ACTIVE_NOT_RECRUITING

Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research study is to determine if rifampin, an antibiotic (a medicine that treats infections), is effective in treating osteomyelitis (infection of the bone) of the foot in diabetic patients. Despite use of powerful antibiotics prescribed over a long period of time, many diabetic patients remain at a high risk for needing an amputation of part of the foot or lower leg because the osteomyelitis is not cured. Some small research studies have shown that addition of rifampin to other antibiotics is effective in treating osteomyelitis in both diabetics and non-diabetics. However, because few diabetics with osteomyelitis have been studied, there is no definite proof that it is better than the usual treatments for diabetic patients. If this study finds that adding rifampin to the usual antibiotics prescribed for osteomyelitis reduces the risk for amputations, doctors will be able to more effectively treat many Veteran patients with this serious infection. Improving treatment outcomes is an important healthcare goal of the VA.

Official Title

CSP #2001 - Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics (VA Intrepid)

Quick Facts

Study Start:2018-01-22
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03012529

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18 and 89 years
  2. 2. Diagnosis of diabetes mellitus, either by: 1) use of oral hypoglycemic agents or insulin at the time of enrollment; 2) a hemoglobin A1c (HgA1c) level within the past 90 days \> 6.5; or 3) a medical record diagnosis of diabetes mellitus by a clinician on two or more occasions in the previous 10 years
  3. 3. Definite or probable osteomyelitis in the diabetic foot, as defined by the International Working Group on the Diabetic Foot (Table 1). Criteria must be present at some point within 90 days prior to enrollment.
  4. 4. All planned debridement has been completed prior to randomization.
  5. 5. A course of backbone antimicrobial therapy has been selected.
  1. 1. Patient unable to receive enteral medication.
  2. 2. Patient is allergic to or intolerant of rifampin.
  3. 3. Patient is taking a drug that has interactions with rifampin that would require either stoppage, substitution or an empiric dose modification that may place the patient at medical risk.
  4. 4. Within 30 days of enrollment, patient is taking immunosuppressive medications to prevent rejection of an organ transplant or is receiving chemotherapy for cancer or molecularly targeted therapies for cancer.
  5. 5. Patient is receiving antiretroviral therapy for HIV or antiviral medication for Hepatitis C.
  6. 6. Patient is participating in another interventional clinical trial for which a waiver of dual enrollment with CSP#2001 has not been obtained.
  7. 7. Patient has an ALT \> 3 times the upper limit of normal for the site laboratory, or total bilirubin \> 2.5 times the upper limit of normal for the site laboratory\*,\*\*\*; INR \> 1.5, OR patient has Child-Pugh Class C Cirrhosis.
  8. 8. Patient has a baseline white blood cell count (WBC) \<2000 cells/mm3\*\*\* OR absolute neutrophil count (ANC) \<1000 cells/mm3\*\*\* OR platelet count \<50,000 cells/mm3\*\*,\*\*\* OR hemoglobin \<8.0 g/dL.\*\*,\*\*\*.
  9. 9. Women of child-bearing potential (those with menses within the last year) with a positive serum pregnancy test.
  10. 10. Patient is believed unlikely to be able to complete the trial due to medical conditions.
  11. 11. Patient is believed unlikely to complete the trial due to neurologic and psycho-behavioral disorders such as active substance abuse or dependence, disabling dementias or psychoses.
  12. 12. Patient refuses or is clinically unable to undergo the recommended level of debridement.
  13. 13. Indwelling hardware present in the foot, at the site of the index osteomyelitis.
  14. 14. Treatment with antibacterial agents for infection at another site, where the duration of treatment is anticipated to be greater than 14 days.
  15. 15. Patient is receiving therapy for COVID-19 that interacts with rifampin.
  16. * Patients with total bilirubin \> 2 times the ULN who have Gilbert's Disease or any other inherited disease affecting bilirubin metabolism without meeting other exclusionary criteria, may be considered for inclusion in the study.
  17. * Patients with platelet count \<50,000 cells/mm3 due only to hypersplenism and meeting no other exclusionary criteria may be considered for inclusion in the study.
  18. * If multiple laboratory values are available, the most recent value will be applied for eligibility.

Contacts and Locations

Principal Investigator

Mary T Bessesen, MD
STUDY_CHAIR
Rocky Mountain Regional VA Medical Center, Aurora, CO

Study Locations (Sites)

Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, 85012
United States
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, 92357-1000
United States
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
United States
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
United States
VA Northern California Health Care System, Mather, CA
Sacramento, California, 95655
United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
United States
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
United States
Washington DC VA Medical Center, Washington, DC
Washington, District of Columbia, 20422-0001
United States
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, 33744-0000
United States
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135
United States
Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125
United States
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
United States
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
United States
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
Saint Louis, Missouri, 63106
United States
James J. Peters VA Medical Center, Bronx, NY
Bronx, New York, 10468-3904
United States
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Salisbury, North Carolina, 28144
United States
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, 45220
United States
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
United States
Dayton VA Medical Center, Dayton, OH
Dayton, Ohio, 45428
United States
Oklahoma City VA Medical Center, Oklahoma City, OK
Oklahoma City, Oklahoma, 73104
United States
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
United States
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
United States
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229
United States
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001
United States
Salem VA Medical Center, Salem, VA
Salem, Virginia, 24153-6404
United States
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Mary T Bessesen, MD, STUDY_CHAIR, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-01-22
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2018-01-22
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Rifampin
  • Double-blind
  • Clinical Trial
  • Veterans
  • Diabetes

Additional Relevant MeSH Terms

  • Osteomyelitis
  • Diabetes
  • Amputation