CSP #2001 - Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics (VA Intrepid)
The purpose of this research study is to determine if rifampin, an antibiotic (a medicine that treats infections), is effective in treating osteomyelitis (infection of the bone) of the foot in diabetic patients. Despite use of powerful antibiotics prescribed over a long period of time, many diabetic patients remain at a high risk for needing an amputation of part of the foot or lower leg because the osteomyelitis is not cured. Some small research studies have shown that addition of rifampin to other antibiotics is effective in treating osteomyelitis in both diabetics and non-diabetics. However, because few diabetics with osteomyelitis have been studied, there is no definite proof that it is better than the usual treatments for diabetic patients. If this study finds that adding rifampin to the usual antibiotics prescribed for osteomyelitis reduces the risk for amputations, doctors will be able to more effectively treat many Veteran patients with this serious infection. Improving treatment outcomes is an important healthcare goal of the VA.
NCT03012529 — Diabetes
Status: Recruiting
http://inclinicaltrials.com/diabetes/NCT03012529/
Pressure Ulcer-associated Osteomyelitis: Retrospective Evaluation of a Two-stage Surgical Strategy (Debridement With Vacuum-assisted Closure Therapy and Reconstruction) With Prolonged Antimicrobial Therapy
Pressure ulcer represents a frequent clinical condition in patient with spinal cord injury or after prolonged Intensive Care Unit (ICU) stay. Osteomyelitis constitutes a severe complication with a poorly known management, and is associated with a high rate of relapse, leading to a high-burden in hospital bed-days, financial cost, surgical intervention, antibiotic use, morbidity and mortality, and nursing care. In our reference center for bone and joint infection management, the medical and surgical strategies are systematically discussed during pluridisciplinary meetings. Most patients benefit from a two-stage surgical strategy (debridement with initiation of vacuum-assisted closure therapy until reconstruction using muscular flap) with prolonged antimicrobial therapy. In this context, our study aims to evaluate this complex approach and to determine risk factors of treatment failure in order to improve patient management, focusing on optimization of empirical antimicrobial therapy after each surgical stage, delay between the two surgical stage, and duration of antimicrobial therapy.
NCT03010293 — Bone Diseases, Infectious
Status: Completed
http://inclinicaltrials.com/bone-diseases-infectious/NCT03010293/
Fifty-one patients suffering from chronic post-traumatic or postoperative osteomyelitis of the lower extremities were included in the retrospective investigation. The patients were assigned to the study group of the combination therapy with antibiotic-loaded calcium sulfate and antibiotic-loaded PMMA or the control group of the antibiotic-loaded PMMA. Hematological parameters, eradication of infection, rate of infection recurrence and reoperation rate were evaluated during the follow-up.
NCT02968693 — Osteomyelitis
Status: Completed
http://inclinicaltrials.com/osteomyelitis/NCT02968693/
Assessment of White Blood Cell SPECT/CT in Monitoring Antibiotic Treatment in Patients With Diabetic Foot Osteomyelitis
Osteomyelitis is a risk factor for lower extremity amputation in diabetic people. Antibiotic therapy allows a remission in 60 to 80% of cases. However the optimal duration of antibiotic therapy remains controversy due to the absence of validated marker of osteomyelitis remission. We have previously shown that the negativity of white blood cell SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography) imaging at the end of treatment allowed to predict remission of osteomyelitis at 1 year in all cases. A positive imaging was associated with recurrence in 70% of cases. The aim of our study was to evaluate prospectively the interest of white blood cell SPECT/CT to set the duration of antibiotic therapy.
NCT02927678 — Diabetic Foot Osteomyelitis
Status: Recruiting
http://inclinicaltrials.com/diabetic-foot-osteomyelitis/NCT02927678/
A Phase 2, Single-center, Open-label, Randomized, Comparator-controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis Known or Suspected to be Due to Gram-Positive Organisms
This clinical study will be a single-center, randomized, open-label, active-controlled, parallel-group study comparing dalbavancin to standard of care (SOC) therapy in osteomyelitis.
NCT02685033 — Osteomyelitis
Status: Completed
http://inclinicaltrials.com/osteomyelitis/NCT02685033/
Biofilm Formation Increases Treatment Failure in Staphylococcus Epidermidis Device-related Osteomyelitis in Human Patients
This was a prospective study performed between November 2011 and September 2013. Patients with a confirmed S. epidermidis infection after fracture fixation or prosthetic joint infection were included. Exclusion criteria included infections involving external fixation pins, infections without any implanted hardware and culture positive patients not displaying any clinical sign of infection. The following surgical parameters were documented: affected bone or joint; type of implant; time between implantation of the device and onset of symptoms. Personal characteristics and patients`health status were also documented. Any revision surgeries involving the site of interest and all isolated pathogens were recorded throughout the course of treatment and follow-up. A follow up examination was performed an average of 26 months after discharge. Primary outcome at follow up was cure. Cure was define by the authors as: missing local (at site of interest) or systemic signs of infection, terminated surgical and systemic therapy and restoration of joint or limb function. At the first surgical procedure after enrolment, at least four deep bone biopsies were taken from the interface between implant and affected bone. Identification and antibiotic susceptibility testing of all growth was performed. Multi-drug-resistance (MDR) was defined according to the definitions of the European Committee of Antimicrobial Susceptibility Testing (EUCAST). Biofilm formation was analysed and quantified in microtitre plate assays according to protocol of Stepanovic et al.(see references).
NCT02640937 — Staphylococcal Infections
Status: Completed
http://inclinicaltrials.com/staphylococcal-infections/NCT02640937/
Chronic Non-bacterial Osteomyelitis Treated With Pamidronate in a Randomised Placebo Controlled Trial
In a randomized double blind placebo controlled trial to investigate the effect of pamidronate in treatment of chronic non bacterial osteomyelitis. Main objective: 1. Reduction of the inflammatory activity in the bone lesions measured by whole body MRI after 36 weeks. 2. Healing of the inflammatory activity in the bone lesions measured by whole body MRI after 36 weeks. Secondary objectives: 1. Changes in bone lesions in whole body MRI between baseline and week 12 and between week 12 and week 36 2. Changes in bone lesions of anterior chest-wall (adults) evaluated by CT scan between baseline and week 36. 3. Changes in patient self reported outcome measures 4. Changes in inflammatory markers and bone markers.
NCT02594878 — Musculoskeletal Disease
Status: Recruiting
http://inclinicaltrials.com/musculoskeletal-disease/NCT02594878/
UT Southwestern Diabetic Foot Ulcers (DFU) and Osteomyelitis (DFO) Recruitment Database, Data and Tissue Repository
This will be a continuing, prospective study of diabetic foot ulcers and infections, risk factors and clinical outcomes and a limited data set conducted by the investigator through the establishment of a data and tissue repository in the uT Southwestern Department of Plastic Surgery. in addition, subjects consented for this research will be asked about inclusion in a recruitment database to be used in the recruitment of subjects for future research on diabetic foot complications. about 250 patients are seen for diabetic foot ulcers and infections each year.
NCT02463500 — Diabetic Foot Ulcers
Status: Completed
http://inclinicaltrials.com/diabetic-foot-ulcers/NCT02463500/
A Phase 3, Multicenter, Double-Blind, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis of the Long Bones Known or Suspected to be Due to Gram-Positive Organisms
Dalbavancin for Pediatric Osteomyelitis
NCT02344511 — Osteomyelitis
Status: Withdrawn
http://inclinicaltrials.com/osteomyelitis/NCT02344511/
Phase 1/2 Trial of Ceftaroline for the Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children
This research study is looking at an antibiotic medicine, Ceftaroline Fosamil (Ceftaroline), which fights infections like the one the subject has. Ceftaroline is effective against S.aureus germs including those that are called Methicillin Resistant Staphylococcus aureus (MRSA.) Ceftaroline has been approved by the U.S. Food and Drug Administration (FDA) for use in adults and children with Community-Acquired Bacterial Pneumonia [a type of lung infection] and Acute Bacterial Skin and Skin Structure Infections. Ceftaroline is not yet approved for treatment in subjects with hematogenous osteomyelitis, therefore, the use of Ceftaroline in this research study is considered "investigational". The goal of this research study is to find out what side effects there may be when children are taking Ceftaroline and to study how effective Ceftaroline is in treating bone infections due to Staphylococcus aureus in children. The investigators are also studying what the body does to the study drug, Ceftaroline, and if the doses the investigators use result in blood levels that the investigators think are going to be effective against bone infections in children. This is called pharmacokinetics (PK).
NCT02335905 — Osteomyelitis
Status: Completed
http://inclinicaltrials.com/osteomyelitis/NCT02335905/