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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteomyelitis
Interventions Drug: Intravenous Antibacterial Agent
Drug: Oral Antibacterial Agent
Enrollment 30
Recruitment Details Participants were recruited from March 2014 through February 2017 (36 months) from a tertiary care practice
Pre-assignment Details Prior to randomization, 16 participants were excluded because they tested positive for organisms that were resistant to oral antibiotic therapy. Additionally, one participant withdrew prior to randomization and one participant was excluded prior to randomization due to a definitive amputation.
Arm/Group Title Oral Antibacterial Agent Intravenous Antibacterial Agent
Hide Arm/Group Description Individuals in this arm were randomized to an oral antibacterial agent. They were not assigned to specific medications. Instead, individuals in this arm received an oral antibacterial agent as determined by their primary healthcare provider. This therapy was 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) Individuals in this arm were randomized to an intravenous antibacterial agent. They were not assigned to specific medications. Instead, individuals in this arm received an intravenous antibacterial agent as determined by their primary healthcare provider. This therapy was 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.
Period Title: Overall Study
Started 5 7
Completed 3 5
Not Completed 2 2
Reason Not Completed
Lost to Follow-up             2             2
Arm/Group Title Intravenous Antibacterial Agent Oral Antibacterial Agent Total
Hide Arm/Group Description Individuals in this arm were randomized to an intravenous antibacterial agent. They were not assigned to specific medications. Instead, individuals in this arm received an intravenous antibacterial agent as determined by their primary healthcare provider. This therapy was 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. Individuals in this arm were randomized to an oral antibacterial agent. They were not assigned to specific medications. Instead, individuals in this arm received an oral antibacterial agent as determined by their primary healthcare provider. This therapy was 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) Total of all reporting groups
Overall Number of Baseline Participants 7 5 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 7 participants 5 participants 12 participants
56.18
(36.28 to 70.59)
45.86
(37.99 to 62.00)
54.60
(37.14 to 65.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
7
 100.0%
5
 100.0%
12
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
Hispanic or Latino
2
  28.6%
1
  20.0%
3
  25.0%
Not Hispanic or Latino
5
  71.4%
4
  80.0%
9
  75.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  14.3%
2
  40.0%
3
  25.0%
White
4
  57.1%
3
  60.0%
7
  58.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
  28.6%
0
   0.0%
2
  16.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 5 participants 12 participants
7 5 12
Comorbid Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
No
0
   0.0%
0
   0.0%
0
   0.0%
Yes
7
 100.0%
5
 100.0%
12
 100.0%
Comorbid Peripheral Vascular Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
No
6
  85.7%
5
 100.0%
11
  91.7%
Yes
1
  14.3%
0
   0.0%
1
   8.3%
Comorbid Coronary Artery Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
No
6
  85.7%
4
  80.0%
10
  83.3%
Yes
1
  14.3%
1
  20.0%
2
  16.7%
Comorbid Chronic Kidney Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
No
7
 100.0%
4
  80.0%
11
  91.7%
Yes
0
   0.0%
1
  20.0%
1
   8.3%
Comorbid Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
No
2
  28.6%
2
  40.0%
4
  33.3%
Yes
5
  71.4%
3
  60.0%
8
  66.7%
Comorbid Heart Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
No
7
 100.0%
4
  80.0%
11
  91.7%
Yes
0
   0.0%
1
  20.0%
1
   8.3%
Comorbid Hyperlipidemia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
No
3
  42.9%
3
  60.0%
6
  50.0%
Yes
4
  57.1%
2
  40.0%
6
  50.0%
Comorbid Thyroid Disorder  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
No
7
 100.0%
5
 100.0%
12
 100.0%
Yes
0
   0.0%
0
   0.0%
0
   0.0%
Comorbid Depression  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
No
7
 100.0%
5
 100.0%
12
 100.0%
Yes
0
   0.0%
0
   0.0%
0
   0.0%
Comorbid Cancer  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
No
7
 100.0%
5
 100.0%
12
 100.0%
Yes
0
   0.0%
0
   0.0%
0
   0.0%
History of Stroke  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
No
7
 100.0%
5
 100.0%
12
 100.0%
Yes
0
   0.0%
0
   0.0%
0
   0.0%
History of Heart Attack  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
No
7
 100.0%
5
 100.0%
12
 100.0%
Yes
0
   0.0%
0
   0.0%
0
   0.0%
Comorbid Obesity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
No
6
  85.7%
5
 100.0%
11
  91.7%
Yes
1
  14.3%
0
   0.0%
1
   8.3%
1.Primary Outcome
Title Number of Participants With Bone Infection
Hide Description 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.
Time Frame Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprises all randomized participants who had a six month follow-up appointment.
Arm/Group Title Intravenous Antibacterial Agent Oral Antibacterial Agent
Hide Arm/Group Description:
Individuals in this arm were randomized to an intravenous antibacterial agent. They were not assigned to specific medications. Instead, individuals in this arm received an intravenous antibacterial agent as determined by their primary healthcare provider. This therapy was 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.
Individuals in this arm were randomized to an oral antibacterial agent. They were not assigned to specific medications. Instead, individuals in this arm received an oral antibacterial agent as determined by their primary healthcare provider. This therapy was 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)
Overall Number of Participants Analyzed 5 3
Measure Type: Count of Participants
Unit of Measure: Participants
Bone Infection Negative
5
 100.0%
3
 100.0%
Bone Infection Positive
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Number of Participants With Ulcer Resolution
Hide Description Six months following completion of treatment, the researchers record whether each participant's ulcer has resolved.
Time Frame Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprises all randomized participants who had a six month follow-up appointment.
Arm/Group Title Intravenous Antibacterial Agent Oral Antibacterial Agent
Hide Arm/Group Description:
Individuals in this arm were randomized to an intravenous antibacterial agent. They were not assigned to specific medications. Instead, individuals in this arm received an intravenous antibacterial agent as determined by their primary healthcare provider. This therapy was 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.
Individuals in this arm were randomized to an oral antibacterial agent. They were not assigned to specific medications. Instead, individuals in this arm received an oral antibacterial agent as determined by their primary healthcare provider. This therapy was 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)
Overall Number of Participants Analyzed 5 3
Measure Type: Count of Participants
Unit of Measure: Participants
Not Resolved
5
 100.0%
2
  66.7%
Resolved
0
   0.0%
1
  33.3%
Time Frame Adverse event data were collected from March 2014 through February 2017 (36 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intravenous Antibacterial Agent Oral Antibacterial Agent
Hide Arm/Group Description Individuals in this arm were randomized to an intravenous antibacterial agent. They were not assigned to specific medications. Instead, individuals in this arm received an intravenous antibacterial agent as determined by their primary healthcare provider. This therapy was 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. Individuals in this arm were randomized to an oral antibacterial agent. They were not assigned to specific medications. Instead, individuals in this arm received an oral antibacterial agent as determined by their primary healthcare provider. This therapy was 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)
All-Cause Mortality
Intravenous Antibacterial Agent Oral Antibacterial Agent
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)      0/5 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Intravenous Antibacterial Agent Oral Antibacterial Agent
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intravenous Antibacterial Agent Oral Antibacterial Agent
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      1/5 (20.00%)    
Blood and lymphatic system disorders     
Hyperkalemia *  0/7 (0.00%)  0 1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
The trial was stopped prematurely for feasibility (i.e., low recruitment)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Michael Pinzur, M.D.
Organization: Loyola University Medical Center
Phone: 708-216-4993
Publications:
Responsible Party: Michael Pinzur, M.D., Loyola University
ClinicalTrials.gov Identifier: NCT02168816     History of Changes
Other Study ID Numbers: 206209
First Submitted: June 10, 2014
First Posted: June 20, 2014
Results First Submitted: May 8, 2018
Results First Posted: June 8, 2018
Last Update Posted: July 19, 2018