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.
Age ≥ 18 years
Able to give informed consent without the intervention of a legal representative
Treatment with
sulfamethoxazole/trimethoprim, with minimum dose of
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
Single group
Crystalluria examination
Diagnostic testCrystalluria examination
Incidence of drug-induced crystalluria in patients treated with sulfamethoxazole
The presence of sulfamethoxazole-induced crystalluria will be evaluated by microscopic crystalluria examination in first voided morning urine samples on day 3, 7 and 11 after start of treatment and will be reported as a dichotomous parameter (present/absent).
Incidence of drug-induced crystalluria in patients treated with high dose ciprofloxacin
The presence of ciprofloxacin-induced crystalluria will be evaluated by microscopic cyrstalluria examination in first voided morning urine samples on day 3 and 7 after start of treatment and will be reported as a dichotomous parameter (present/absent).
Incidence of drug-induced crystalluria in patients treated with high dose iv amoxicillin
The presence of amoxicillin-induced crystalluria will be evaluated by microscopic cyrstalluria examination in first voided morning urine samples on day 2, 4, 6, 8 and 11 after start of treatment and will be reported as a dichotomous parameter (present/absent).
Incidence of AKI in patients treated with high dose iv amoxicillin
Acute kidney injury is defined as an increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours or ≥ 1.5 times baseline within the prior 7 days. The occurrence of acute kidney injury will be performed by calculating the difference between serum creatinine at baseline and during antibiotic treatment at 4 different moments after start of antibiotic treatment, namely day 1-3, day 4-7, day 8-11 and day 12-14.
Incidence of AKI in patients treated with sulfamethoxazole
Acute kidney injury is defined as an increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours or ≥ 1.5 times baseline in association with a concomitant rise of serum urea of 22 mg/dl within 48 hours or ≥ 1.5 times base-line within the prior 7 days. The occurrence of acute kidney injury will be performed by calculating the difference between serum creatinine and serum urea at baseline and during antibiotic treatment at 3 different moments after start of antibiotic treatment, namely day 1-4, day 5-9, day 8-11 and day 10-14.
Incidence of AKI in patients treated with high dose ciprofloxacin
Acute kidney injury is defined as an increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours or ≥ 1.5 times baseline within the prior 7 days. The occurrence of acute kidney injury will be performed by calculating the difference between serum creatinine at baseline and during antibiotic treatment at 2 different moments after start of antibiotic treatment, namely day 3-7 and day 8-12. By this we will evaluated if the occurrence of ciprofloxacin-induced crystalluria is associated with an increased risk of incident AKI development in patients treated with high dose ciprofloxacin.
Identification of demographic, clinical and biochemical factors associated with the development of drug-induced crystalluria
Identification of demographic, clinical and biochemical factors associated with the development of drug-induced crystalluria by means of repeated measures logistic regression modelling
Time interval between start of antibiotic treatment and development of sulfamethoxazole, ciprofloxacin and amoxicillin crystalluria
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