A Study to Evaluate Biomarkers of Fluoroquinolone-induced Mitochondrial Toxicity

Overview

About this study

The purposes of this study are to determine if patients treated with fluoroquinolone (FQ) antibiotics have depletion of mitochondrial DNA (mtDNA) in buccal swab samples, and whether the degree of depletion correlates with the likelihood of developing FQ-associated toxicity. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 18 years of age or older.
  • Treatment with oral and/or intravenous FQ antibiotics (ciprofloxacin, levofloxacin, moxifloxacin, delafloxacin) that has been initiated upon, or within 24 hours of, admission to the HIM service or at time of initial Infectious Diseases consultation and lasting > 48 hours.

Exclusion Criteria: 

Any of the following:

  • FQ antibiotic treatment that has been initiated > 24 hours prior to admission that has not yet been completed (e.g., patient is admitted or transferred to HIM or had ID consult when they are already on day 3 of a 7-day course of treatment).
  • Active cancer.
  • Chemotherapy or radiation therapy within the past 6 months.
  • Physical and/or cognitive impairment to the extent that patient cannot be fully assessed for or asked about symptoms of adverse reactions associated with fluoroquinolones.
  • Currently pregnant.
  • Blood transfusion within the past 4 months.
  • Previous bone marrow or organ transplant.
  • Currently on nucleoside reverse transcriptase inhibitors.
  • Pre-existing mitochondrial disease.
  • < 18 years of age.
  • Prior treatment with FQs within 1 week of admission.
  • Active history of routine alcohol use.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Linda Hasadsri, M.D., Ph.D.

Open for enrollment

Contact information:

Katelyn Reed B.S., M.H.S.

(507)284-0503

Reed.Katelyn@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20464386

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