Comparison Between Two Durations of Antibiotherapy for Non-surgically-treated Diabetic Foot Osteomyelitis (CHRONOS-2)
NCT ID: NCT05074147
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2022-05-01
2026-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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3 weeks antibiotherapy
Patients are treated 3 weeks with appropriate antibiotics after antibiogram evaluation.
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
6 weeks antibiotherapy
Patients are treated 6 weeks with appropriate antibiotics after antibiogram evaluation.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Tourcoing Hospital
OTHER
Responsible Party
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Principal Investigators
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Eric M SENNEVILLE, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier de Tourcoing
Locations
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Centre Hospitalier de Béthune-Beuvry
Béthune, , France
AP-HP Ambroise Paré
Boulogne-Billancourt, , France
Centre Hospitalier de Boulogne-sur-Mer
Boulogne-sur-Mer, , France
Centre Hopitalier Universitaire de Brest
Brest, , France
Centre Hospitalier Universitaire de Caen
Caen, , France
Centre Hospitalier de Compiègne-Noyon
Compiègne, , France
Centre Hospitalier de Dunkerque
Dunkirk, , France
Centre Hospitalier de Lens
Lens, , France
Centre Hospitalier Universitaire de Lille
Lille, , France
GHICL Saint-Vincent de Paul
Lille, , France
GHICL Saint-Philibert
Lomme, , France
Centre Hospitalier Universitaire de Montpellier
Montpellier, , France
Centre Hospitalier Universitaire de Nantes
Nantes, , France
AP-HP Cochin
Paris, , France
AP-HP Lariboisière
Paris, , France
Centre Hospitalier de Roubaix
Roubaix, , France
Centre Hospitalier Universitaire de Rouen
Rouen, , France
Centre Hospitalier de Valenciennes
Valenciennes, , France
Countries
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Other Identifiers
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RIPH_2019_04
Identifier Type: -
Identifier Source: org_study_id
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