Antibiotic Instillation in Appendicitis

NCT05470517 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB00323208
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Complicated Appendicitis; Acute Appendicitis

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to 30 days postoperatively

Study Arms (2)

Standard of Care (Arm A)

ACTIVE COMPARATOR

Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy.

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)

Drug: Ceftriaxone; Procedure: Intra-peritoneal Fluid Aspiration

Interventions

Ceftriaxone DRUG

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.

Also known as: Ceftriaxone sodium

Standard of Care and Antibiotic instillation (Arm B)

Intra-peritoneal Fluid Aspiration PROCEDURE

Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy.

Standard of Care (Arm A); Standard of Care and Antibiotic instillation (Arm B)

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins All Children's Hospital: lead

Study Sites (1)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Ceftriaxone

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Nicole M. Chandler, MD
• Organization: Johns Hopkins All Children's Hospital

nicole.chandler@jhmi.edu

727-767-4170

Study Officials

• Nicole M. Chandler, MD

  Johns Hopkins All Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The surgeon and team administering the treatment will not be blinded; however, patients, patients' families, and hospital caregivers outside of the operating room will be blinded to the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blinded randomized controlled pilot phase 2 study

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 22, 2022
• Study Start: January 5, 2023
• Primary Completion: February 2, 2024
• Study Completion: March 20, 2024
• Last Updated: March 13, 2025
• Results First Posted: March 13, 2025

Record last verified: 2025-02

Locations

US (1)