Trial Outcomes & Findings for Antibiotic Instillation in Appendicitis (NCT NCT05470517)
NCT ID: NCT05470517
Last Updated: 2025-03-13
Results Overview
The study will be deemed feasible if \>50% of potential participants agree to participate. This benchmark is based on a previous similar study completed in this population.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
190 participants
Primary outcome timeframe
Up to 30 days postoperatively
Results posted on
2025-03-13
Participant Flow
Those eligible preoperatively (n=337) were approached for consent with the caveat that they are eligible intraoperatively (complicated appendicitis). The number of patients who were consented (190) is not the same as the number of patients who were randomized (32). The remaining 158 eligible participants were not randomized due to intraoperative findings (n=156) and screen failures (n=2).
Participant milestones
| Measure |
Standard of Care (Arm A)
Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy.
Intra-peritoneal Fluid Aspiration: Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy.
|
Standard of Care and Antibiotic Instillation (Arm B)
Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy and subsequent instillation of 10ml of intra-peritoneal ceftriaxone (2g)
Ceftriaxone: Ceftriaxone is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous, intramuscular, or intra-peritoneal administration.
Ceftriaxone is a white powder, which is soluble in water. In this study ceftriaxone crystalline powder will be dissolved in 0.9% sodium chloride solution prior to intra-peritoneal instillation.
Antibiotic instillation will be introduced into the RLQ/pelvis after the appendectomy is completed and all intra-peritoneal fluid is aspirated. Ceftriaxone solution will be used depending on availability and pharmacy stock for use at Johns Hopkins All Children's Hospital. The ceftriaxone powder (2g) will be dissolved in 9ml of sterile normal saline, for a total instillation volume of 10ml. This fluid will then be instilled and left to dwell in the area of the peritoneal cavity where the appendix was removed.
Intra-peritoneal Fluid Aspiration: Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antibiotic Instillation in Appendicitis
Baseline characteristics by cohort
| Measure |
Standard of Care (Arm A)
n=16 Participants
Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy.
Intra-peritoneal Fluid Aspiration: Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy.
|
Standard of Care and Antibiotic Instillation (Arm B)
n=16 Participants
Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy and subsequent instillation of 10ml of intra-peritoneal ceftriaxone (2g)
Ceftriaxone: Ceftriaxone is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous, intramuscular, or intra-peritoneal administration.
Ceftriaxone is a white powder, which is soluble in water. In this study ceftriaxone crystalline powder will be dissolved in 0.9% sodium chloride solution prior to intra-peritoneal instillation.
Antibiotic instillation will be introduced into the RLQ/pelvis after the appendectomy is completed and all intra-peritoneal fluid is aspirated. Ceftriaxone solution will be used depending on availability and pharmacy stock for use at Johns Hopkins All Children's Hospital. The ceftriaxone powder (2g) will be dissolved in 9ml of sterile normal saline, for a total instillation volume of 10ml. This fluid will then be instilled and left to dwell in the area of the peritoneal cavity where the appendix was removed.
Intra-peritoneal Fluid Aspiration: Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.96 years
STANDARD_DEVIATION 3.77 • n=5 Participants
|
11.58 years
STANDARD_DEVIATION 3.96 • n=7 Participants
|
11.77 years
STANDARD_DEVIATION 3.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 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
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days postoperativelyPopulation: Patients With Appendicitis Eligible for Study
The study will be deemed feasible if \>50% of potential participants agree to participate. This benchmark is based on a previous similar study completed in this population.
Outcome measures
| Measure |
Number of Patients With Appendicitis Eligible for Study
n=337 Participants
Patients between the ages of 3 and 18 years old who present with acute appendicitis that will be managed with operative intervention.
|
Standard of Care and Antibiotic Instillation (Arm B)
Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy and subsequent instillation of 10ml of intra-peritoneal ceftriaxone (2g)
Ceftriaxone: Ceftriaxone is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous, intramuscular, or intra-peritoneal administration.
Ceftriaxone is a white powder, which is soluble in water. In this study ceftriaxone crystalline powder will be dissolved in 0.9% sodium chloride solution prior to intra-peritoneal instillation.
Antibiotic instillation will be introduced into the RLQ/pelvis after the appendectomy is completed and all intra-peritoneal fluid is aspirated. Ceftriaxone solution will be used depending on availability and pharmacy stock for use at Johns Hopkins All Children's Hospital. The ceftriaxone powder (2g) will be dissolved in 9ml of sterile normal saline, for a total instillation volume of 10ml. This fluid will then be instilled and left to dwell in the area of the peritoneal cavity where the appendix was removed.
Intra-peritoneal Fluid Aspiration: Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy.
|
|---|---|---|
|
Feasibility of the Use of Antibiotic Solution Instillation Following Intraoperative Diagnosis of Complex Appendicitis as Assessed by Percentage of Eligible Participants Who Agree to Participate
Number of Patients Eligible who Declined Study Participation
|
147 Participants
|
—
|
|
Feasibility of the Use of Antibiotic Solution Instillation Following Intraoperative Diagnosis of Complex Appendicitis as Assessed by Percentage of Eligible Participants Who Agree to Participate
Total number of Eligible Patients who Agreed to Participate
|
190 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 30 days postoperativelyThe study will be deemed feasible if at least 75% of randomized participants complete all intervention sessions and measurement time points per study protocol. This benchmark is based on a previous similar study completed in this population.
Outcome measures
| Measure |
Number of Patients With Appendicitis Eligible for Study
n=16 Participants
Patients between the ages of 3 and 18 years old who present with acute appendicitis that will be managed with operative intervention.
|
Standard of Care and Antibiotic Instillation (Arm B)
n=16 Participants
Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy and subsequent instillation of 10ml of intra-peritoneal ceftriaxone (2g)
Ceftriaxone: Ceftriaxone is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous, intramuscular, or intra-peritoneal administration.
Ceftriaxone is a white powder, which is soluble in water. In this study ceftriaxone crystalline powder will be dissolved in 0.9% sodium chloride solution prior to intra-peritoneal instillation.
Antibiotic instillation will be introduced into the RLQ/pelvis after the appendectomy is completed and all intra-peritoneal fluid is aspirated. Ceftriaxone solution will be used depending on availability and pharmacy stock for use at Johns Hopkins All Children's Hospital. The ceftriaxone powder (2g) will be dissolved in 9ml of sterile normal saline, for a total instillation volume of 10ml. This fluid will then be instilled and left to dwell in the area of the peritoneal cavity where the appendix was removed.
Intra-peritoneal Fluid Aspiration: Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy.
|
|---|---|---|
|
Feasibility of the Use of Antibiotic Solution Instillation Following Intraoperative Diagnosis of Complex Appendicitis as Assessed by Percentage of Randomized Participants Who Complete All Intervention Sessions and Measurement Time Points
|
100 percentage of participants
|
81 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 30 days postoperativelySafety will be determined by adverse events in all participants.
Outcome measures
| Measure |
Number of Patients With Appendicitis Eligible for Study
n=16 Participants
Patients between the ages of 3 and 18 years old who present with acute appendicitis that will be managed with operative intervention.
|
Standard of Care and Antibiotic Instillation (Arm B)
n=16 Participants
Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy and subsequent instillation of 10ml of intra-peritoneal ceftriaxone (2g)
Ceftriaxone: Ceftriaxone is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous, intramuscular, or intra-peritoneal administration.
Ceftriaxone is a white powder, which is soluble in water. In this study ceftriaxone crystalline powder will be dissolved in 0.9% sodium chloride solution prior to intra-peritoneal instillation.
Antibiotic instillation will be introduced into the RLQ/pelvis after the appendectomy is completed and all intra-peritoneal fluid is aspirated. Ceftriaxone solution will be used depending on availability and pharmacy stock for use at Johns Hopkins All Children's Hospital. The ceftriaxone powder (2g) will be dissolved in 9ml of sterile normal saline, for a total instillation volume of 10ml. This fluid will then be instilled and left to dwell in the area of the peritoneal cavity where the appendix was removed.
Intra-peritoneal Fluid Aspiration: Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy.
|
|---|---|---|
|
Safety of the Use of Antibiotic Solution Instillation Following Intraoperative Diagnosis of Complex Appendicitis as Assessed by Number of Adverse Events
|
11 adverse events
|
17 adverse events
|
Adverse Events
Standard of Care (Arm A)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Standard of Care and Antibiotic Instillation (Arm B)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care (Arm A)
n=16 participants at risk
Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy.
Intra-peritoneal Fluid Aspiration: Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy.
|
Standard of Care and Antibiotic Instillation (Arm B)
n=16 participants at risk
Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy and subsequent instillation of 10ml of intra-peritoneal ceftriaxone (2g)
Ceftriaxone: Ceftriaxone is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous, intramuscular, or intra-peritoneal administration.
Ceftriaxone is a white powder, which is soluble in water. In this study ceftriaxone crystalline powder will be dissolved in 0.9% sodium chloride solution prior to intra-peritoneal instillation.
Antibiotic instillation will be introduced into the RLQ/pelvis after the appendectomy is completed and all intra-peritoneal fluid is aspirated. Ceftriaxone solution will be used depending on availability and pharmacy stock for use at Johns Hopkins All Children's Hospital. The ceftriaxone powder (2g) will be dissolved in 9ml of sterile normal saline, for a total instillation volume of 10ml. This fluid will then be instilled and left to dwell in the area of the peritoneal cavity where the appendix was removed.
Intra-peritoneal Fluid Aspiration: Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy.
|
|---|---|---|
|
Surgical and medical procedures
laparotomy, lysis of adhesions, omenectomy
|
0.00%
0/16 • Up to 30 days post operatively
|
6.2%
1/16 • Number of events 1 • Up to 30 days post operatively
|
|
Skin and subcutaneous tissue disorders
post-op skin redness/blotches
|
0.00%
0/16 • Up to 30 days post operatively
|
6.2%
1/16 • Number of events 1 • Up to 30 days post operatively
|
|
Gastrointestinal disorders
abdominal pain
|
18.8%
3/16 • Number of events 3 • Up to 30 days post operatively
|
0.00%
0/16 • Up to 30 days post operatively
|
|
Infections and infestations
abscess/fluid collection
|
43.8%
7/16 • Number of events 7 • Up to 30 days post operatively
|
25.0%
4/16 • Number of events 5 • Up to 30 days post operatively
|
|
General disorders
non-cardiac chest pain
|
0.00%
0/16 • Up to 30 days post operatively
|
6.2%
1/16 • Number of events 1 • Up to 30 days post operatively
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/16 • Up to 30 days post operatively
|
6.2%
1/16 • Number of events 1 • Up to 30 days post operatively
|
|
Infections and infestations
bladder infection
|
0.00%
0/16 • Up to 30 days post operatively
|
6.2%
1/16 • Number of events 1 • Up to 30 days post operatively
|
|
Surgical and medical procedures
drain exchange/placement
|
0.00%
0/16 • Up to 30 days post operatively
|
6.2%
1/16 • Number of events 2 • Up to 30 days post operatively
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.00%
0/16 • Up to 30 days post operatively
|
6.2%
1/16 • Number of events 1 • Up to 30 days post operatively
|
|
Gastrointestinal disorders
small intestinal obstruction
|
6.2%
1/16 • Number of events 1 • Up to 30 days post operatively
|
0.00%
0/16 • Up to 30 days post operatively
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/16 • Up to 30 days post operatively
|
6.2%
1/16 • Number of events 3 • Up to 30 days post operatively
|
|
Renal and urinary disorders
hematuria
|
0.00%
0/16 • Up to 30 days post operatively
|
6.2%
1/16 • Number of events 1 • Up to 30 days post operatively
|
Additional Information
Nicole M. Chandler, MD
Johns Hopkins All Children's Hospital
Phone: 727-767-4170
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place