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Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

Randomized Control Trial: Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03289351
Enrollment
162
Registered
2017-09-20
Start date
2017-05-22
Completion date
2023-11-07
Last updated
2024-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perforated Appendicitis, Postoperative Infection

Brief summary

After appendix has been removed for perforated appendicitis, patients will receive postoperative antibiotics. In the last 5 years, the literature has transitioned from a 3 -drug therapy to 2-drug therapy. Now there is a recent literature suggesting a single-drug therapy may be safe and adequate. In fact, using zosyn (piperacillin-tazobactam) as a single-drug therapy, there are additional benefits of simplicity, compliance, and lower infectious complications. Currently surgeons are already using both 2-drug regimen (ceftriaxone/metronidazole) and single-drug regimen (zosyn) interchangeable as both are FDA approved and regulated antibiotics for intra-abdominal infection. There is a clear need to compare outcomes between these two options.

Detailed description

The diagnosis of perforated appendicitis will be documented intraoperatively with photos of extraluminal fecal contents or visible holes on the appendix. Patients will be randomized to 121 in each arm. Postoperative antibiotic therapy option will be decided based on blinded sequence model. 30 day postoperative follow up visit or calls will be made to assess and collect infectious complications.

Interventions

DRUGPiperacillin, Tazobactam Drug Combination

Single drug therapy

Sponsors

Phoenix Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Postoperative Perforated Appendicitis (documented by intraoperative photo) * Postoperative Laparoscopic Appendectomy

Exclusion criteria

* Nonperforated Gangrenous Appendicitis * Nonperforated Purulent Appendicitis * Open Appendectomy

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With a Postoperative Intra-abdominal Abscess30 daysIntra-abdominal abscess documented by ultrasound or computerized tomography

Secondary

MeasureTime frameDescription
Number of Participants With Postoperative Surgical Site Infection30 dayssurgical site infections including superficial port site infection
Number of Participants With a Postoperative Readmission30 daysreadmission within 30 days for any gastrointestinal complaints or infectious complications

Countries

United States

Participant flow

Participants by arm

ArmCount
2-drug Therapy
ceftriaxone/metronidazole
80
1-drug Therapy
piperacillin-tazobactam Piperacillin, Tazobactam Drug Combination: Single drug therapy
82
Total162

Baseline characteristics

Characteristic2-drug Therapy1-drug TherapyTotal
Age, Categorical
<=18 years
80 Participants82 Participants162 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
80 Participants82 Participants162 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
80 Participants82 Participants162 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
30 Participants36 Participants66 Participants
Sex: Female, Male
Male
50 Participants46 Participants96 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 800 / 82
other
Total, other adverse events
1 / 800 / 82
serious
Total, serious adverse events
0 / 800 / 82

Outcome results

Primary

Number of Participants With a Postoperative Intra-abdominal Abscess

Intra-abdominal abscess documented by ultrasound or computerized tomography

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
2-drug TherapyNumber of Participants With a Postoperative Intra-abdominal Abscess19 Participants
1-drug TherapyNumber of Participants With a Postoperative Intra-abdominal Abscess5 Participants
Secondary

Number of Participants With a Postoperative Readmission

readmission within 30 days for any gastrointestinal complaints or infectious complications

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
2-drug TherapyNumber of Participants With a Postoperative Readmission11 Participants
1-drug TherapyNumber of Participants With a Postoperative Readmission4 Participants
Secondary

Number of Participants With Postoperative Surgical Site Infection

surgical site infections including superficial port site infection

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
2-drug TherapyNumber of Participants With Postoperative Surgical Site Infection4 Participants
1-drug TherapyNumber of Participants With Postoperative Surgical Site Infection4 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026