Trial · NCT05470517

Antibiotic Instillation in Appendicitis

NCT05470517, Phase 2, Completed, Johns Hopkins All Children's Hospital; results first posted 2025-03-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Antibiotic Instillation in Appendicitis. Trials, record NCT05470517. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05470517

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Antibiotic Instillation in Appendicitis
NCT number: NCT05470517
Status: Completed
Phases: Phase 2
Enrollment: 190 participants, actual
Lead sponsor: Johns Hopkins All Children's Hospital
Conditions: Complicated Appendicitis, Acute Appendicitis
Interventions: Ceftriaxone, Intra-peritoneal Fluid Aspiration
First posted: 2022-07-22
Last updated: 2025-03-13
Results first posted: 2025-03-13

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
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	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.
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	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.
Primary	Safety of the Use of Antibiotic Solution Instillation Following Intraoperative Diagnosis of Complex Appendicitis as Assessed by Number of Adverse Events	Up to 30 days postoperatively	Safety will be determined by adverse events in all participants.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
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	Up to 30 days postoperatively	Patients With Appendicitis Eligible for Study	Participants	COUNT_OF_PARTICIPANTS
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	Up to 30 days postoperatively		percentage of participants	NUMBER
PRIMARY	Safety of the Use of Antibiotic Solution Instillation Following Intraoperative Diagnosis of Complex Appendicitis as Assessed by Number of Adverse Events	Up to 30 days postoperatively		adverse events	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
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 With Appendicitis Eligible for Study	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	Number of Patients With Appendicitis Eligible for Study	Total number of Eligible Patients who Agreed to Participate	190	Participants
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	Standard of Care (Arm A)		100	percentage of participants
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	Standard of Care and Antibiotic Instillation (Arm B)		81	percentage of participants
Safety of the Use of Antibiotic Solution Instillation Following Intraoperative Diagnosis of Complex Appendicitis as Assessed by Number of Adverse Events	Standard of Care (Arm A)		11	adverse events
Safety of the Use of Antibiotic Solution Instillation Following Intraoperative Diagnosis of Complex Appendicitis as Assessed by Number of Adverse Events	Standard of Care and Antibiotic Instillation (Arm B)		17	adverse events

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Standard of Care (Arm A)	16
Overall Study	STARTED	Standard of Care and Antibiotic Instillation (Arm B)	16
Overall Study	COMPLETED	Standard of Care (Arm A)	16
Overall Study	COMPLETED	Standard of Care and Antibiotic Instillation (Arm B)	16
Overall Study	NOT COMPLETED	Standard of Care (Arm A)	0
Overall Study	NOT COMPLETED	Standard of Care and Antibiotic Instillation (Arm B)	0

Source ClinicalTrials.gov

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	laparotomy, lysis of adhesions, omenectomy	Surgical and medical procedures	Standard of Care (Arm A)	0	16	0
other	laparotomy, lysis of adhesions, omenectomy	Surgical and medical procedures	Standard of Care and Antibiotic Instillation (Arm B)	1	16	1
other	post-op skin redness/blotches	Skin and subcutaneous tissue disorders	Standard of Care (Arm A)	0	16	0
other	post-op skin redness/blotches	Skin and subcutaneous tissue disorders	Standard of Care and Antibiotic Instillation (Arm B)	1	16	1
other	abdominal pain	Gastrointestinal disorders	Standard of Care (Arm A)	3	16	3
other	abdominal pain	Gastrointestinal disorders	Standard of Care and Antibiotic Instillation (Arm B)	0	16	0
other	abscess/fluid collection	Infections and infestations	Standard of Care (Arm A)	7	16	7
other	abscess/fluid collection	Infections and infestations	Standard of Care and Antibiotic Instillation (Arm B)	4	16	5
other	non-cardiac chest pain	General disorders	Standard of Care (Arm A)	0	16	0
other	non-cardiac chest pain	General disorders	Standard of Care and Antibiotic Instillation (Arm B)	1	16	1

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard of Care (Arm A)	0	16
Total, all-cause mortality	Standard of Care and Antibiotic Instillation (Arm B)	0	16
Total, other adverse events	Standard of Care (Arm A)	9	16
Total, other adverse events	Standard of Care and Antibiotic Instillation (Arm B)	8	16
Total, serious adverse events	Standard of Care (Arm A)	0	16
Total, serious adverse events	Standard of Care and Antibiotic Instillation (Arm B)	0	16

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Standard of Care and Antibiotic Instillation (Arm B) vs Standard of Care (Arm A): deaths from any cause	Trial comparisons
Standard of Care and Antibiotic Instillation (Arm B) vs Standard of Care (Arm A): serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05470517

GET https://conductscience.org/api/trials/v1/NCT05470517/events?page=2

API reference For AI assistants