Drug-induced Crystalluria and Kidney Injury in Hospitalized Patients on Sulfamethoxazole, High-Dose Ciprofloxacin, or High-Dose Amoxicillin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective study observes hospitalized patients treated with either sulfamethoxazole/trimethoprim, high-dose ciprofloxacin, or high-dose IV amoxicillin. Urine samples are collected on predefined days to detect drug-induced crystals, and kidney function is monitored over time. The goal is to describe the incidence of crystalluria, its timing, and its association with AKI, while also exploring factors that may influence risk. Data will include demographic, clinical, and laboratory information to identify potential predictors. The study does not compare treatments but focuses on crystal formation and kidney outcomes within each antibiotic exposure group.

Why it matters

Who can join: the full rules

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

Where it's running

• Universitair Ziekenhuis Brussel
  Brussels, Belgium Recruiting

Study contacts

• Study coordinator: Els Van de Perre, MD
• Email: els.vandeperre@uzbrussel.be
• Phone: 0032 2 477 60 55

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.