Intra-abdominal InfectionPhase 3NCT00481702
A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)
A Phase 3 study testing Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks, MK0826, /Duration of Treatment : 8 Weeks and Comparator: metronidazole / Duration of Treatment: 8 Weeks in people with Intra-abdominal Infection, run by Merck Sharp & Dohme LLC.
Trial summary
A multicenter study to evaluate the effectiveness of ertapenem compared to ceftriaxone/metronidazole in treating certain abdominal infections that require surgery in adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-abdominal Infection
- What is being tested?
- Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks, MK0826, /Duration of Treatment : 8 Weeks and Comparator: metronidazole / Duration of Treatment: 8 Weeks
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Dec 2001to Jun 2003
- Phase
- Phase 3
- 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
- Male or female patients age 18 or older
- Patient has a diagnosis of intra-abdominal infection requiring surgery as evidenced by fever, elevated while blood cell count and abdominal pain
Who cannot join
- Patient has another infection, other than abdominal
- Female patient is pregnant or planning to become pregnant
About this study
Official title: A Prospective, Multicenter, Open-Label, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-Abdominal Infections in Adults
A multicenter study to evaluate the effectiveness of ertapenem compared to ceftriaxone/metronidazole in treating certain abdominal infections that require surgery in adult patients.
- Conditions
- Intra-abdominal Infection
- Being tested
- Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks, MK0826, /Duration of Treatment : 8 Weeks, Comparator: metronidazole / Duration of Treatment: 8 Weeks
- Medical subject headings
- Intraabdominal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: ceftriaxone sodium / Duration of Treatment: 8 WeeksDrug
MK0826, /Duration of Treatment : 8 WeeksDrug
Comparator: metronidazole / Duration of Treatment: 8 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection
Measured: 2 weeks after treatment
Secondary outcomes (1)
That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection
Measured: 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study startDec 2001
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intra-abdominal InfectionStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481702
- Sponsor's protocol ID
- 0826-802
- Other IDs
- 2007_558
- Status last verified
- Feb 2017
- First submitted
- 1 Jun 2007
- Last updated
- 20 Feb 2017
- Results posted
- No
Publications
Navarro NS Jr, Campos MI, Alvarado R, Quintero N, Branicki FJ, Wei J, Shivaprakash M, Vrijens F, Giezek H, Chan CY, DiNubile MJ; Oasis II Study Team. Ertapenem versus ceftriaxone and metronidazole as treatment for complicated intra-abdominal infections. Int J Surg. 2005;3(1):25-34. doi: 10.1016/j.ijsu.2005.03.010.
PubMed 17462256
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Open-Label, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-Abdominal Infections in Adults
- ClinicalTrials.gov ID
- NCT00481702
- Acronym / sponsor ID
- 0826-802
- Conditions
- Intra-abdominal Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 4 Jun 2007 (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.
A multicenter study to evaluate the effectiveness of ertapenem compared to ceftriaxone/metronidazole in treating certain abdominal infections that require surgery in adult patients.
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 (2 listed)
- Male or female patients age 18 or older
- Patient has a diagnosis of intra-abdominal infection requiring surgery as evidenced by fever, elevated while blood cell count and abdominal pain
Key exclusion criteria (2 listed)
- Patient has another infection, other than abdominal
- Female patient is pregnant or planning to become pregnant
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 |
|---|---|---|
| Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks | Drug | – |
| MK0826, /Duration of Treatment : 8 Weeks | Drug | – |
| Comparator: metronidazole / Duration of Treatment: 8 Weeks | Drug | – |
Primary outcome
That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection
Time frame: 2 weeks after treatment
1 secondary outcome
That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection
Time frame: 4 weeks after treatment
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 20 Feb 2017.
- Background: PubMed 17462256Navarro NS Jr, Campos MI, Alvarado R, Quintero N, Branicki FJ, Wei J, Shivaprakash M, Vrijens F, Giezek H, Chan CY, DiNubile MJ; Oasis II Study Team. Ertapenem versus ceftriaxone and metronidazole as treatment for complicated intra-abdominal infections. Int J Surg. 2005;3(1):25-34. doi: 10.1016/j.ijsu.2005.03.010.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks, MK0826, /Duration of Treatment : 8 Weeks and Comparator: metronidazole / Duration of Treatment: 8 Weeks in people with Intra-abdominal Infection, run by Merck Sharp & Dohme LLC.
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 2 inclusion and 2 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 20 Feb 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection (time frame: 2 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00481702, which also lists 1 linked publication.
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 20 Feb 2017.