Trial Outcomes & Findings for Antibiotic Duration in Post-appendectomy Abscess (NCT NCT03795194)

NCT ID: NCT03795194

Last Updated: 2024-03-08

Results Overview

Rate of readmission to the hospital after abscess drainage.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 7 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2024-03-08

Participant Flow

Participant milestones

Measure	8-day 8-day course of ampicillin clavulanate antibiotic ampicillin/clavulanate: FDA-approved antibiotic	4-day 4--day course of ampicillin clavulanate antibiotic ampicillin/clavulanate: FDA-approved antibiotic
Overall Study STARTED	3	4
Overall Study COMPLETED	3	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antibiotic Duration in Post-appendectomy Abscess

Baseline characteristics by cohort

Measure	Arm A (8-day) n=3 Participants In this study, all patients will be treated with the hospital standard of care and receive in-patient treatment for abscess until afebrile and tolerating food for 24 hours. After percutaneous drainage of the abscess, the patient will be randomly assigned to receive either an 8-day regimen (arm A) or a 4-day regimen (arm B) of antibiotics (Diagram 1). Patients will remain on IV ceftriaxone/metronidazole or other broad spectrum antibiotic equivalent until afebrile and tolerating food for 24 hours. Patients will complete their assigned 4- or 8-day regimen with oral ampicillin clavulanate or other broad spectrum antibiotic equivalent. If patients are not afebrile at the completion of their assigned regimen, prescribing an extended course of antibiotics is at the discretion of the treating surgeon. A prescribed oral course of antibiotics may be finished in the hospital or at home if patient is discharged.	Arm B (4-day) n=4 Participants In this study, all patients will be treated with the hospital standard of care and receive in-patient treatment for abscess until afebrile and tolerating food for 24 hours. After percutaneous drainage of the abscess, the patient will be randomly assigned to receive either an 8-day regimen (arm A) or a 4-day regimen (arm B) of antibiotics (Diagram 1). Patients will remain on IV ceftriaxone/metronidazole or other broad spectrum antibiotic equivalent until afebrile and tolerating food for 24 hours. Patients will complete their assigned 4- or 8-day regimen with oral ampicillin clavulanate or other broad spectrum antibiotic equivalent. If patients are not afebrile at the completion of their assigned regimen, prescribing an extended course of antibiotics is at the discretion of the treating surgeon. A prescribed oral course of antibiotics may be finished in the hospital or at home if patient is discharged.	Total n=7 Participants Total of all reporting groups
Age, Continuous	15.34 Years STANDARD_DEVIATION 2.48 • n=5 Participants	9.65 Years STANDARD_DEVIATION 3.56 • n=7 Participants	12.09 Years STANDARD_DEVIATION 4.20 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Rate of readmission to the hospital after abscess drainage.

Outcome measures

Measure	Arm A (8-Day) 30-day Readmission Rate n=3 Participants Rate of readmission to hospital following source control of abscess when treated with antibiotics for 8 days.	Arm B (4-Day) 30-day Readmission Rate n=4 Participants Rate of readmission to hospital following scource control of abscess when treated with antibiotics for 4 days.
Hospital Readmission Rate	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Participants were not readmitted to the hospital after abscess drainage.

How many days patient stays in the hospital if and when they are readmitted after their abscess drainage.

Outcome measures

Outcome data not reported

Adverse Events

8-day

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

4-day

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Coordinator

Phoenix Children's

Phone: 6029331858

Email: zhunteman@phoenixchildrens.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place