Complicated AppendicitisPhase 2NCT05470517
Antibiotic Instillation in Appendicitis
A Phase 2 study testing Ceftriaxone and Intra-peritoneal Fluid Aspiration in people with Complicated Appendicitis and Acute Appendicitis, run by Johns Hopkins All Children's Hospital at 1 site in United States.
Trial summary
Appendicitis (inflammation of the wall of the appendix, causing pain and tenderness in the abdomen) has a range of severity that goes from simple to complicated. Complicated appendicitis may present with infected fluid inside of the abdomen or a perforation or hole in the intestines. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Complicated Appendicitis, Acute Appendicitis
- What is being tested?
- Ceftriaxone and Intra-peritoneal Fluid Aspiration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2023to 20 Mar 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with acute appendicitis and are scheduled to undergo urgent appendectomy
- Between 3-18 years of age at time of appendectomy
- Has intraoperative findings of complex appendicitis defined by: visible hole in the appendix, extra-luminal fecalith, diffuse fibropurulent exudate outside the RLQ/pelvis, or intraperitoneal abscess
- Weighs equal to or greater than 20kg at time of surgery
Who cannot join
- Pregnant
- Has a penicillin or cephalosporin allergy that is severe or anaphylactic in nature, prohibiting the use of these antibiotics
- Has simple appendicitis
- Undergoes appendectomy following failed or planned medical management of appendicitis
- Has impaired renal function (CrCl <15mL/min)
- Has history of neurological conditions such as encephalopathy, seizures, myoclonus and non-convulsive status epilepticus
- Has a known inability to complete a 30-day postoperative follow up
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
About this study
Official title: Antibiotic Instillation in Acute Complex Appendicitis for Prevention of Deep Space Surgical Site Infections
Appendicitis (inflammation of the wall of the appendix, causing pain and tenderness in the abdomen) has a range of severity that goes from simple to complicated. Complicated appendicitis may present with infected fluid inside of the abdomen or a perforation or hole in the intestines.
This research is being done to determine if placing an antibiotic solution in the abdomen at the time the appendix is removed is a safe procedure in patients between the ages of 3 and 18 years old with findings of complicated appendicitis.
Johns Hopkins All Children's Hospital (JHACH)'s current standard of care for patients with complicated appendicitis includes suctioning the infected fluid out of the abdomen at the time the appendix is removed. As part of this study, the investigators would like to see if patients with complicated appendicitis will benefit from routine care plus leaving an antibiotic solution inside the abdomen, after fully suctioning the infected fluid out of the abdomen.
Read the detailed description
Appendicitis is one of the most common surgical diagnoses in the pediatric population and the most common surgical emergency in children. In complex appendicitis, the sequelae have progressed beyond the confines of the organ, and have led to purulent fluid in the intra-abdominal space, spillage of intestinal contents, or gross perforation of the appendix. Complicated appendicitis occurs in up to 20% of cases and is associated with a much higher morbidity and mortality. Previous studies have shown that local treatment of peritonitis associated with peritoneal dialysis (PD) catheters with intra-peritoneal antibiotics has had significant improvement of outcomes. The intra-peritoneal route is preferable as compared to oral and intravenous antibiotic administration due to elevated local levels of the antibiotic above the minimum inhibitory concentration while avoiding venipuncture and systemic side effects. There is minimal risk associated with involvement in this study given that the investigators will be screening for any history of allergies to penicillin or cephalosporins, and excluding these patients. Ceftriaxone is commercially available, has a low risk profile, and is generally well tolerated with minimal side effects.
The investigators' treatment period will include a one-time intra-operative dose of intra-peritoneal ceftriaxone (or an appropriate second or third generation cephalosporin to be designated at the discretion of the institutional Antibiotic Stewardship committee should ceftriaxone be unavailable). Typical dosing strategies for intra-peritoneal ceftriaxone administration occur on a daily basis, so the investigators' treatment period will also include the 24 hours following intra-peritoneal administration of ceftriaxone. All patients diagnosed with acute complicated appendicitis intra-operatively, and entered into the investigators' study, will also receive a minimum 48 hours of intravenous antibiotics as an inpatient, allowing for continued observation. The investigators will be treating pediatric patients who are intra-operatively diagnosed with complex appendicitis, as defined by any of the following: visible hole in the appendix, extra-luminal fecalith, diffuse fibropurulent exudate outside the right lower quadrant (RLQ)/pelvis, or intraperitoneal abscess. All patients will have been admitted to Johns Hopkins All Children's Hospital with a diagnosis of acute appendicitis prior to surgical intervention. Patients will then be randomized once diagnosed with complex appendicitis intra-operatively. Patients with allergies to penicillin or cephalosporins will be excluded pre-operatively, as well as patients who do not meet the weight requirement, are pregnant, being treated non-operatively, and those who have been intra-operatively diagnosed with simple appendicitis.
- Conditions
- Complicated Appendicitis, Acute Appendicitis
- Being tested
- Ceftriaxone, Intra-peritoneal Fluid Aspiration
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftriaxoneDrug
Also called Ceftriaxone sodium
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 AspirationProcedure or surgery
Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (Arm A) | Active comparator | Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy. Receives: Procedure: Intra-peritoneal Fluid Aspiration |
| Standard of Care and Antibiotic instillation (Arm B) | Experimental | Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy and subsequent instillation of 10ml of intra-peritoneal ceftriaxone (2g) Receives: Drug: Ceftriaxone; Procedure: Intra-peritoneal Fluid Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Up to 30 days postoperatively
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
The 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.
Measured: Up to 30 days postoperatively
Safety of the Use of Antibiotic Solution Instillation Following Intraoperative Diagnosis of Complex Appendicitis as Assessed by Number of Adverse Events
Safety will be determined by adverse events in all participants.
Measured: Up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start5 Jan 2023
- Primary completion2 Feb 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Complicated AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blinded randomized controlled pilot phase 2 study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole M. Chandler, MD, Principal investigator, Johns Hopkins All Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470517
- Sponsor's protocol ID
- IRB00323208
- Status last verified
- Feb 2025
- First submitted
- 19 Jul 2022
- Last updated
- 13 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Instillation in Acute Complex Appendicitis for Prevention of Deep Space Surgical Site Infections
- ClinicalTrials.gov ID
- NCT05470517
- Acronym / sponsor ID
- IRB00323208
- Conditions
- Complicated Appendicitis, Acute Appendicitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Johns Hopkins All Children's HospitalUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 22 Jul 2022 (actual)
- Results
- Posted 13 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Appendicitis (inflammation of the wall of the appendix, causing pain and tenderness in the abdomen) has a range of severity that goes from simple to complicated. Complicated appendicitis may present with infected fluid inside of the abdomen or a perforation or hole in the intestines.
This research is being done to determine if placing an antibiotic solution in the abdomen at the time the appendix is removed is a safe procedure in patients between the ages of 3 and 18 years old with findings of complicated appendicitis.
Johns Hopkins All Children's Hospital (JHACH)'s current standard of care for patients with complicated appendicitis includes suctioning the infected fluid out of the abdomen at the time the appendix is removed. As part of this study, the investigators would like to see if patients with complicated appendicitis will benefit from routine care plus leaving an antibiotic solution inside the abdomen, after fully suctioning the infected fluid out of the abdomen.
Detailed description
Appendicitis is one of the most common surgical diagnoses in the pediatric population and the most common surgical emergency in children. In complex appendicitis, the sequelae have progressed beyond the confines of the organ, and have led to purulent fluid in the intra-abdominal space, spillage of intestinal contents, or gross perforation of the appendix. Complicated appendicitis occurs in up to 20% of cases and is associated with a much higher morbidity and mortality. Previous studies have shown that local treatment of peritonitis associated with peritoneal dialysis (PD) catheters with intra-peritoneal antibiotics has had significant improvement of outcomes. The intra-peritoneal route is preferable as compared to oral and intravenous antibiotic administration due to elevated local levels of the antibiotic above the minimum inhibitory concentration while avoiding venipuncture and systemic side effects. There is minimal risk associated with involvement in this study given that the investigators will be screening for any history of allergies to penicillin or cephalosporins, and excluding these patients. Ceftriaxone is commercially available, has a low risk profile, and is generally well tolerated with minimal side effects.
The investigators' treatment period will include a one-time intra-operative dose of intra-peritoneal ceftriaxone (or an appropriate second or third generation cephalosporin to be designated at the discretion of the institutional Antibiotic Stewardship committee should ceftriaxone be unavailable). Typical dosing strategies for intra-peritoneal ceftriaxone administration occur on a daily basis, so the investigators' treatment period will also include the 24 hours following intra-peritoneal administration of ceftriaxone. All patients diagnosed with acute complicated appendicitis intra-operatively, and entered into the investigators' study, will also receive a minimum 48 hours of intravenous antibiotics as an inpatient, allowing for continued observation. The investigators will be treating pediatric patients who are intra-operatively diagnosed with complex appendicitis, as defined by any of the following: visible hole in the appendix, extra-luminal fecalith, diffuse fibropurulent exudate outside the right lower quadrant (RLQ)/pelvis, or intraperitoneal abscess. All patients will have been admitted to Johns Hopkins All Children's Hospital with a diagnosis of acute appendicitis prior to surgical intervention. Patients will then be randomized once diagnosed with complex appendicitis intra-operatively. Patients with allergies to penicillin or cephalosporins will be excluded pre-operatively, as well as patients who do not meet the weight requirement, are pregnant, being treated non-operatively, and those who have been intra-operatively diagnosed with simple appendicitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blinded randomized controlled pilot phase 2 study
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (Arm A) | Active comparator | Procedure: Intra-peritoneal Fluid AspirationIntra-operative aspiration of intra-peritoneal fluid after successful appendectomy. |
| Standard of Care and Antibiotic instillation (Arm B) | Experimental | Drug: Ceftriaxone, Procedure: Intra-peritoneal Fluid AspirationIntra-operative aspiration of intra-peritoneal fluid after successful appendectomy and subsequent instillation of 10ml of intra-peritoneal ceftriaxone (2g) |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosed with acute appendicitis and are scheduled to undergo urgent appendectomy
- Between 3-18 years of age at time of appendectomy
- Has intraoperative findings of complex appendicitis defined by: visible hole in the appendix, extra-luminal fecalith, diffuse fibropurulent exudate outside the RLQ/pelvis, or intraperitoneal abscess
- Weighs equal to or greater than 20kg at time of surgery
Key exclusion criteria (7 listed)
- Pregnant
- Has a penicillin or cephalosporin allergy that is severe or anaphylactic in nature, prohibiting the use of these antibiotics
- Has simple appendicitis
- Undergoes appendectomy following failed or planned medical management of appendicitis
- Has impaired renal function (CrCl <15mL/min)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeftriaxoneAlso: Ceftriaxone sodiumCeftriaxone 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. | Drug | Standard of Care and Antibiotic instillation (Arm B) |
| Intra-peritoneal Fluid AspirationIntra-operative aspiration of intra-peritoneal fluid after successful appendectomy. | Procedure or surgery | Standard of Care (Arm A), Standard of Care and Antibiotic instillation (Arm B) |
Primary outcome
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
Time frame: Up to 30 days postoperatively
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.
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
Time frame: Up to 30 days postoperatively
The 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.
Safety of the Use of Antibiotic Solution Instillation Following Intraoperative Diagnosis of Complex Appendicitis as Assessed by Number of Adverse Events
Time frame: Up to 30 days postoperatively
Safety will be determined by adverse events in all participants.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Complicated Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
RecruitingPhase 4
Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics
Laparoscopic Appendectomy, Complicated Appendicitis
Recruiting
Oral Lactulose for Gastrointestinal Recovery After Complex Appendectomy
Ileus Postoperative, Gastrointestinal Function
Not yet recruitingObservational study
Laparoscopic Versus Open Appendectomy Plus Peritoneal Lavage for Acute Complicated Appendicitis Patients With Diffuse Peritonitis
Acute Complicated Appendicitis With Diffuse Peritonitis
Not yet recruitingObservational study
Peri-appendiceal Abscess and Phlegmon in Acute Complicated Appendicitis Patients
Acute Complicated Appendicitis With Peri-appendiceal Abscess or Phlegmon
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole M. Chandler, MD principal investigator
Johns Hopkins All Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ceftriaxone and Intra-peritoneal Fluid Aspiration in people with Complicated Appendicitis and Acute Appendicitis, run by Johns Hopkins All Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Up to 30 days postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025; AzTrials last refreshed its copy on 27 Oct 2026.