Osteomyelitis Clinical Trial
— CRO-OSTEOOfficial title:
Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for the Treatment of Diabetic Foot Osteomyelitis (CRO-OSTEOMYELITIS)
Verified date | June 2018 |
Source | Loyola University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Infectious Diseases Society of America (IDSA) 2012 guidelines for the diagnosis and
treatment of diabetic foot infections state that for the treatment of diabetic foot
osteomyelitis "No data support the superiority of any specific antibiotic agent or treatment
strategy, route, or duration of therapy." Traditionally, osteomyelitis has been treated with
a long course of intravenous antibiotics, generally six weeks. Oral antibiotics with high
bioavailability and adequate bone penetration have been shown in published studies to be
effective for the treatment of osteomyelitis.
The investigators propose to conduct a prospective, single-center, randomized, open trial at
Loyola University Medical Center (LUMC) comparing the efficacy of oral antibiotic therapy to
intravenous (IV) antibiotic therapy for the treatment of diabetic foot osteomyelitis. The
investigators hypothesize that oral antibiotic therapy is equivalent to IV antibiotic
therapy. Bone/tissue cultures are obtained for all patients for clinical purposes and are
sent to pathology for histologic examination and to the clinical microbiology laboratory for
culture and susceptibility. Patients will receive six weeks of IV or oral antibiotic therapy
depending upon their randomization group. Primary outcomes at six months clinical follow-up
will include: (i) no evidence of bone infection and (ii) resolution of ulcer.
Status | Terminated |
Enrollment | 30 |
Est. completion date | February 2, 2017 |
Est. primary completion date | February 2, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years of age and older - Diagnosis of Diabetes Mellitus (per past medical history documented in the patient medical record) - Foot osteomyelitis (distal to ankle) - Surgical debridement (in operating room) Exclusion Criteria: - Absolute neutrophil count (ANC) < 500 - Pregnant or lactating patients - Patients with organisms resistant to oral therapy - Internal hardware - Definitive amputations (BKA) - Limb ischemia [absent pedal pulses or ankle-brachial index (ABI) < 0.5] |
Country | Name | City | State |
---|---|---|---|
United States | Loyola University Medical Center | Maywood | Illinois |
Lead Sponsor | Collaborator |
---|---|
Loyola University |
United States,
Bouazza N, Pestre V, Jullien V, Curis E, Urien S, Salmon D, Tréluyer JM. Population pharmacokinetics of clindamycin orally and intravenously administered in patients with osteomyelitis. Br J Clin Pharmacol. 2012 Dec;74(6):971-7. doi: 10.1111/j.1365-2125.2012.04292.x. — View Citation
Lazzarini L, Lipsky BA, Mader JT. Antibiotic treatment of osteomyelitis: what have we learned from 30 years of clinical trials? Int J Infect Dis. 2005 May;9(3):127-38. Review. — View Citation
Lipsky BA, Berendt AR, Cornia PB, Pile JC, Peters EJ, Armstrong DG, Deery HG, Embil JM, Joseph WS, Karchmer AW, Pinzur MS, Senneville E; Infectious Diseases Society of America. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012 Jun;54(12):e132-73. doi: 10.1093/cid/cis346. — View Citation
Pinzur MS, Gil J, Belmares J. Treatment of osteomyelitis in charcot foot with single-stage resection of infection, correction of deformity, and maintenance with ring fixation. Foot Ankle Int. 2012 Dec;33(12):1069-74. doi: DOI: 10.3113/FAI.2012.1069. — View Citation
Spellberg B, Lipsky BA. Systemic antibiotic therapy for chronic osteomyelitis in adults. Clin Infect Dis. 2012 Feb 1;54(3):393-407. doi: 10.1093/cid/cir842. Epub 2011 Dec 12. Review. — View Citation
Wukich DK, Armstrong DG, Attinger CE, Boulton AJ, Burns PR, Frykberg RG, Hellman R, Kim PJ, Lipsky BA, Pile JC, Pinzur MS, Siminerio L. Inpatient management of diabetic foot disorders: a clinical guide. Diabetes Care. 2013 Sep;36(9):2862-71. doi: 10.2337/dc12-2712. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Bone Infection | Six months following completion of treatment, the researchers record evidence of bone infection for each participant. A negative diagnosis is made when there is (i) an absence of infection based on clinical examination and (ii) down-trending of inflammatory markers. Otherwise, a positive diagnosis is made. | Six Months | |
Secondary | Number of Participants With Ulcer Resolution | Six months following completion of treatment, the researchers record whether each participant's ulcer has resolved. | Six Months |
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