Osteomyelitis - FootPhase 3CHRONOS-2NCT05074147
Comparison Between Two Durations of Antibiotherapy for Non-surgically-treated Diabetic Foot Osteomyelitis (CHRONOS-2)
A Phase 3 study testing Reduction in the duration of antibiotic therapy 3 weeks or 6 weeks in people with Osteomyelitis - Foot, run by Tourcoing Hospital at 18 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteomyelitis - Foot
- What is being tested?
- Reduction in the duration of antibiotic therapy 3 weeks or 6 weeks
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 18 sitesFrance
- Study dates
- 1 May 2022to Nov 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
Centre Hospitalier de Béthune-Beuvry
Béthune
AP-HP Ambroise Paré
Boulogne-Billancourt
Centre Hospitalier de Boulogne-sur-Mer
Boulogne-sur-Mer
Centre Hopitalier Universitaire de Brest
Brest
Centre Hospitalier Universitaire de Caen
Caen
Centre Hospitalier de Compiègne-Noyon
Compiègne
Centre Hospitalier de Dunkerque
Dunkirk
Centre Hospitalier de Lens
Lens
Centre Hospitalier Universitaire de Lille
Lille
GHICL Saint-Vincent de Paul
Lille
GHICL Saint-Philibert
Lomme
Centre Hospitalier Universitaire de Montpellier
Montpellier
Centre Hospitalier Universitaire de Nantes
Nantes
AP-HP Cochin
Paris
AP-HP Lariboisière
Paris
Centre Hospitalier de Roubaix
Roubaix, 59100
Centre Hospitalier Universitaire de Rouen
Rouen
Centre Hospitalier de Valenciennes
Valenciennes
About this study
Official title: Three Weeks Versus Six Weeks Antibiotic Therapy for Nonsurgically Treated Diabetic Foot Osteomyelitis : a Multicenter, Randomized, Open-label and Controlled Study
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.
Read the 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
- Being tested
- Reduction in the duration of antibiotic therapy 3 weeks or 6 weeks
- Keywords
- Diabetes Mellitus, Antibiotic Treatment
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction in the duration of antibiotic therapy 3 weeks or 6 weeksDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 3 weeks antibiotherapy | Experimental | Patients are treated 3 weeks with appropriate antibiotics after antibiogram evaluation. Receives: 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. Receives: Drug: Reduction in the duration of antibiotic therapy 3 weeks or 6 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
Time needed for a complete wound healing in each group.
A wound healing is complete with epithelial wound closure maintained 28 days minimum of the initial site of injury caused by osteomyelitis.
Measured: 12 months
Rates of reinfection at the initial site in each group of patients.
Reinfection is defined by a relapse of infection of soft tissues and osteomyelitis.
Measured: 12 months
Rates of occurrence of a new wound after healing, on the same site initially traited in each group of patients.
A new wound is defined by a skin injury under the malleolus evolving over three weeks.
Measured: 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.
A new wound is defined by a skin injury under the malleolus evolving over three weeks.
Measured: 12 months
Rates of occurrence of a peripheral neuroathropathy (Charcot foot) in each group of patients.
Neurologic exam includes monofilament test and tuning fork test for assessing the loss of protective sensation.
Measured: 12 months
Rates of amputation in each group of patients.
Minor amputation is defined as an amputation below the ankle (malleolus). Major amputation is defined as an amputation above the ankle (malleolus).
Measured: 12 months
Rates of major amputation in each group of patients.
Major amputation is defined as an amputation above the ankle (malleolus).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start1 May 2022
- Primary completionNov 2024 (estimated)
- Study completionNov 2026 (estimated)
Why it stopped: logistical and financial problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteomyelitis - FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tourcoing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric M SENNEVILLE, MD, PhD, Principal investigator, Centre Hospitalier de Tourcoing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074147
- Sponsor's protocol ID
- RIPH_2019_04
- Acronym
- CHRONOS-2
- Status last verified
- Jan 2026
- First submitted
- 29 Sep 2021
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Weeks Versus Six Weeks Antibiotic Therapy for Nonsurgically Treated Diabetic Foot Osteomyelitis : a Multicenter, Randomized, Open-label and Controlled Study
- ClinicalTrials.gov ID
- NCT05074147
- Acronym / sponsor ID
- CHRONOS-2 / RIPH_2019_04
- Conditions
- Osteomyelitis - Foot
- Keywords
- Diabetes Mellitus, Antibiotic Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: logistical and financial problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tourcoing HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 weeks antibiotherapy | Experimental | Drug: Reduction in the duration of antibiotic therapy 3 weeks or 6 weeksPatients are treated 3 weeks with appropriate antibiotics after antibiogram evaluation. |
| 6 weeks antibiotherapy | Experimental | Drug: Reduction in the duration of antibiotic therapy 3 weeks or 6 weeksPatients are treated 6 weeks with appropriate antibiotics after antibiogram evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduction in the duration of antibiotic therapy 3 weeks or 6 weeksDrugs : * 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 | Drug | 3 weeks antibiotherapy, 6 weeks antibiotherapy |
Primary outcome
Percentage of treated patients achieving remission from the diabetic foot osteomyelitis at the end of follow-up
Time frame: 12 months
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.
7 secondary outcomes
Time needed for a complete wound healing in each group.
Time frame: 12 months
Rates of reinfection at the initial site in each group of patients.
Time frame: 12 months
Rates of occurrence of a new wound after healing, on the same site initially traited in each group of patients.
Time frame: 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.
Time frame: 12 months
Rates of occurrence of a peripheral neuroathropathy (Charcot foot) in each group of patients.
Time frame: 12 months
Rates of amputation in each group of patients.
Time frame: 12 months
Rates of major amputation in each group of patients.
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric M SENNEVILLE, MD, PhD principal investigator
Centre Hospitalier de Tourcoing
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Reduction in the duration of antibiotic therapy 3 weeks or 6 weeks in people with Osteomyelitis - Foot, run by Tourcoing Hospital at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of treated patients achieving remission from the diabetic foot osteomyelitis at the end of follow-up (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026; AzTrials last refreshed its copy on 2 Nov 2026.