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Anti-biotic

Antibiotic Treatment for Appendicitis

Phase 2
Waitlist Available
Led By Nicole M. Chandler, MD
Research Sponsored by Johns Hopkins All Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days postoperatively
Awards & highlights

Study Summary

This trial will explore if placing antibiotics in the abdomen at the time of appendicitis surgery is safe and beneficial for young patients with complicated appendicitis.

Who is the study for?
This trial is for children and teens aged 3-18 with complicated appendicitis, weighing over 20kg, who are about to have their appendix removed. It's not for those with simple appendicitis, severe allergies to penicillin or cephalosporins, kidney issues (CrCl <15mL/min), pregnancy, or certain neurological conditions.Check my eligibility
What is being tested?
The study tests if adding an antibiotic solution into the abdomen after removing the infected fluid during appendix surgery helps in recovery. This is compared to the standard suctioning treatment at Johns Hopkins All Children's Hospital.See study design
What are the potential side effects?
Potential side effects may include reactions to antibiotics like Ceftriaxone such as rash, diarrhea, fungal infections due to altered gut flora, and rarely more serious allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Feasibility of the Use of Antibiotic Solution Instillation Following Intraoperative Diagnosis of Complex Appendicitis as Assessed by Percentage of Eligible Participants Who Complete All Intervention Sessions and Measurement Time Points
Safety of the Use of Antibiotic Solution Instillation Following Intraoperative Diagnosis of Complex Appendicitis as Assessed by Number of Adverse Events

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care and Antibiotic instillation (Arm B)Experimental Treatment2 Interventions
Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy and subsequent instillation of 10ml of intra-peritoneal ceftriaxone (2g)
Group II: Standard of Care (Arm A)Active Control1 Intervention
Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intra-peritoneal Fluid Aspiration
2023
Completed Phase 2
~40
Ceftriaxone
2019
Completed Phase 4
~5020

Find a Location

Who is running the clinical trial?

Johns Hopkins All Children's HospitalLead Sponsor
43 Previous Clinical Trials
5,007,507 Total Patients Enrolled
1 Trials studying Appendicitis
36 Patients Enrolled for Appendicitis
Nicole M. Chandler, MDPrincipal InvestigatorJohns Hopkins All Children's Hospital

Media Library

Ceftriaxone (Anti-biotic) Clinical Trial Eligibility Overview. Trial Name: NCT05470517 — Phase 2
Appendicitis Research Study Groups: Standard of Care (Arm A), Standard of Care and Antibiotic instillation (Arm B)
Appendicitis Clinical Trial 2023: Ceftriaxone Highlights & Side Effects. Trial Name: NCT05470517 — Phase 2
Ceftriaxone (Anti-biotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05470517 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could participants younger than 65 years qualify for this research initiative?

"In accordance with the entry requirements, only participants aged between 3 and 18 are eligble."

Answered by AI

Who can partake in this research experiment?

"To be accepted, applicants must suffer from acute appendicitis and range between the ages of 3 and 18. As such, only 36 patients are being enrolled in this trial."

Answered by AI

What dangers are associated with the Standard of Care and Antibiotic instillation regimen (Arm B)?

"The data collected so far suggests that Standard of Care and Antibiotic instillation (Arm B) is relatively safe, which earned it a score of 2. The Phase 2 trial does not yet have sufficient evidence to confirm efficacy."

Answered by AI

Are individuals currently being admitted to this investigation?

"Affirmative. According to the data posted on clinicaltrials.gov, this scientific experiment commenced recruiting individuals on May 1st 2023 and has since been updated on September 1st 2023. The research is seeking 36 participants from one specific location."

Answered by AI

How many participants are currently being recruited for this experiment?

"Indeed, the clinicaltrials.gov information indicates that this trial is currently enrolling participants and began taking applications on May 1st 2023. Recently updated on September 1st 2023, 36 patients need to be registered from a single site for it to continue."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Antibiotic Instillation in Appendicitis
2023. "Antibiotic Instillation in Appendicitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05470517.
~14 spots leftby Apr 2025
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