Trial Outcomes & Findings for Comparing Oral Versus Parenteral Antimicrobial Therapy (NCT NCT05977868)
NCT ID: NCT05977868
Last Updated: 2025-08-26
Results Overview
Number of patients with cure/control using clinical (resolution of infection - e.g., wound healed) and laboratory (improvement in inflammatory markers - e.g., CRP normalization) parameters as adjudicated by 2 ID faculty blinded to study arm
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
94 participants
Primary outcome timeframe
3 months after hospital discharge
Results posted on
2025-08-26
Participant Flow
Participant milestones
| Measure |
Group 1 (Experimental)
COpAT (oral antimicrobial therapy) on hospital discharge
Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid: COpAT (oral antimicrobial therapy) on hospital discharge
|
Group 2 (Control)
Standard of care (IV antimicrobial therapy) on hospital discharge
Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem: Standard of care (IV antimicrobial therapy) on hospital discharge
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
30
|
|
Overall Study
COMPLETED
|
62
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Group 1 (Experimental)
COpAT (oral antimicrobial therapy) on hospital discharge
Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid: COpAT (oral antimicrobial therapy) on hospital discharge
|
Group 2 (Control)
Standard of care (IV antimicrobial therapy) on hospital discharge
Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem: Standard of care (IV antimicrobial therapy) on hospital discharge
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Transitioned to comfort care
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1 (Experimental)
n=62 Participants
COpAT (oral antimicrobial therapy) on hospital discharge
Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid: COpAT (oral antimicrobial therapy) on hospital discharge
|
Group 2 (Control)
n=28 Participants
Standard of care (IV antimicrobial therapy) on hospital discharge
Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem: Standard of care (IV antimicrobial therapy) on hospital discharge
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
n=62 Participants
|
61.5 years
n=28 Participants
|
60 years
n=90 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=62 Participants
|
8 Participants
n=28 Participants
|
33 Participants
n=90 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=62 Participants
|
20 Participants
n=28 Participants
|
57 Participants
n=90 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
62 participants
n=62 Participants
|
28 participants
n=28 Participants
|
90 participants
n=90 Participants
|
|
Length of Hospital Stay
|
8 days
n=62 Participants
|
10 days
n=28 Participants
|
9 days
n=90 Participants
|
|
Comorbidities
Obesity
|
39 participants
n=62 Participants
|
17 participants
n=28 Participants
|
56 participants
n=90 Participants
|
|
Comorbidities
Diabetes
|
33 participants
n=62 Participants
|
11 participants
n=28 Participants
|
44 participants
n=90 Participants
|
|
Comorbidities
Cardiac
|
18 participants
n=62 Participants
|
13 participants
n=28 Participants
|
31 participants
n=90 Participants
|
|
Comorbidities
Pulmonary
|
10 participants
n=62 Participants
|
5 participants
n=28 Participants
|
15 participants
n=90 Participants
|
|
Comorbidities
Renal
|
6 participants
n=62 Participants
|
0 participants
n=28 Participants
|
6 participants
n=90 Participants
|
|
Infection Type
Endovascular
|
8 Participants
n=62 Participants
|
5 Participants
n=28 Participants
|
13 Participants
n=90 Participants
|
|
Infection Type
Bone and Joint
|
46 Participants
n=62 Participants
|
20 Participants
n=28 Participants
|
66 Participants
n=90 Participants
|
|
Infection Type
Other
|
8 Participants
n=62 Participants
|
3 Participants
n=28 Participants
|
11 Participants
n=90 Participants
|
|
Bacteremia
|
30 Participants
n=62 Participants
|
13 Participants
n=28 Participants
|
43 Participants
n=90 Participants
|
|
Surgery/Drainage
|
55 Participants
n=62 Participants
|
19 Participants
n=28 Participants
|
74 Participants
n=90 Participants
|
|
Organism Isolated
Staphylococcus aureus
|
38 participants
n=62 Participants
|
17 participants
n=28 Participants
|
55 participants
n=90 Participants
|
|
Organism Isolated
MRSA
|
15 participants
n=62 Participants
|
3 participants
n=28 Participants
|
18 participants
n=90 Participants
|
|
Organism Isolated
MSSA
|
23 participants
n=62 Participants
|
14 participants
n=28 Participants
|
37 participants
n=90 Participants
|
|
Organism Isolated
Streptococcus species
|
13 participants
n=62 Participants
|
7 participants
n=28 Participants
|
20 participants
n=90 Participants
|
|
Organism Isolated
Enterobacterales
|
8 participants
n=62 Participants
|
3 participants
n=28 Participants
|
11 participants
n=90 Participants
|
PRIMARY outcome
Timeframe: 3 months after hospital dischargeNumber of patients with cure/control using clinical (resolution of infection - e.g., wound healed) and laboratory (improvement in inflammatory markers - e.g., CRP normalization) parameters as adjudicated by 2 ID faculty blinded to study arm
Outcome measures
| Measure |
Group 1 (Experimental)
n=62 Participants
COpAT (oral antimicrobial therapy) on hospital discharge
Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid: COpAT (oral antimicrobial therapy) on hospital discharge
|
Group 2 (Control)
n=28 Participants
Standard of care (IV antimicrobial therapy) on hospital discharge
Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem: Standard of care (IV antimicrobial therapy) on hospital discharge
|
|---|---|---|
|
Cure/Control at 3 Months
|
61 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: Up to 3 months after hospital dischargeNumber of participants with adverse events requiring intervention related to antimicrobial therapy (e.g., thrombocytopenia)
Outcome measures
| Measure |
Group 1 (Experimental)
n=62 Participants
COpAT (oral antimicrobial therapy) on hospital discharge
Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid: COpAT (oral antimicrobial therapy) on hospital discharge
|
Group 2 (Control)
n=28 Participants
Standard of care (IV antimicrobial therapy) on hospital discharge
Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem: Standard of care (IV antimicrobial therapy) on hospital discharge
|
|---|---|---|
|
Adverse Events Related to Antimicrobial Therapy
|
4 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 3 months after hospital dischargeNumber of participants with adverse events requiring intervention related to vascular access complication (e.g., deep venous thrombosis)
Outcome measures
| Measure |
Group 1 (Experimental)
n=62 Participants
COpAT (oral antimicrobial therapy) on hospital discharge
Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid: COpAT (oral antimicrobial therapy) on hospital discharge
|
Group 2 (Control)
n=28 Participants
Standard of care (IV antimicrobial therapy) on hospital discharge
Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem: Standard of care (IV antimicrobial therapy) on hospital discharge
|
|---|---|---|
|
Adverse Events Related to Vascular Access
|
0 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Up to 3 months after hospital dischargeNumber of participants readmitted for any reason up to 3 months after discharge from the hospital
Outcome measures
| Measure |
Group 1 (Experimental)
n=62 Participants
COpAT (oral antimicrobial therapy) on hospital discharge
Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid: COpAT (oral antimicrobial therapy) on hospital discharge
|
Group 2 (Control)
n=28 Participants
Standard of care (IV antimicrobial therapy) on hospital discharge
Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem: Standard of care (IV antimicrobial therapy) on hospital discharge
|
|---|---|---|
|
Overall Readmission
|
17 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 weeks after hospital dischargePopulation: Four withdrew early prior to hospital discharge: 3 chose not to participate, and one transitioned to comfort care (mortality).
Patient satisfaction using the COPAT Trial Patient Satisfaction Survey at 6 Weeks, which is a short questionnaire (with the overall satisfaction question incorporating a Likert scale 1= Very Dissatisfied, 5= Very Satisfied) designed to assess overall patient satisfaction. Overall satisfaction totaled from participants answering 4= Satisfied and 5= Very Satisfied.
Outcome measures
| Measure |
Group 1 (Experimental)
n=61 Participants
COpAT (oral antimicrobial therapy) on hospital discharge
Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid: COpAT (oral antimicrobial therapy) on hospital discharge
|
Group 2 (Control)
n=28 Participants
Standard of care (IV antimicrobial therapy) on hospital discharge
Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem: Standard of care (IV antimicrobial therapy) on hospital discharge
|
|---|---|---|
|
Number of Participants Reporting 'Satisfied' or 'Very Satisfied' on Patient Satisfaction Survey
|
60 participants
|
27 participants
|
SECONDARY outcome
Timeframe: 6 weeks after hospital dischargePopulation: Four withdrew early prior to hospital discharge: three chose not to participate, and one transitioned to comfort care (mortality).
The number of participants who expressed a preference to be in the other study arm (i.e., answers 'Yes' to the survey question "Would you have preferred to be in the other study arm? Yes or No").
Outcome measures
| Measure |
Group 1 (Experimental)
n=61 Participants
COpAT (oral antimicrobial therapy) on hospital discharge
Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid: COpAT (oral antimicrobial therapy) on hospital discharge
|
Group 2 (Control)
n=28 Participants
Standard of care (IV antimicrobial therapy) on hospital discharge
Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem: Standard of care (IV antimicrobial therapy) on hospital discharge
|
|---|---|---|
|
Number of Participants Who Answered 'Yes' to the Survey Question "Would You Have Preferred to be in the Other Study Arm? (Yes or No)"
|
1 participants
|
21 participants
|
Adverse Events
Experimental
Serious events: 18 serious events
Other events: 4 other events
Deaths: 1 deaths
Control
Serious events: 7 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental
n=64 participants at risk
Discharged with oral antibiotics
|
Control
n=30 participants at risk
Discharged with IV antibiotics
|
|---|---|---|
|
General disorders
Readmission
|
10.9%
7/64 • Number of events 7 • Until study completion, for a duration of up to three months after hospital discharge
|
6.7%
2/30 • Number of events 2 • Until study completion, for a duration of up to three months after hospital discharge
|
|
Surgical and medical procedures
Readmission
|
9.4%
6/64 • Number of events 7 • Until study completion, for a duration of up to three months after hospital discharge
|
3.3%
1/30 • Number of events 1 • Until study completion, for a duration of up to three months after hospital discharge
|
|
Infections and infestations
Readmission
|
4.7%
3/64 • Number of events 3 • Until study completion, for a duration of up to three months after hospital discharge
|
3.3%
1/30 • Number of events 1 • Until study completion, for a duration of up to three months after hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Readmission
|
3.1%
2/64 • Number of events 2 • Until study completion, for a duration of up to three months after hospital discharge
|
3.3%
1/30 • Number of events 2 • Until study completion, for a duration of up to three months after hospital discharge
|
|
Cardiac disorders
Readmission
|
1.6%
1/64 • Number of events 1 • Until study completion, for a duration of up to three months after hospital discharge
|
6.7%
2/30 • Number of events 3 • Until study completion, for a duration of up to three months after hospital discharge
|
|
Vascular disorders
Readmission
|
0.00%
0/64 • Until study completion, for a duration of up to three months after hospital discharge
|
3.3%
1/30 • Number of events 1 • Until study completion, for a duration of up to three months after hospital discharge
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mortality
|
1.6%
1/64 • Number of events 1 • Until study completion, for a duration of up to three months after hospital discharge
|
0.00%
0/30 • Until study completion, for a duration of up to three months after hospital discharge
|
Other adverse events
| Measure |
Experimental
n=64 participants at risk
Discharged with oral antibiotics
|
Control
n=30 participants at risk
Discharged with IV antibiotics
|
|---|---|---|
|
General disorders
Antibiotic Side Effect
|
4.7%
3/64 • Number of events 3 • Until study completion, for a duration of up to three months after hospital discharge
|
6.7%
2/30 • Number of events 2 • Until study completion, for a duration of up to three months after hospital discharge
|
|
Infections and infestations
Antibiotic Side Effect
|
1.6%
1/64 • Number of events 1 • Until study completion, for a duration of up to three months after hospital discharge
|
3.3%
1/30 • Number of events 1 • Until study completion, for a duration of up to three months after hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Antibiotic Side Effect
|
0.00%
0/64 • Until study completion, for a duration of up to three months after hospital discharge
|
3.3%
1/30 • Number of events 1 • Until study completion, for a duration of up to three months after hospital discharge
|
|
Vascular disorders
Line Related Adverse Event
|
0.00%
0/64 • Until study completion, for a duration of up to three months after hospital discharge
|
23.3%
7/30 • Number of events 8 • Until study completion, for a duration of up to three months after hospital discharge
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place