Three Weeks Versus Six Weeks Antibiotic Therapy for Nonsurgically Treated Diabetic Foot Osteomyelitis : a Multicenter, Randomized, Open-label and Controlled Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Enrollment
- 280
- Locations
- 18
- Primary Endpoint
- Percentage of treated patients achieving remission from the diabetic foot osteomyelitis at the end of follow-up
Study Overview
Brief Summary
The aim of this clinical study is to compare the efficacy and tolerance of 3 versus 6 weeks of antibiotherapy in patients with diabetic foot osteomyelitis treated medically.
Detailed Description
The fight against multi-drug resistant bacteria is a global matter and a major health public issue. The excessive exposure of microorganisms to drugs increases their ability to develop survival mechanisms, causing an emerging threat and a health challenge.
Several recent studies showed that 18-35% of patients with diabetic foot infections harbored multiply drug-resistance to organisms (MDRO), the most common is Staphylococcus aureus (MRSA). Hospitalization, surgical procedures and long antibiotic therapy induce the development of MDRO or MRSA In diabetic foot, Osteomyelitis (DFO) is a well recognize risk factor for major amputation and mortality rates that occurs in more than 20% of moderate infections and 50% to 60 % of severe infections. In this context, the aim of this study is to evaluated that reducing time of antibiotic administration (3 weeks) is not substantially worse than the current treatment guidelines (6 weeks) in DFO managed nonsurgically.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient aged ≥ 18 years
- •Informed, written consent obtained from patient
- •Patient having the rights to Frenc social insurrance
- •For women of childbearing potential : any effective contraceptive is required
- •Type 1 or 2 diabetic patients
- •Diabetic patients treated non-surgically for an osteomyelitis of the forefoot affecting only one osteoarticular part/radial supported by adequate diagnostic imaging and bone biopsy performed through uninfected tissue.
- •Two peripheral pulses or transcutaneous oxygen tension measurement (TcPO2 > 30mmHg) or ankle brachial index (ABI > 0.9)
- •Patient without antibiotherapy during 2 weeks before D
- •Glycated hemoglobin (HbA1C) < 12% ( measured maximum 2 months before D1)
- •Use of offloading boot for diabetic foot is feasible
Exclusion Criteria
- •Bone fragmentation, articular destruction requiring bone resection or amputation.
- •More than one osteoarticular part/radial affected
- •Contraindication for the use of offloading boot
- •Contraindication for bone biopsy
- •Contraindication for the full course of antibiotics (allergy or based on RCP)
- •Other drug-drug interaction that contraindicated the full course of antibiotics
- •Charcot foot
- •Patient undergoing radiotherapy of chimiotherapy for malignant neoplasms
- •Hepatic insufficiency (ASAT and/or ALAT > 3 times the normal level)
- •Any disease or behaviour making impossible to follow the protocol or difficult to interpret the results
- •Any disease or context making difficult to allow regular monitoring of the patient
- •Participation in other interventional research during the study
- •Curator or guardianship of patient placed under judicial protection
- •Pregnancy or lactating women
Arms & Interventions
3 weeks antibiotherapy
Patients are treated 3 weeks with appropriate antibiotics after antibiogram evaluation.
Intervention: Reduction in the duration of antibiotic therapy 3 weeks or 6 weeks (Drug)
6 weeks antibiotherapy
Patients are treated 6 weeks with appropriate antibiotics after antibiogram evaluation.
Intervention: Reduction in the duration of antibiotic therapy 3 weeks or 6 weeks (Drug)
Outcomes
Primary Outcomes
Percentage of treated patients achieving remission from the diabetic foot osteomyelitis at the end of follow-up
Time Frame: 12 months
Remission is defined as one of following events : * No relapse of infection at the initial or a contiguous site leading to make a new antibiogram. * Absence of pathology exacerbation visible by radiological results (comparison with Day 0) * Absence of orthopedic surgery or amputation of the foot infected initially.
Secondary Outcomes
- Rates of reinfection at the initial site in each group of patients.(12 months)
- Rates of occurrence of a new wound after healing, on the same site initially traited in each group of patients.(12 months)
- Rates of occurrence of a new wound after healing on the same foot but not the same infection site in each group of patients.(12 months)
- Rates of major amputation in each group of patients.(12 months)
- Rates of occurrence of a peripheral neuroathropathy (Charcot foot) in each group of patients.(12 months)
- Rates of amputation in each group of patients.(12 months)
- Time needed for a complete wound healing in each group.(12 months)