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

NCT05074147 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2026-01-14

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Tourcoing Hospital

    lead OTHER

Principal Investigators

  • Eric M SENNEVILLE, MD, PhD · Centre Hospitalier de Tourcoing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2024-11-30
Completion
2026-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05074147 on ClinicalTrials.gov