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Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for Osteomyelitis (CRO-OSTEO)

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ClinicalTrials.gov Identifier: NCT02168816
Recruitment Status : Terminated (The study was stopped for feasibility (i.e., low recruitment))
First Posted : June 20, 2014
Results First Posted : June 8, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Pinzur, M.D., Loyola University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Osteomyelitis Drug: Intravenous Antibacterial Agent Drug: Oral Antibacterial Agent Phase 2

Detailed Description:

Currently, available literature is not adequate to determine the best agent, route, or duration of antibiotic therapy for the treatment of chronic osteomyelitis. The standard of therapy has been to treat patients with a parenteral antibiotic for four to six weeks. In a recent literature review by Spellberg et al. it was concluded that oral and parenteral antibiotic therapy have similar cure rates for the treatment of chronic osteomyelitis. Oral antibiotic therapy is associated with a lower risk to the patient due to avoiding the need of a central IV line. Additionally, oral therapy costs less than a course of IV antibiotics. Oral antibiotics with high bioavailability and good bone penetration include, fluoroquinolones, linezolid, trimethoprim/sulfamethoxazole (2 tabs bid), clindamycin and metronidazole. These antibiotics have been shown in recent studies to obtain levels in the bone that exceed the minimum inhibitory concentration (MIC) levels of the targeted organisms. According to the IDSA 2012 guidelines for the treatment of diabetic foot infections, the diagnosis of osteomyelitis can be made via plain radiographs or MRI imaging (more sensitive). A bone scan can be considered if an MRI cannot be done. The preferred method of diagnosis is by bone culture and histology. The guidelines also recommend surgical debridement to healthy tissue for diabetic foot infections followed by antibiotic therapy.

The Purpose of this study is to compare the efficacy of oral antibiotic therapy with intravenous antibiotic therapy for the treatment of diabetic foot osteomyelitis following surgical debridement. They hypothesis is that oral antibiotic therapy is equivalent to intravenous antibiotic therapy for the treatment of diabetic foot osteomyelitis.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for the Treatment of Diabetic Foot Osteomyelitis (CRO-OSTEOMYELITIS)
Actual Study Start Date : March 19, 2014
Actual Primary Completion Date : February 2, 2017
Actual Study Completion Date : February 2, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Midfoot
Individuals with an infection on the midfoot are randomized to an intravenous antibacterial agent or an oral antibacterial agent.
Drug: Intravenous Antibacterial Agent
Individuals in this arm receive an intravenous antibacterial agent. They are not assigned to specific medications. Individuals in this arm will receive an intravenous antibacterial agent as determined by their primary healthcare provider. This therapy is usually one of the following intravenous medications: (i) piperacillin/tazobactam (Zosyn), (ii) cefepime, (iii) metronidazole, (iv) aztreonam, (v) vancomycin, (vi) daptomycin, (vii) linezolid (Zyvox), and/or (viii) meropenem.
Other Names:
  • Piperacillin/tazobactam (Zosyn)
  • Cefepime
  • Metronidazole
  • Aztreonam
  • Vancomycin
  • Daptomycin
  • Linezolid (Zyvox)
  • Meropenem

Drug: Oral Antibacterial Agent
Individuals in this arm receive an oral antibacterial agent. They are not assigned to specific medications. Individuals in this arm will receive an oral antibacterial agent as determined by their primary healthcare provider. This therapy is usually one of the following oral medications: (i) sulfamethoxazole/trimethoprim (SMX-TMP), (ii) clindamycin (Clindesse), (iii) linezolid (Zyvox), (iv) moxifloxacin (Avelox), (v) ciprofloxacin (Cetraxal), and/or (vi) metronidazole (Flagyl)
Other Names:
  • Sulfamethoxazole/Trimethoprim (SMX-TMP)
  • Clindamycin (Clindesse)
  • Linezolid (Zyvox)
  • Moxifloxacin (Avelox)
  • Ciprofloxacin (Cetraxal)
  • Metronidazole (Flagyl)

Active Comparator: Hindfoot
Individuals with an infection on the hindfoot are randomized to an intravenous antibacterial agent or an oral antibacterial agent.
Drug: Intravenous Antibacterial Agent
Individuals in this arm receive an intravenous antibacterial agent. They are not assigned to specific medications. Individuals in this arm will receive an intravenous antibacterial agent as determined by their primary healthcare provider. This therapy is usually one of the following intravenous medications: (i) piperacillin/tazobactam (Zosyn), (ii) cefepime, (iii) metronidazole, (iv) aztreonam, (v) vancomycin, (vi) daptomycin, (vii) linezolid (Zyvox), and/or (viii) meropenem.
Other Names:
  • Piperacillin/tazobactam (Zosyn)
  • Cefepime
  • Metronidazole
  • Aztreonam
  • Vancomycin
  • Daptomycin
  • Linezolid (Zyvox)
  • Meropenem

Drug: Oral Antibacterial Agent
Individuals in this arm receive an oral antibacterial agent. They are not assigned to specific medications. Individuals in this arm will receive an oral antibacterial agent as determined by their primary healthcare provider. This therapy is usually one of the following oral medications: (i) sulfamethoxazole/trimethoprim (SMX-TMP), (ii) clindamycin (Clindesse), (iii) linezolid (Zyvox), (iv) moxifloxacin (Avelox), (v) ciprofloxacin (Cetraxal), and/or (vi) metronidazole (Flagyl)
Other Names:
  • Sulfamethoxazole/Trimethoprim (SMX-TMP)
  • Clindamycin (Clindesse)
  • Linezolid (Zyvox)
  • Moxifloxacin (Avelox)
  • Ciprofloxacin (Cetraxal)
  • Metronidazole (Flagyl)

Active Comparator: Toe
Individuals with an infection on the toe are randomized to an intravenous antibacterial agent or an oral antibacterial agent.
Drug: Intravenous Antibacterial Agent
Individuals in this arm receive an intravenous antibacterial agent. They are not assigned to specific medications. Individuals in this arm will receive an intravenous antibacterial agent as determined by their primary healthcare provider. This therapy is usually one of the following intravenous medications: (i) piperacillin/tazobactam (Zosyn), (ii) cefepime, (iii) metronidazole, (iv) aztreonam, (v) vancomycin, (vi) daptomycin, (vii) linezolid (Zyvox), and/or (viii) meropenem.
Other Names:
  • Piperacillin/tazobactam (Zosyn)
  • Cefepime
  • Metronidazole
  • Aztreonam
  • Vancomycin
  • Daptomycin
  • Linezolid (Zyvox)
  • Meropenem

Drug: Oral Antibacterial Agent
Individuals in this arm receive an oral antibacterial agent. They are not assigned to specific medications. Individuals in this arm will receive an oral antibacterial agent as determined by their primary healthcare provider. This therapy is usually one of the following oral medications: (i) sulfamethoxazole/trimethoprim (SMX-TMP), (ii) clindamycin (Clindesse), (iii) linezolid (Zyvox), (iv) moxifloxacin (Avelox), (v) ciprofloxacin (Cetraxal), and/or (vi) metronidazole (Flagyl)
Other Names:
  • Sulfamethoxazole/Trimethoprim (SMX-TMP)
  • Clindamycin (Clindesse)
  • Linezolid (Zyvox)
  • Moxifloxacin (Avelox)
  • Ciprofloxacin (Cetraxal)
  • Metronidazole (Flagyl)




Primary Outcome Measures :
  1. Number of Participants With Bone Infection [ Time Frame: Six Months ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Ulcer Resolution [ Time Frame: Six Months ]
    Six months following completion of treatment, the researchers record whether each participant's ulcer has resolved.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168816


Locations
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United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Investigators
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Principal Investigator: Michael Pinzur, M.D. Loyola University
  Study Documents (Full-Text)

Documents provided by Michael Pinzur, M.D., Loyola University:

Publications:

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Responsible Party: Michael Pinzur, M.D., Professor, Loyola University
ClinicalTrials.gov Identifier: NCT02168816     History of Changes
Other Study ID Numbers: 206209
First Posted: June 20, 2014    Key Record Dates
Results First Posted: June 8, 2018
Last Update Posted: July 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Michael Pinzur, M.D., Loyola University:
Osteomyelitis
Diabetes
Foot Infection

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Piperacillin, Tazobactam Drug Combination
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents
Norgestimate, ethinyl estradiol drug combination
Antitubercular Agents
Antineoplastic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Urinary
Renal Agents
Anti-Dyskinesia Agents
Osteomyelitis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Moxifloxacin
Metronidazole
Vancomycin
Ciprofloxacin
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Linezolid
Meropenem