Trial Outcomes & Findings for Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for Osteomyelitis (NCT NCT02168816)
NCT ID: NCT02168816
Last Updated: 2018-07-19
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Six Months
Results posted on
2018-07-19
Participant Flow
Participants were recruited from March 2014 through February 2017 (36 months) from a tertiary care practice
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.
Participant milestones
| Measure |
Oral Antibacterial Agent
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)
|
Intravenous Antibacterial Agent
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.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Oral Antibacterial Agent
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)
|
Intravenous Antibacterial Agent
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for Osteomyelitis
Baseline characteristics by cohort
| Measure |
Intravenous Antibacterial Agent
n=7 Participants
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.
|
Oral Antibacterial Agent
n=5 Participants
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
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.18 years
n=5 Participants
|
45.86 years
n=7 Participants
|
54.60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Comorbid Diabetes
No
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Comorbid Diabetes
Yes
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Comorbid Peripheral Vascular Disease
No
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Comorbid Peripheral Vascular Disease
Yes
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Comorbid Coronary Artery Disease
No
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Comorbid Coronary Artery Disease
Yes
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Comorbid Chronic Kidney Disease
No
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Comorbid Chronic Kidney Disease
Yes
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Comorbid Hypertension
No
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Comorbid Hypertension
Yes
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Comorbid Heart Disease
No
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Comorbid Heart Disease
Yes
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Comorbid Hyperlipidemia
No
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Comorbid Hyperlipidemia
Yes
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Comorbid Thyroid Disorder
No
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Comorbid Thyroid Disorder
Yes
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Comorbid Depression
No
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Comorbid Depression
Yes
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Comorbid Cancer
No
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Comorbid Cancer
Yes
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
History of Stroke
No
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
History of Stroke
Yes
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
History of Heart Attack
No
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
History of Heart Attack
Yes
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Comorbid Obesity
No
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Comorbid Obesity
Yes
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Six MonthsPopulation: The analysis population comprises all randomized participants who had a six month follow-up appointment.
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.
Outcome measures
| Measure |
Intravenous Antibacterial Agent
n=5 Participants
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.
|
Oral Antibacterial Agent
n=3 Participants
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)
|
|---|---|---|
|
Number of Participants With Bone Infection
Bone Infection Negative
|
5 Participants
|
3 Participants
|
|
Number of Participants With Bone Infection
Bone Infection Positive
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Six MonthsPopulation: The analysis population comprises all randomized participants who had a six month follow-up appointment.
Six months following completion of treatment, the researchers record whether each participant's ulcer has resolved.
Outcome measures
| Measure |
Intravenous Antibacterial Agent
n=5 Participants
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.
|
Oral Antibacterial Agent
n=3 Participants
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)
|
|---|---|---|
|
Number of Participants With Ulcer Resolution
Resolved
|
0 Participants
|
1 Participants
|
|
Number of Participants With Ulcer Resolution
Not Resolved
|
5 Participants
|
2 Participants
|
Adverse Events
Intravenous Antibacterial Agent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oral Antibacterial Agent
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intravenous Antibacterial Agent
n=7 participants at risk
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.
|
Oral Antibacterial Agent
n=5 participants at risk
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)
|
|---|---|---|
|
Blood and lymphatic system disorders
Hyperkalemia
|
0.00%
0/7 • Adverse event data were collected from March 2014 through February 2017 (36 months)
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected from March 2014 through February 2017 (36 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place