Trial Outcomes & Findings for Role of Intravenous Versus Home Oral Antibiotics in Perforated Appendicitis (NCT NCT02724410)
NCT ID: NCT02724410
Last Updated: 2022-05-17
Results Overview
Number of Postoperative Abscess, thirty-day postoperative
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
Thirty days after appendectomy
Results posted on
2022-05-17
Participant Flow
Participant milestones
| Measure |
Home Intravenous Ertapenem and PICC
Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class: carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages \<13; age 13 or greater, then 1 gm daily)
Peripheral inserted central Catheter: All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics.
|
Home Oral Amoxicillin-clavulanate
Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate (Drug Class: beta lactam antibiotic) (15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours).
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
38
|
|
Overall Study
COMPLETED
|
44
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Role of Intravenous Versus Home Oral Antibiotics in Perforated Appendicitis
Baseline characteristics by cohort
| Measure |
Home Intravenous Ertapenem and PICC
n=44 Participants
Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class: carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages \<13; age 13 or greater, then 1 gm daily)
Peripheral inserted central Catheter: All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics.
|
Home Oral Amoxicillin-clavulanate
n=38 Participants
Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate (Drug Class: beta lactam antibiotic) (15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours).
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.3 Years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
10.1 Years
STANDARD_DEVIATION 3.6 • n=7 Participants
|
11.3 Years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 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
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
43 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
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
BMI
|
20.9 kg/m^2
STANDARD_DEVIATION 5.8 • n=5 Participants
|
17.9 kg/m^2
STANDARD_DEVIATION 3.5 • n=7 Participants
|
19.5 kg/m^2
STANDARD_DEVIATION 5.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Thirty days after appendectomyNumber of Postoperative Abscess, thirty-day postoperative
Outcome measures
| Measure |
Home Intravenous Ertapenem and PICC
n=44 Participants
Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class: carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages \<13; age 13 or greater, then 1 gm daily)
Peripheral inserted central Catheter: All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics.
|
Home Oral Amoxicillin-clavulanate
n=38 Participants
Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate (Drug Class: beta lactam antibiotic) (15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours).
|
|---|---|---|
|
Number of Participants With Postoperative Abscess
|
5 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Thirty days following appendectomyNumber of Wound Infections, 30-days postoperative
Outcome measures
| Measure |
Home Intravenous Ertapenem and PICC
n=44 Participants
Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class: carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages \<13; age 13 or greater, then 1 gm daily)
Peripheral inserted central Catheter: All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics.
|
Home Oral Amoxicillin-clavulanate
n=38 Participants
Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate (Drug Class: beta lactam antibiotic) (15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours).
|
|---|---|---|
|
Number of Participants With Wound Infections
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Thirty days following appendectomyNumber of Readmission within 30 days postoperative
Outcome measures
| Measure |
Home Intravenous Ertapenem and PICC
n=44 Participants
Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class: carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages \<13; age 13 or greater, then 1 gm daily)
Peripheral inserted central Catheter: All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics.
|
Home Oral Amoxicillin-clavulanate
n=38 Participants
Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate (Drug Class: beta lactam antibiotic) (15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours).
|
|---|---|---|
|
Number Participants With Readmission Within 30 Days
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Thirty days following appendectomyCost of Hospital services
Outcome measures
| Measure |
Home Intravenous Ertapenem and PICC
n=37 Participants
Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class: carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages \<13; age 13 or greater, then 1 gm daily)
Peripheral inserted central Catheter: All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics.
|
Home Oral Amoxicillin-clavulanate
n=31 Participants
Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate (Drug Class: beta lactam antibiotic) (15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours).
|
|---|---|---|
|
Hospital Charge
|
47564.3 Dollars
Standard Deviation 9057.59
|
34227.79 Dollars
Standard Deviation 8104.65
|
Adverse Events
Home Intravenous Ertapenem and PICC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Home Oral Amoxicillin-clavulanate
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Home Intravenous Ertapenem and PICC
n=44 participants at risk
Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class: carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages \<13; age 13 or greater, then 1 gm daily)
Peripheral inserted central Catheter: All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics.
|
Home Oral Amoxicillin-clavulanate
n=38 participants at risk
Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate (Drug Class: beta lactam antibiotic) (15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours).
|
|---|---|---|
|
Gastrointestinal disorders
Adinamic ileus
|
0.00%
0/44 • 30 days
|
2.6%
1/38 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/44 • 30 days
|
2.6%
1/38 • Number of events 1 • 30 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place