800-872-2273

Clinical Trials and Studies

Your participation matters. Help us discover and cure!

Contact us at (800) USC-CARE (800-872-2273)

We're sorry, but this trial is no longer enrolling volunteers.

PROSPECTIVE EVALUATION OF BIOMARKERS OF AMINOGLYCOSIDE NEPHROTOXICITY IN ADULT PATIENTS WITH CYSTIC FIBROSIS

Description

Aminoglycoside (a specific classs of antibiotics) are a key component of antibiotic therapy for treatment of acute lung infections in patients with cystic fibrosis. One of the major limiting factors associated with the aminoglycosides use is kidney damage. Although blood creatinine levels are frequently monitored, significant elevations only appear after substantial kidney damage has already occurred. The purpose of the study will evaluate the sensitivity and specificity new kidney blood and urine tests on identification of kidney damage. The study population is adult patients with cystic fibrosis that will be recruited to participate: 1) participants hospitalized for treatment of an acute lung infection and prescribed a beta-lactam (specific class of antibiotics), an aminoglycoside or fluoroquinolone antibiotic, and 2) outpatient controls (CF partcipants not experiencing a lung infection and not receiving intravenous antibiotics). These are the control subjects.Participants will be grouped into one of 3 arms of the study. A- beta-lactam and aminoglycoside, B-beta-lactam and fluroquinolone, C-No antibiotic stable CF participants.The study endpoint is to determine the sensitivity, specificity, and negative and positive predictive value of the new kidney blood/urine tests called a biomarkers. The kidney biomarkers may help in early identification of kidney injury in patients receiving aminoglycoside antibiotics.Statistics: The sensitivity to identify subjects treated with a known kidney damaging drug (aminoglycoside) will be determined sequentially using the pre-specified blinded adjudicated method that incorporates urine biomarker information and the conventional method using only sCr and BUN. The sensitivity of each method is determined as the number of true positives divided by the number of samples from aminoglycoside treated patient (true positives + false negatives). The specificity of each method is determined as the number of true negatives divided by the number of samples from control patients (true negative + false positive).

Phase

N/A

Inclusion and Exclusion Criteria

  • Males and females ≥ 18 years of age.
  • Documentation of CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria: - Sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test. - Two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; or - Abnormal nasal potential difference.
  • Hospitalized and initiated on systemic antibiotic therapy for treatment of an acute pulmonary exacerbation.
  • Willingness and ability to comply with study procedures and study restrictions.
  • Ability to provide written informed consent.

  • Chronic kidney disease defined by microalbuminuria (> 30 mcg/mg creatinine) or eGFR < 60 mL/min/1.73m2.
  • Receiving medications known to alter the tubular secretion of creatinine (e.g. trimethoprim, cimetidine).
  • Hospitalized for treatment of an acute pulmonary exacerbation or received intravenous aminoglycoside antibiotics within 3-months of study entry.

Sites

  • California

    • University of Southern California, Los Angeles, California, 90033
  • Utah

    • University of Utah, Salt Lake City, Utah, 84132
  • Minnesota

    • University of Minnesota - Cystic Fibrosis Center, Minneapolis, Minnesota, 55455
Powered by SC CTSI