Antibiotic Treatment Duration for Non-Surgically-Treated Diabetic Foot Osteomyelitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to compare the efficacy and tolerance of 6- versus 12-week antibiotic therapy in patients with diabetic foot osteomyelitis treated medically.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05074147

Osteomyelitis - Foot

WITHDRAWN PHASE3

Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections

NCT02378493

Diabetic Foot Staphylococcus Aureus

COMPLETED NA

Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for Osteomyelitis

NCT02168816

Osteomyelitis

TERMINATED PHASE2

Diabetic Foot Infection Antibiotic Study

NCT01539811

Diabetic Foot Infections

TERMINATED NA

Pathogenicity Factors of Staphylococcus Pettenkoferi in Foot Wounds and Osteitis in Diabetic Patients

NCT06688084

Diabetic Foot Ulcer

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The aim of this randomized multicenter clinical study is to compare the efficacy and tolerance of 6 versus 12-week antibiotic treatment in patients with diabetic foot osteomyelitis treated medically as no equivalent data are currenty available in the literature.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

antibiotic therapy

patients are treated with a 6 week-duration of antibiotic therapy :

* Rifampin IP and PO twice daily, 10mg/kg /12H
* Levofloxacin IV and PO 500-750mg once daily
* Doxycycline PO 200mg once daily
* Trimethoprim- sulfamethoxazole IV and PO 800/160mg thrice daily
* Fusidic acid PO 500mg twice daily
* Linezolid IV and PO 600mg twice daily
* Ciprofloxacin IV and PO 750to 1000mg/12h
* Cefotaxime IV 100mg/kg in three IV infusions daily
* Ceftriaxone IV,intramuscularly or subcutaneously 2g once daily
* Cefepime IV ou intra-muscularly 2g /8-12h

Group Type ACTIVE_COMPARATOR

duration of the antibiotic therapy

Intervention Type DRUG

12 week-duration of antibiotic therapy

patients are treated with a 12 week-duration of antibiotic therapy :

* Rifampin IP and PO twice daily, 10mg/kg /12H
* Levofloxacin IV and PO 500-750mg once daily
* Doxycycline PO 200mg once daily
* Trimethoprim- sulfamethoxazole IV and PO 800/160mg thrice daily
* Fusidic acid PO 500mg twice daily
* Linezolid IV and PO 600mg twice daily
* Ciprofloxacin IV and PO 750to 1000mg/12h
* Cefotaxime IV 100mg/kg in three IV infusions daily
* Ceftriaxone IV,intramuscularly or subcutaneously 2g once daily
* Cefepime IV ou intra-muscularly 2g /8-12h

Group Type ACTIVE_COMPARATOR

duration of the antibiotic therapy

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

duration of the antibiotic therapy

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

- Rifampin - Levofloxacin - Doxycycline - Trimethoprim- sulfamethoxazole - Fusidic acid - Linezolid - Ciprofloxacin - Cefotaxime - Ceftriaxone - Cefepime

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* diabetic patients treated non-surgically (i.e. without amputation or resection of the infected bone) for an osteomyelitis of the foot complicating a neuropathic foot without ischemia of the foot defined as the absence of any pedal pulse. Patients aged of 18 years or more were included if they had type 2 diabetes and osteomyelitis of the foot (i.e.below the ankle).