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Drug-induced Crystalluria in Sulfamethoxazole, High Dose Ciprofloxacin and High Dose Amoxicillin

RecruitingNA

Sponsor: Universitair Ziekenhuis Brussel

Conditions: Drug-induced Crystalline Nephropathy, Drug-induced Crystalluria, Infections Treated With Sulfamethoxazole, High Dose Ciprofloxacin or High Dose iv Amoxicillin

Interventions: Crystalluria examination

Countries: Belgium

This study examines in hospitalized patients, treated with sulfamethoxazole, high dose ciprofloxacin or high dose iv amoxicillin, the incidence of drug-induced urinary crystal formation and its association with acute kidney injury development.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years
* Able to give informed consent without the intervention of a legal representative
* Treatment with
* sulfamethoxazole/trimethoprim, with minimum dose of
* ≥ 800/160 mg q12h oral administration (PO) or intravenous administration (IV) for eGFR ≥ 30 ml/min
* ≥ 400/80 mg q12h OR or IV for eGFR \< 30 ml/min OR
* high dose ciprofloxacin, defined as
* ≥ 750 mg q12h PO or ≥ 400 mg q8h IV for eGFR ≥ 60 ml/min
* ≥ 750 mg q24h PO or ≥ 400 mg q12h IV for eGFR 15-59 m/min
* ≥ 750 mg q24h PO OR ≥ 400 mg q24h IV for eGFR \< 15 ml/min

OR

* high dose amoxicillin, defined as
* ≥ 2g q6h IV for eGFR ≥ 30 ml/min
* ≥ 2g q8h IV for eGFR 15-29 ml/min
* ≥ 2g q12h IV for eGFR \< 15 ml/min
* Treatment for min 24 hours and sufficiently long to perform one crystalluria investigation as defined in the protocol
* Baseline renal function up to 72 hours prior to the start of antibiotic treatment available (evaluated by serum creatinine and eGFR (CKD-EPI)) for all study groups and additional serum urea for the sulfamethoxazole group).

Exclusion Criteria:

* Unable to give informed consent without the intervention of a legal representative
* No baseline renal function up to 72 hours prior to the start of antibiotic treatment available, evaluated by serum creatinine and eGFR (CKD-EPI)) for all study groups and additional serum urea for the sulfamethoxazole group.
* Treatment duration \< 24 hours or insufficiently long to perform one crystalluria inves-tigation as defined in the protocol
* Patients treated with hemodialysis or peritoneal dialysis, anuric patients before start of antibiotic treatment
* Patients with urinary diversions

Locations (1)

Brussels, Belgium