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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-drug Therapy | No Intervention | ceftriaxone/metronidazole | |
| 1-drug Therapy | Experimental | piperacillin-tazobactam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piperacillin, Tazobactam Drug Combination | Drug | Single drug therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Postoperative Intra-abdominal Abscess | Intra-abdominal abscess documented by ultrasound or computerized tomography | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postoperative Surgical Site Infection | surgical site infections including superficial port site infection | 30 days |
| Number of Participants With a Postoperative Readmission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Lee, MD | Phoenix Childrens Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States | ||
| Children's Mercy Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 2-drug Therapy | ceftriaxone/metronidazole - 2-drug regimen (CM) includes once a day dosing of ceftriaxone (50 mg/kg) and metronidazole (30 mg/kg) |
| FG001 | 1-drug Therapy | piperacillin-tazobactam - Single drug regimen (P) includes piperacillin-tazobactam (<40 kg: 100 mg/kg Q8HR, >40 kg: 3000mg Q6HR) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 2-drug Therapy | ceftriaxone/metronidazole |
| BG001 | 1-drug Therapy | piperacillin-tazobactam Piperacillin, Tazobactam Drug Combination: Single drug therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Postoperative Intra-abdominal Abscess | Intra-abdominal abscess documented by ultrasound or computerized tomography | Posted | Count of Participants | Participants | 30 days |
|
|
Assessed up to 30 days postoperatively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2-drug Therapy | ceftriaxone/metronidazole | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perioperative Redness/Edema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Subject developed perioperative redness and edema after operation. Originally given Zosyn which was discontinued and later replaced by another set of antibiotics. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Justin Lee | Phoenix Children's | 6029330016 | jlee8@phoenixchildrens.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2018 | Nov 9, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| ID | Term |
|---|---|
| D000078142 | Tazobactam |
| D010397 | Penicillanic Acid |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
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readmission within 30 days for any gastrointestinal complaints or infectious complications
| 30 days |
| Kansas City |
| Missouri |
| 64108 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Number of Participants With Postoperative Surgical Site Infection | surgical site infections including superficial port site infection | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Number of Participants With a Postoperative Readmission | readmission within 30 days for any gastrointestinal complaints or infectious complications | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 80 |
| 0 |
| 80 |
| 1 |
| 80 |
| EG001 | 1-drug Therapy | piperacillin-tazobactam Piperacillin, Tazobactam Drug Combination: Single drug therapy | 0 | 82 | 0 | 82 | 0 | 82 |
|
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| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D007769 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D010878 | Piperacillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D013457 | Sulfur Compounds |
| D013450 | Sulfones |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |