AppendicitisPhase 4NCT00236912
A Study Comparing Safety and Efficacy of Levofloxacin and Metronidazole Versus Piperacillin/Tazobactam in Treating Complicated Appendicitis
A Phase 4 study testing levofloxacin; metronidazole in people with Appendicitis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to compare the efficacy and safety of two treatment regimens in treating patients with complicated appendicitis. Appendicitis requires antibiotic treatment when the appendix ruptures (complicated appendicitis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis
- What is being tested?
- levofloxacin; metronidazole
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Sep 2004
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Two or more symptoms of acute appendicitis for at least 24 hours or radiologic evidence of complicated appendicitis
- Able to take medicine orally after recovering from surgery
- If female, using birth control
Who cannot join
- History of allergy to any study medication
- Life expectancy < 72 hours
- APACHE II (health) score > 25
- Neutropenic (low white blood cell count)
- HIV positive with current or past CD4 count < 200/mm^3
- Low platelet count (bleeds easily)
- Malnourished with low albumin
- Condition requiring use of major tranquilizers
About this study
Official title: A Multi-center, Open-label, Randomized Study to Compare the Safety and Efficacy of Once Daily Levofloxacin Along With Once Daily Metronidazole Versus Piperacillin/Tazobactam in the Treatment of Complicated Appendicitis
The purpose of this study is to compare the efficacy and safety of two treatment regimens in treating patients with complicated appendicitis. Appendicitis requires antibiotic treatment when the appendix ruptures (complicated appendicitis). This is a study comparing intravenous (IV) antibiotic therapy of levofloxacin/metronidazole versus piperacillin/tazobactam for 4 to 14 days. Patients may be switched to oral therapy after 48 hours, at the doctor's discretion.
Read the detailed description
Appendicitis may be classified as uncomplicated (the appendix has not ruptured) or complicated (the appendix has ruptured or gangrene has begun). Typically all patients with complicated appendicitis are treated with intravenous (IV, through a vein) antibiotic therapy. This is a multicenter, open-label, randomized study of patients who have complicated appendicitis. Prior to surgery, patients will be randomized to either the levofloxacin/metronidazole IV group (given once daily) or the piperacillin/tazobactam IV group (given 4 times daily) and will be started on study drug. Patients who are confirmed during surgery to have complicated appendicitis, will continue to receive study drug to complete a total of 4-14 days of therapy. Those found to have uncomplicated appendicitis will stop taking study drug and be discontinued from the study. Patients may be switched after 48 hours to oral therapy, at the doctor's discretion. Patients randomized to levofloxacin/metronidazole will be switched to oral levofloxacin/metronidazole given once daily. Patients randomized to piperacillin/tazobactam will be switched to oral amoxicillin/clavulanate acid given twice daily. While in the hospital, daily assessments will be made of the patient for clinical signs and symptoms of post-operative wound infection. In addition, temperature, vital signs, pertinent physical findings, white blood count (until normal), and tests for infection will be assessed daily while in the hospital. Wound assessments and laboratory tests will be performed on the last visit as an outpatient. The main objective of this study is to determine the safety and effectiveness of the regimen containing levofloxacin and metronidazole compared with the regimen of piperacillin/tazobactam in the treatment of complicated appendicitis.
Levofloxacin 750 mg IV (through a vein) or orally then metronidazole 1500 milligrams IV (or tablet form by mouth) once daily for 4 to 14 days; or piperacillin/tazobactam 3.375 grams IV every 6 hours (or amoxicillin/clavulanate acid 875/125 milligram tablets by mouth every 12 hours) for 4 to 14 days
- Conditions
- Appendicitis
- Being tested
- levofloxacin; metronidazole
- Keywords
- complicated appendicitis, antibiotics, appendicitis, infection
- Medical subject headings
- Appendicitis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levofloxacin; metronidazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success at the post-therapy visit; safety by adverse events.
Secondary outcomes (1)
Clinical and microbiologic response at post-therapy and post-study; costs associated with care.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startJul 2003
- Study completionSep 2004
Why it stopped: This study was terminated due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc.
- Investigators
- Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236912
- Sponsor's protocol ID
- CR002656
- Status last verified
- Apr 2010
- First submitted
- 7 Oct 2005
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Randomized Study to Compare the Safety and Efficacy of Once Daily Levofloxacin Along With Once Daily Metronidazole Versus Piperacillin/Tazobactam in the Treatment of Complicated Appendicitis
- ClinicalTrials.gov ID
- NCT00236912
- Acronym / sponsor ID
- CR002656
- Conditions
- Appendicitis
- Keywords
- complicated appendicitis, antibiotics, appendicitis, infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated due to low enrollment.
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc.
- Study start
- Jul 2003
- Study completion
- Sep 2004 (actual)
- First posted
- 12 Oct 2005 (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 purpose of this study is to compare the efficacy and safety of two treatment regimens in treating patients with complicated appendicitis. Appendicitis requires antibiotic treatment when the appendix ruptures (complicated appendicitis). This is a study comparing intravenous (IV) antibiotic therapy of levofloxacin/metronidazole versus piperacillin/tazobactam for 4 to 14 days. Patients may be switched to oral therapy after 48 hours, at the doctor's discretion.
Detailed description
Appendicitis may be classified as uncomplicated (the appendix has not ruptured) or complicated (the appendix has ruptured or gangrene has begun). Typically all patients with complicated appendicitis are treated with intravenous (IV, through a vein) antibiotic therapy. This is a multicenter, open-label, randomized study of patients who have complicated appendicitis. Prior to surgery, patients will be randomized to either the levofloxacin/metronidazole IV group (given once daily) or the piperacillin/tazobactam IV group (given 4 times daily) and will be started on study drug. Patients who are confirmed during surgery to have complicated appendicitis, will continue to receive study drug to complete a total of 4-14 days of therapy. Those found to have uncomplicated appendicitis will stop taking study drug and be discontinued from the study. Patients may be switched after 48 hours to oral therapy, at the doctor's discretion. Patients randomized to levofloxacin/metronidazole will be switched to oral levofloxacin/metronidazole given once daily. Patients randomized to piperacillin/tazobactam will be switched to oral amoxicillin/clavulanate acid given twice daily. While in the hospital, daily assessments will be made of the patient for clinical signs and symptoms of post-operative wound infection. In addition, temperature, vital signs, pertinent physical findings, white blood count (until normal), and tests for infection will be assessed daily while in the hospital. Wound assessments and laboratory tests will be performed on the last visit as an outpatient. The main objective of this study is to determine the safety and effectiveness of the regimen containing levofloxacin and metronidazole compared with the regimen of piperacillin/tazobactam in the treatment of complicated appendicitis.
Levofloxacin 750 mg IV (through a vein) or orally then metronidazole 1500 milligrams IV (or tablet form by mouth) once daily for 4 to 14 days; or piperacillin/tazobactam 3.375 grams IV every 6 hours (or amoxicillin/clavulanate acid 875/125 milligram tablets by mouth every 12 hours) for 4 to 14 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Two or more symptoms of acute appendicitis for at least 24 hours or radiologic evidence of complicated appendicitis
- Able to take medicine orally after recovering from surgery
- If female, using birth control
Key exclusion criteria (8 listed)
- History of allergy to any study medication
- Life expectancy < 72 hours
- APACHE II (health) score > 25
- Neutropenic (low white blood cell count)
- HIV positive with current or past CD4 count < 200/mm^3
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 |
|---|---|---|
| levofloxacin; metronidazole | Drug | – |
Primary outcome
Clinical success at the post-therapy visit; safety by adverse events.
1 secondary outcome
Clinical and microbiologic response at post-therapy and post-study; costs associated with care.
Results and safety
The study was stopped early (reason given: This study was terminated due to low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
- A Multicenter, Open-Label, Randomized Study to Compare the Safety and Efficacy of Once Daily Levofloxacin Along With Once Daily Metronidazole Versus Piperacillin/Tazobactam in the Treatment of Complicated AppendicitisLink provided by the sponsor.
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
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.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levofloxacin; metronidazole in people with Appendicitis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: This study was terminated due to low enrollment.). Results are not available in the source record.
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?
Clinical success at the post-therapy visit; safety by adverse events.. 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 Jun 2011.