOGICAL

amoxicillin crystalluria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients included will be all consecutive 18 years old or more patients for which treatment by IHDA (\> 150mg / kg / day) has been initiated in a unit participating in the study or within 48 hours before admission to this unit. Patients will be from the following units: * Internal Medicine - Infectious Disease, Clinical Immunology - University Hospital of Reims * Nephrology Unit - University Hospital of Reims * Intensive Care Unit - Univerity Hospital of Reims * Infectious Diseases Unit - Nancy University Hospitals * Infectious Diseases Unit - Dijon University Hospitals * Infectious Diseases Unit - Troyes hospital * Infectious Diseases Unit - Chalon sur Saone Hospital -- Infectious Diseases Unit - Charleville-Mézières Hospital - - Intensive Care Unit - Charleville-Mézières Hospital

You may qualify if:

• The patients included will be all patients aged 18 years or more consecutive for which treatment by IHDA (\> 150mg / kg / day) has been initiated in a unit participating in the study or within 48 hours before admission to this Service .
• Patients on dialysis or kidney transplant receiver will not be included.

You may not qualify if:

• Patients who did not receive treatment until at least the first urine direct examination and patients for whom it is not feasible for technical reasons will also be excluded.

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

Related Publications (1)

• Demotier S, Limelette A, Charmillon A, Baux E, Parent X, Mestrallet S, Pavel S, Servettaz A, Drame M, Muggeo A, Wynckel A, Gozalo C, Taam MA, Fillion A, Jaussaud R, Trenque T, Piroth L, Bani-Sadr F, Hentzien M; CRISTAMOX Study group. Incidence, associated factors, and effect on renal function of amoxicillin crystalluria in patients receiving high doses of intravenous amoxicillin (The CRISTAMOX Study): A cohort study. EClinicalMedicine. 2022 Mar 12;45:101340. doi: 10.1016/j.eclinm.2022.101340. eCollection 2022 Mar.

  PMID: 35295665 DERIVED

MeSH Terms

Interventions

Urine Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 2, 2016
• Study Start: May 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: May 1, 2022
• Last Updated: June 6, 2022

Record last verified: 2022-06

Locations

FR (1)