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

NCT05074147 | Withdrawn Phase 3

• 1 other identifier: RIPH_2019_04
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 18

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.

Conditions

Osteomyelitis - Foot

Keywords

Diabetes Mellitus; Antibiotic Treatment

Outcome Measures

Primary Outcomes (1)

• Percentage of treated patients achieving remission from the diabetic foot osteomyelitis at the end of follow-up

  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.

  12 months

Secondary Outcomes (7)

• Time needed for a complete wound healing in each group.

  12 months

• 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 occurrence of a peripheral neuroathropathy (Charcot foot) in each group of patients.

  12 months

Study Arms (2)

3 weeks antibiotherapy

EXPERIMENTAL

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

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

6 weeks antibiotherapy

EXPERIMENTAL

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

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

Interventions

Reduction in the duration of antibiotic therapy 3 weeks or 6 weeks DRUG

Drugs : * Rifampin (IP an PO) : 10mg/Kg/12h * Ofloxacin (PO) : 200Mg/8h * Levofloxacin (PO) : 500mg ot 1g/ twice a day * Ciprofloxacin : IV : 400mg/8h if Pseud spp ; 400mg/12h for others Gram-negative bacilli strains; PO : 1gr/12h if Pseud spp ; 750mg/12h for others Gram-negative bacilli strains * Clindamycin : 600-900mg/8h * Fusidic Acid : 500mg/8h * Teicoplanin : 10mg/kg/12h for 5 dosis in combination, then in monotherapy. * Ceftasidim : 2g/8h if Pseud spp ; 2g/12h for others Gram-negative bacilli strains * Trimethoprim-sulfamethoxazole (800mg/160mg) : once per day if patient \< 80Kg ; one and a half per day if patient \> 80Kg. * Doxycyclin : 200mg/day * Minocyclin : 100mg/8h to 12h * Ceftriaxon : 1g to 2g/day in IV, IM or SC * Cefotaxim : 1g to 2g/day in IV * Pristinamycin : 1g thrice a day

3 weeks antibiotherapy; 6 weeks antibiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tourcoing Hospital: lead

Study Sites (18)

Centre Hospitalier de Béthune-Beuvry

Béthune, France

Location

AP-HP Ambroise Paré

Boulogne-Billancourt, France

Location

Centre Hospitalier de Boulogne-sur-Mer

Boulogne-sur-Mer, France

Location

Centre Hopitalier Universitaire de Brest

Brest, France

Location

Centre Hospitalier Universitaire de Caen

Caen, France

Location

Centre Hospitalier de Compiègne-Noyon

Compiègne, France

Location

Centre Hospitalier de Dunkerque

Dunkirk, France

Location

Centre Hospitalier de Lens

Lens, France

Location

Centre Hospitalier Universitaire de Lille

Lille, France

Location

GHICL Saint-Vincent de Paul

Lille, France

Location

GHICL Saint-Philibert

Lomme, France

Location

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, France

Location

AP-HP Cochin

Paris, France

Location

AP-HP Lariboisière

Paris, France

Location

Centre Hospitalier de Roubaix

Roubaix, 59100, France

Location

Centre Hospitalier Universitaire de Rouen

Rouen, France

Location

Centre Hospitalier de Valenciennes

Valenciennes, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Eric M SENNEVILLE, MD, PhD

  Centre Hospitalier de Tourcoing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: May 1, 2022
• Primary Completion: November 1, 2024
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (18)