Study Using Clofazimine to Treat Patients with Non-Tuberculous Mycobacterial Infections

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Scottsdale/Phoenix, Arizona: 18-008821
    Sponsor Protocol Number: CLAM320B2002M

About this study

The purpose of this study is to determine whether adding clofazimine in a treatment regimen for patients with non-tuberculous mycobacterial (NTM) infections will improve low clinical success rates in NTM infections, its mode of action, and literature reported clinical data in both NTM and multidrug-resistant tuberculosis.

 

 

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

Patients eligible for inclusion in this program have to fulfill all of the following criteria:

  • Male or female patients 18 years of age or older.
  • Written informed consent must be obtained before any project specific assessment is performed.
  • Patients previously diagnosed with NTM infection with local or disseminated infection (i.e., patients with any NTM species at any site of infection).
  • Patients who failed or are intolerant of prior therapies or who have baseline macrolide resistance or for whom an appropriate regimen cannot otherwise be devised.
  • Male patients (including vasectomized patients) who agree to use a condom during intercourse while taking clofazimine treatment and for at least 4 months after stopping treatment with clofazimine.
  • Female patients of child-bearing potential with negative pregnancy test before clofazimine treatment initiation and who confirm no intention to become pregnant during the treatment with clofazimine, by using highly effective methods of contraception (methods that result in less than 1% pregnancy rates) while taking clofazimine treatment and for at least 4 months after stopping treatment with clofazimine.  Examples of highly effective contraception methods include, but are not limited to:
    • Total abstinence (when this is in line with the preferred and usual lifestyle of the subject);
    • Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, postovulation methods) and withdrawal are not acceptable methods of contraception;
    • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment;
    • Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with oral or injected or implanted hormonal contraception or intra-uterine device or with spermicidal foam/gel/film/cream/vaginal suppository;
    • Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have  comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception;
    • Women of child-bearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.

Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for inclusion in this program:

  • History of hypersensitivity to any drugs or metabolites of similar chemical classes as clofazimine.
  • History or current diagnosis of clinically significant ECG abnormalities that pose a safety risk for the patient, such as clinically significant cardiac arrhythmias (e.g., sustained ventricular tachycardia, second or third degree heart block without a pacemaker).
  • History or additional risk factors for Torsades de Pointes such as heart failure, clinically relevant hypokalemia, familial long QT syndrome or known family history of Torsade s de Pointes.
  • Confirmed demonstration of resting QTcF >500 msec at screening.
  • Any condition (social, psychiatric, or medical) which in the opinion of the treating physician would make participation in this MPP unsafe.
  • Unable to swallow capsules.
  • HIV-infected patients with disseminated NTM infection.
  • Life expectancy less than 6 months.
  • Pregnant or nursing (lactating) females.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Juan Gea Banacloche, M.D.

Contact us for the latest status

Contact information:

Angela Eyshou CCRP

(480)342-3906

Eyshou.Angela@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available