← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed 2 years post intervention
Awards & highlights

VA INTREPID 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.Check my eligibility
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.See study design
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.

VA INTREPID Trial Eligibility Criteria

Inclusion Criteria

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

VA INTREPID Trial 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

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

VA INTREPID 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
1,609 Previous Clinical Trials
3,305,549 Total Patients Enrolled
22 Trials studying Diabetes
12,730 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I become a volunteer for this scientific investigation?

"To be eligible for this research project, applicants must have osteomyelitis and should fall within the age group of 18-89. In total, 880 participants are sought to take part in the trial."

Answered by AI

What ailments have been most effectively treated with Active drug?

"Active drug is widely prescribed to treat MRSA infections and has also been used with some success for the management of pruritus, initial phase tuberculosis, and nasopharynx."

Answered by AI

Has the US Food and Drug Administration granted approval to Active drug?

"There is ample evidence demonstrating the safety of Active drug, thus it scores 3 on our scale. This Phase 4 trial confirms that this medication has been approved for patient use."

Answered by AI

Is this program currently enrolling new participants?

"Indeed, this research project is currently seeking volunteers. It was initially announced on January 22nd 2018 and the most recent update occured on October 21st 2022 according to clinicaltrials.gov."

Answered by AI

Is the age limit for this medical experiment limited to those above 65 years old?

"As indicated by the inclusion criteria, participants aged 18-89 are eligible to apply. In addition, there are 30 studies that can be applied to those under 18 years old and 242 trials available for individuals over 65."

Answered by AI

How extensive is the current involvement in this research endeavor?

"Affirmative. According to the clinicaltrials.gov database, this medical trial is currently enrolling participants and was first posted on January 22nd 2018 before being recently updated on October 21st 2022. 880 patients need to be recruited from 26 different centres around the country."

Answered by AI

How many healthcare organizations are currently carrying out this research in Canada?

"The trial is open to enrolment at 26 different medical centres, namely Washington DC VA Medical Center in Washington; Miami VA Healthcare System in Florida; and the VA Ann Arbor Healthcare System in Michigan. There are also 23 other locales with available spots."

Answered by AI

Could you elaborate on what other investigations have explored the potency of Active drug?

"Currently, there are 31 active clinical trials for Active drug with 11 of them in Phase 3. Of those studies based in Bandung, Alberta, 262 different locations have been established to facilitate the research process."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Florida
Tennessee
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
3+
What site did they apply to?
VA Portland Health Care System, Portland, OR
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Michael E. DeBakey VA Medical Center, Houston, TX

Why did patients apply to this trial?

To learn more about my diabetes. I am praying this clinical trial will help me. I feel so defeated.
PatientReceived 1 prior treatment
I lost leg to hospital made super mersa / ostomilitus. 53 surgery's in 12 years. Bka amputee.
PatientReceived 1 prior treatment
It was presented to me that a trial was being conducted at our local VA, Bay Pines, St. Petersburg, FL.
PatientReceived 2+ prior treatments
Recent research and studies
BMC Infectious DiseasesJournal
A Multicenter Randomized Placebo Controlled Trial of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Veterans with Diabetes (VA INTREPID)
Bessesen, Mary T., Gheorghe Doros, Adam M. Henrie, Kelly M. Harrington, John A. Hermos, Robert A. Bonomo, Ryan E. Ferguson, Grant D. Huang, and Sheldon T. Brown. 2020. “A Multicenter Randomized Placebo Controlled Trial of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Veterans with Diabetes (VA INTREPID)”. BMC Infectious Diseases. Springer Science and Business Media LLC. doi:10.1186/s12879-019-4751-3.
clinicaltrials.govStudy
Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics
2018. "Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03012529.
All > Oklahoma > Utah
~55 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top