Clinical trial NCT05074147: Comparison Between Two Durations of Antibiotherapy for Non-surgically-treated Diabetic Foot Osteomyelitis (CHRONOS-2)
Official title: Three Weeks Versus Six Weeks Antibiotic Therapy for Nonsurgically Treated Diabetic Foot Osteomyelitis : a Multicenter, Randomized, Open-label and Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Osteomyelitis - Foot
Keywords: Diabetes Mellitus
Antibiotic Treatment
Lead sponsor: Tourcoing Hospital
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of treated patients achieving remission from the diabetic foot osteomyelitis at the end of follow-up
timeFrame: 12 months
Secondary outcomes:
measure: Comparison in each group of patients of the time needed for a complete wound healing.
timeFrame: 12 months
measure: Rates of reinfection at the initial site in each group of patients.
timeFrame: 12 months
measure: Rates of occurrence of a new wound after healing, on the same site initially traited in each group of patients.
timeFrame: 12 months
measure: Rates of occurrence of a new wound after healing on the same foot but not the same infection site in each group of patients.
timeFrame: 12 months
measure: Rates of occurrence of a peripheral neuroathropathy (Charcot foot) in each group of patients.
timeFrame: 12 months
measure: Rates of amputation in each group of patients.
timeFrame: 12 months
measure: Rates of major amputation in each group of patients.
timeFrame: 12 months
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: AP-HP Ambroise Paré
city: Boulogne-sur-Mer
country: France
facility: Centre Hospitalier de Boulogne-sur-Mer
city: Brest
country: France
facility: Centre Hopitalier Universitaire de Brest
city: Béthune
country: France
facility: Centre Hospitalier de Béthune-Beuvry
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen
city: Compiègne
country: France
facility: Centre Hospitalier de Compiègne-Noyon
city: Dunkerque
country: France
facility: Centre Hospitalier de Dunkerque
city: Lens
country: France
facility: Centre Hospitalier de Lens
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Lille
country: France
facility: GHICL Saint-Vincent de Paul
city: Lomme
country: France
facility: GHICL Saint-Philibert
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Paris
country: France
facility: AP-HP Cochin
city: Paris
country: France
facility: AP-HP Lariboisière
city: Roubaix
country: France
facility: Centre Hospitalier de Roubaix
city: Rouen
country: France
facility: Centre Hospitalier Universitaire de Rouen
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes
Study officials:
affiliation: Centre Hospitalier de Tourcoing
name: Eric M SENNEVILLE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: