Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics


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Trial ID: NCT03012529


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)

Stanford Investigator(s)


Inclusion Criteria:

   1. Age 18 and 89 years

   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. 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. All planned debridement has been completed prior to randomization.

   5. A course of backbone antimicrobial therapy has been selected.

Exclusion Criteria:

   1. Patient unable to receive enteral medication.

   2. Patient is allergic to or intolerant of rifampin.

   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. 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. Patient is receiving antiretroviral therapy for HIV or antiviral medication for
   Hepatitis C.

   6. Patient is participating in another interventional clinical trial for which a waiver
   of dual enrollment with CSP#2001 has not been obtained.

   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. 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. Women of child-bearing potential (those with menses within the last year) with a
   positive serum pregnancy test.

10. Patient is believed unlikely to be able to complete the trial due to medical

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. Patient refuses or is clinically unable to undergo the recommended level of

13. Indwelling hardware present in the foot, at the site of the index osteomyelitis.

14. Treatment with antibacterial agents for infection at another site, where the duration
   of treatment is anticipated to be greater than 14 days.

15. Patient is receiving therapy for COVID-19 that interacts with rifampin.

      - 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.

         - 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.

            - If multiple laboratory values are available, the most recent value will
            be applied for eligibility.


drug: Rifampin

drug: Riboflavin Placebo


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mark Holodniy, MD