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Table 3 Study population

From: A multicenter randomized placebo controlled trial of rifampin to reduce pedal amputations for osteomyelitis in veterans with diabetes (VA INTREPID)

Inclusion Criteria:

Men and Women age ≥ 18 and ≤ 89 years

Diabetes Mellitus

Defined either by: 1) use of oral hypoglycemic agents or insulin at the time of enrollment; or 2) a hemoglobin A1c (HgA1c) level within the past 90 days >6.5

Definite or probable osteomyelitis of the foot (DFO)

Defined by the International Working Group on the Diabetic Foot (Table 1)

All planned debridement has been completed prior to randomization

A definitive course of backbone antibiotic treatment has been selected

Exclusion Criteria:

Patient is unable to receive enteral medication

Patient is allergic to or intolerant of rifampin

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

Within 30 days of enrollment, patient is taking immunosuppressive medications to prevent rejection of an organ transplant or is receiving chemotherapy or molecularly targeted therapies for cancer

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

Enrollment in another trial of a therapeutic agent with a documented or suspected interaction with rifampin

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; patient has Child-Pugh Class C Cirrhosis.

Patient has a baseline white blood cell count (WBC) <2000 cells/mm3 OR platelet count <50,000 cells/mm3 OR hemoglobin <8.0 g/dL.

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

Patient is believed unlikely to be able to complete the trial due to medical conditions such as metastatic cancer or end-stage organ failure

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

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

Patient’s prescribed backbone antibiotic therapy does not meet standard of care for either empirical treatment or culture-directed therapy

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

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