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Antibiotic

Rifampin for Osteomyelitis in Diabetics (VA INTREPID Trial)

Phase 4
Recruiting
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Must not have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed 2 years post intervention
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is testing whether adding the antibiotic rifampin to the usual treatment for osteomyelitis (bone infection) reduces the risk for amputations in diabetic patients.

Who is the study for?
Adults aged 18-89 with diabetes and foot osteomyelitis, who've completed debridement and selected a backbone antimicrobial therapy. Excluded are those unable to take oral meds, allergic to rifampin, at medical risk due to drug interactions, on immunosuppressants or certain cancer therapies, pregnant women, unlikely to complete the trial due to health/behavioral issues, with specific low blood counts or liver function abnormalities.
What is being tested?
The study is testing whether adding rifampin to standard antibiotics can reduce the need for amputations in diabetic patients with foot osteomyelitis. Participants will either receive rifampin or a placebo alongside their regular antibiotic treatment.
What are the potential side effects?
Rifampin may cause side effects like upset stomach, heartburn, nausea, menstrual changes in women; more serious but less common effects include flu-like symptoms, significant fatigue or weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a bone infection in my foot due to diabetes within the last 90 days.
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I have diabetes as shown by my medication, recent HgA1c levels, or past diagnoses.
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All my scheduled tissue removal surgeries are done.
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I have chosen a specific antimicrobial treatment plan.
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I am between 18 and 89 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on immunosuppressants for an organ transplant or receiving cancer treatment.
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My liver tests are significantly abnormal, or I have severe liver disease.
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I cannot take medicine by mouth.
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I am a woman who could become pregnant and my pregnancy test is positive.
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I have metal or plastic parts inside my foot due to bone infection.
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I am on medication for HIV or Hepatitis C.
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I cannot or do not want to have the suggested surgical cleaning of a wound.
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I am on COVID-19 treatment that interacts with rifampin.
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I am on antibiotics for an infection expected to last more than 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed 2 years post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed 2 years post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Amputation-Free Survival
Secondary study objectives
Ambulatory Status
Comparative dropout
Complete epithelialization of the wound
+8 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active drugActive Control1 Intervention
Patients receive oral adjunctive rifampin therapy
Group II: PlaceboPlacebo Group1 Intervention
Patients receive oral riboflavin

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,764,986 Total Patients Enrolled
22 Trials studying Diabetes
11,976 Patients Enrolled for Diabetes
Mary T Bessesen, MDStudy ChairRocky Mountain Regional VA Medical Center, Aurora, CO
1 Previous Clinical Trials
1 Total Patients Enrolled

Media Library

Rifampin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03012529 — Phase 4
Diabetes Research Study Groups: Active drug, Placebo
Diabetes Clinical Trial 2023: Rifampin Highlights & Side Effects. Trial Name: NCT03012529 — Phase 4
Rifampin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03012529 — Phase 4
Diabetes Patient Testimony for trial: Trial Name: NCT03012529 — Phase 4
~86 spots leftby Sep 2025
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