NCT05074147

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

Three Weeks Versus Six Weeks Antibiotic Therapy for Nonsurgically Treated Diabetic Foot Osteomyelitis : a Multicenter, Randomized, Open-label and Controlled Study

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Tourcoing Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteomyelitis - Foot

Interventions

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

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-11-01
• Completion: 2026-11-01
• First posted: 2021-10-12
• Last updated: 2026-01-14

Locations

18 sites across 1 country: France