NCT07772752 Drug-induced Crystalluria in Sulfamethoxazole, High Dose Ciprofloxacin and High Dose Amoxicillin
| NCT ID | NCT07772752 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitair Ziekenhuis Brussel |
| Condition | Drug-induced Crystalline Nephropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 290 participants |
| Start Date | 2025-12-08 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 290 participants in total. It began in 2025-12-08 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07772752 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Drug-induced Crystalline Nephropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07772752 currently recruiting?
Yes, NCT07772752 is actively recruiting participants. Contact the research team at els.vandeperre@uzbrussel.be for enrollment information.
Where is the NCT07772752 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT07772752 clinical trial?
NCT07772752 is sponsored by Universitair Ziekenhuis Brussel. The trial plans to enroll 290 participants.