Phase 2 N=32 Randomized Single-blind Treatment

Antibiotic Instillation in Appendicitis

Complicated Appendicitis · Acute Appendicitis

Bottom Line

View on ClinicalTrials.gov: NCT05470517 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: 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 — 147; 190 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ceftriaxone (Drug); Intra-peritoneal Fluid Aspiration (Procedure)
Age: Pediatric, Adult · 3+ yrs
Sex: All
Sponsor: Johns Hopkins All Children's Hospital
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	147; 190	—
PRIMARY 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; 81	—
PRIMARY Safety of the Use of Antibiotic Solution Instillation Following Intraoperative Diagnosis of Complex Appendicitis as Assessed by Number of Adverse Events	11; 17	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05470517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.