Comparison Between Two Durations of Antibiotherapy for Non-surgically-treated Diabetic Foot Osteomyelitis (CHRONOS-2)

Tourcoing Hospital

Status and phase: Withdrawn; Phase 3

Conditions: Osteomyelitis - Foot

Treatments: Drug: Reduction in the duration of antibiotic therapy 3 weeks or 6 weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT05074147

RIPH_2019_04

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 D1.
• 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.
• Gangrene
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

3 weeks antibiotherapy

Experimental group

Description:

Patients are treated 3 weeks with appropriate antibiotics after antibiogram evaluation.

Treatment:

Drug: Reduction in the duration of antibiotic therapy 3 weeks or 6 weeks

6 weeks antibiotherapy

Experimental group

Description:

Patients are treated 6 weeks with appropriate antibiotics after antibiogram evaluation.

Treatment:

Drug: Reduction in the duration of antibiotic therapy 3 weeks or 6 weeks