Acute Uncomplicated AppendicitisEarly Phase 1NCT02447224
Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis
A Early Phase 1 study testing 1 gm IV ertapenem at enrollment, 1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days and Appendectomy in people with Acute Uncomplicated Appendicitis, run by Olive View-UCLA Education & Research Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Acute Uncomplicated Appendicitis
- What is being tested?
- 1 gm IV ertapenem at enrollment, 1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days and Appendectomy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 31 Dec 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- instability/severe sepsis, appendiceal perforation by imaging, serious co-morbidities limiting randomization, pregnancy, and inability to complete the treatment protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Olive View-UCLA Medical Center
Sylmar, California, 91342
About this study
Official title: A Pilot Study for a Randomized Trial of Antibiotics Versus Surgery for Treatment of Patients With Acute Uncomplicated Appendicitis
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.
Read the detailed description
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
- Acute Uncomplicated Appendicitis
- Being tested
- 1 gm IV ertapenem at enrollment, 1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days, Appendectomy
- Keywords
- appendicitis, non operative management, appendectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 gm IV ertapenem at enrollmentDrug
1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 daysDrug
AppendectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics | Experimental | Once-a-day dose of IV/IM ertapenem for at least two days and cefdinir and metronidazole, to complete 10 days total antibiotic therapy. Receives: Drug: 1 gm IV ertapenem at enrollment; Drug: 1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days |
| Appendectomy | Active comparator | Patients in the surgery therapy arm will only receive one dose of IV ertapenem prior to surgery. Receives: Drug: 1 gm IV ertapenem at enrollment; Procedure: Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Complications
The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) criteria and definitions for major complications will be used. In addition, antibiotic related complications will be evaluated, i.e., antibiotic-related/Clostridium difficile colitis and antibiotic reaction requiring hospitalization.
Measured: 30 days
Secondary outcomes (2)
Recurrent appendicitis
Measured: 30 days
QOL outcomes
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Uncomplicated AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olive View-UCLA Education & Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A. Talan, Olive View-UCLA Education & Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447224
- Sponsor's protocol ID
- 1R21DK102048
- Status last verified
- Apr 2018
- First submitted
- 14 May 2015
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for a Randomized Trial of Antibiotics Versus Surgery for Treatment of Patients With Acute Uncomplicated Appendicitis
- ClinicalTrials.gov ID
- NCT02447224
- Acronym / sponsor ID
- 1R21DK102048
- Conditions
- Acute Uncomplicated Appendicitis
- Keywords
- appendicitis, non operative management, appendectomy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Olive View-UCLA Education & Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2015 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 18 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics | Experimental | Drug: 1 gm IV ertapenem at enrollment, Drug: 1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 daysOnce-a-day dose of IV/IM ertapenem for at least two days and cefdinir and metronidazole, to complete 10 days total antibiotic therapy. |
| Appendectomy | Active comparator | Drug: 1 gm IV ertapenem at enrollment, Procedure: AppendectomyPatients in the surgery therapy arm will only receive one dose of IV ertapenem prior to surgery. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- instability/severe sepsis, appendiceal perforation by imaging, serious co-morbidities limiting randomization, pregnancy, and inability to complete the treatment protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 gm IV ertapenem at enrollment | Drug | Antibiotics, Appendectomy |
| 1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days | Drug | Antibiotics |
| Appendectomy | Procedure or surgery | Appendectomy |
Primary outcome
Major Complications
Time frame: 30 days
The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) criteria and definitions for major complications will be used. In addition, antibiotic related complications will be evaluated, i.e., antibiotic-related/Clostridium difficile colitis and antibiotic reaction requiring hospitalization.
2 secondary outcomes
Recurrent appendicitis
Time frame: 30 days
QOL outcomes
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
Related trials for Acute Uncomplicated Appendicitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 1 gm IV ertapenem at enrollment, 1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days and Appendectomy in people with Acute Uncomplicated Appendicitis, run by Olive View-UCLA Education & Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.