Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-12-31

Brief Summary

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The major goal of the project is to demonstrate the feasibility of conducting a multi-center randomized clinical trial of antibiotic therapy versus appendectomy for the treatment of patients with acute uncomplicated appendicitis by conducting a single-site pilot study so as to optimize the chance of a large multi-center clinical trial's future success.

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Detailed Description

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This will be a single-site open clinical trial in which subjects with acute uncomplicated appendicitis are randomized to one of two initial treatment strategies, surgery with peri-operative antibiotics or antibiotics alone, with surgical rescue if necessary.

Conditions

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Acute Uncomplicated Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antibiotics

Once-a-day dose of IV/IM ertapenem for at least two days and cefdinir and metronidazole, to complete 10 days total antibiotic therapy.

Group Type EXPERIMENTAL

1 gm IV ertapenem at enrollment

Intervention Type DRUG

1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days

Intervention Type DRUG

Appendectomy

Patients in the surgery therapy arm will only receive one dose of IV ertapenem prior to surgery.

Group Type ACTIVE_COMPARATOR

1 gm IV ertapenem at enrollment

Intervention Type DRUG

Appendectomy

Intervention Type PROCEDURE

Interventions

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1 gm IV ertapenem at enrollment

Intervention Type DRUG

1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days

Intervention Type DRUG

Appendectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult or child ages ≥5 years;
* Diagnosis of acute uncomplicated appendicitis, confirmed by CT, ultrasound and/or MRI performed within 24 hours of consent, as read by an attending radiologist, and confirmed by consultation of an attending surgeon;
* Ability to provide written informed consent (and for subjects ages 5-17, consent from their parent/guardian and assent if applicable); and
* Negative pregnancy test for subjects who are women of childbearing potential.

Exclusion Criteria

* instability/severe sepsis, appendiceal perforation by imaging, serious co-morbidities limiting randomization, pregnancy, and inability to complete the treatment protocol.

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No