Trial Outcomes & Findings for Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis (NCT NCT03289351)

NCT ID: NCT03289351

Last Updated: 2024-01-12

Results Overview

Intra-abdominal abscess documented by ultrasound or computerized tomography

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 162 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2024-01-12

Participant Flow

Participant milestones

Measure	2-drug Therapy ceftriaxone/metronidazole - 2-drug regimen (CM) includes once a day dosing of ceftriaxone (50 mg/kg) and metronidazole (30 mg/kg)	1-drug Therapy piperacillin-tazobactam - Single drug regimen (P) includes piperacillin-tazobactam (\<40 kg: 100 mg/kg Q8HR, \>40 kg: 3000mg Q6HR)
Overall Study STARTED	80	82
Overall Study COMPLETED	80	82
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

Baseline characteristics by cohort

Measure	2-drug Therapy n=80 Participants ceftriaxone/metronidazole	1-drug Therapy n=82 Participants piperacillin-tazobactam Piperacillin, Tazobactam Drug Combination: Single drug therapy	Total n=162 Participants Total of all reporting groups
Age, Categorical <=18 years	80 Participants n=5 Participants	82 Participants n=7 Participants	162 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	36 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	46 Participants n=7 Participants	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	80 Participants n=5 Participants	82 Participants n=7 Participants	162 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	80 Participants n=5 Participants	82 Participants n=7 Participants	162 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Intra-abdominal abscess documented by ultrasound or computerized tomography

Outcome measures

Measure	2-drug Therapy n=80 Participants ceftriaxone/metronidazole	1-drug Therapy n=82 Participants piperacillin-tazobactam Piperacillin, Tazobactam Drug Combination: Single drug therapy
Number of Participants With a Postoperative Intra-abdominal Abscess	19 Participants	5 Participants

SECONDARY outcome

Timeframe: 30 days

surgical site infections including superficial port site infection

Outcome measures

Measure	2-drug Therapy n=80 Participants ceftriaxone/metronidazole	1-drug Therapy n=82 Participants piperacillin-tazobactam Piperacillin, Tazobactam Drug Combination: Single drug therapy
Number of Participants With Postoperative Surgical Site Infection	4 Participants	4 Participants

SECONDARY outcome

Timeframe: 30 days

readmission within 30 days for any gastrointestinal complaints or infectious complications

Outcome measures

Measure	2-drug Therapy n=80 Participants ceftriaxone/metronidazole	1-drug Therapy n=82 Participants piperacillin-tazobactam Piperacillin, Tazobactam Drug Combination: Single drug therapy
Number of Participants With a Postoperative Readmission	11 Participants	4 Participants

Adverse Events

2-drug Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

1-drug Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	2-drug Therapy n=80 participants at risk ceftriaxone/metronidazole	1-drug Therapy n=82 participants at risk piperacillin-tazobactam Piperacillin, Tazobactam Drug Combination: Single drug therapy
Skin and subcutaneous tissue disorders Perioperative Redness/Edema	1.2% 1/80 • Number of events 1 • Assessed up to 30 days postoperatively.	0.00% 0/82 • Assessed up to 30 days postoperatively.

Additional Information

Dr. Justin Lee

Phoenix Children's

Phone: 6029330016

Email: jlee8@phoenixchildrens.com

Results disclosure agreements

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