Foot Infections in Diabetic PatientsPhase 3NCT00229112
Comparative Study of Ertapenem Versus Another Antibiotic in the Treatment of Diabetic Foot Infections in Adults (0826-034)
A Phase 3 study testing MK0826, ertapenem sodium / Duration of Treatment - 24 weeks and Comparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeks in people with Foot Infections in Diabetic Patients, run by Merck Sharp & Dohme LLC.
Trial summary
This study will compare the efficacy, safety and tolerability of intravenous ertapenem versus another intravenous antibiotic in the treatment of moderate to severe diabetic foot infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Infections in Diabetic Patients
- What is being tested?
- MK0826, ertapenem sodium / Duration of Treatment - 24 weeks and Comparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeks
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Apr 2001to Apr 2004
- 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
- Type 1 or 2 Diabetes Mellitus treated with diet or medication
- Clinically or microbiologically documented foot infection below the knee
- Osteomyelitic bone must be removed within 48 hours of study entry
Who cannot join
- Uncomplicated skin infections
- Infected burn wounds
- Necrotizing fascitis
- Wounds with gangrene that cannot be removed with debridement
- Infections of prosthetic materials
- Foreign materials that can not be removed by surgical debridement
- Patients with another antibiotic 3 days prior to enrollment without evidence of treatment failure and presence of a positive culture
- Insufficient blood flow to the limb requiring a revascularization procedure
About this study
Official title: A Prospective, Multicenter, Double-Blind With In-House Blinding, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability, of Ertapenem Versus Piperacillin/Tazobactam in the Treatment of Diabetic Foot Infections in Adults.
This study will compare the efficacy, safety and tolerability of intravenous ertapenem versus another intravenous antibiotic in the treatment of moderate to severe diabetic foot infections.
- Conditions
- Foot Infections in Diabetic Patients
- Being tested
- MK0826, ertapenem sodium / Duration of Treatment - 24 weeks, Comparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0826, ertapenem sodium / Duration of Treatment - 24 weeksDrug
Comparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure/Improvement at discontinuation of IV antibiotic therapy.
Secondary outcomes (1)
Clinical Cure: 1. Day 5 of IV antibiotic therapy; 2.10 days after completion of all antibiotic therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startApr 2001
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Foot Infections in Diabetic PatientsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 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
- NCT00229112
- Sponsor's protocol ID
- 0826-034
- Other IDs
- 2005_083
- Status last verified
- Feb 2017
- First submitted
- 27 Sep 2005
- Last updated
- 17 Feb 2017
- Results posted
- No
Publications
Citron DM, Goldstein EJ, Merriam CV, Lipsky BA, Abramson MA. Bacteriology of moderate-to-severe diabetic foot infections and in vitro activity of antimicrobial agents. J Clin Microbiol. 2007 Sep;45(9):2819-28. doi: 10.1128/JCM.00551-07. Epub 2007 Jul 3.
PubMed 17609322Armstrong DG, Lipsky BA, Polis AB, Abramson MA. Does dermal thermometry predict clinical outcome in diabetic foot infection? Analysis of data from the SIDESTEP* trial. Int Wound J. 2006 Dec;3(4):302-7. doi: 10.1111/j.1742-481X.2006.00269.x.
PubMed 17199766Lipsky BA, Sheehan P, Armstrong DG, Tice AD, Polis AB, Abramson MA. Clinical predictors of treatment failure for diabetic foot infections: data from a prospective trial. Int Wound J. 2007 Mar;4(1):30-8. doi: 10.1111/j.1742-481X.2006.00274.x.
PubMed 17425547Lipsky BA, Polis AB, Lantz KC, Norquist JM, Abramson MA. The value of a wound score for diabetic foot infections in predicting treatment outcome: a prospective analysis from the SIDESTEP trial. Wound Repair Regen. 2009 Sep-Oct;17(5):671-7. doi: 10.1111/j.1524-475X.2009.00521.x. Epub 2009 Aug 11.
PubMed 19671126Lipsky BA, Armstrong DG, Citron DM, Tice AD, Morgenstern DE, Abramson MA. Ertapenem versus piperacillin/tazobactam for diabetic foot infections (SIDESTEP): prospective, randomised, controlled, double-blinded, multicentre trial. Lancet. 2005 Nov 12;366(9498):1695-703. doi: 10.1016/S0140-6736(05)67694-5.
PubMed 16291062
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Double-Blind With In-House Blinding, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability, of Ertapenem Versus Piperacillin/Tazobactam in the Treatment of Diabetic Foot Infections in Adults.
- ClinicalTrials.gov ID
- NCT00229112
- Acronym / sponsor ID
- 0826-034
- Conditions
- Foot Infections in Diabetic Patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 29 Sep 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.
This study will compare the efficacy, safety and tolerability of intravenous ertapenem versus another intravenous antibiotic in the treatment of moderate to severe diabetic foot infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 1 or 2 Diabetes Mellitus treated with diet or medication
- Clinically or microbiologically documented foot infection below the knee
- Osteomyelitic bone must be removed within 48 hours of study entry
Key exclusion criteria (8 listed)
- Uncomplicated skin infections
- Infected burn wounds
- Necrotizing fascitis
- Wounds with gangrene that cannot be removed with debridement
- Infections of prosthetic materials
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 |
|---|---|---|
| MK0826, ertapenem sodium / Duration of Treatment - 24 weeks | Drug | – |
| Comparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeks | Drug | – |
Primary outcome
Clinical Cure/Improvement at discontinuation of IV antibiotic therapy.
1 secondary outcome
Clinical Cure: 1. Day 5 of IV antibiotic therapy; 2.10 days after completion of all antibiotic therapy.
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 17 Feb 2017.
- Background: PubMed 17609322Citron DM, Goldstein EJ, Merriam CV, Lipsky BA, Abramson MA. Bacteriology of moderate-to-severe diabetic foot infections and in vitro activity of antimicrobial agents. J Clin Microbiol. 2007 Sep;45(9):2819-28. doi: 10.1128/JCM.00551-07. Epub 2007 Jul 3.
- Background: PubMed 17199766Armstrong DG, Lipsky BA, Polis AB, Abramson MA. Does dermal thermometry predict clinical outcome in diabetic foot infection? Analysis of data from the SIDESTEP* trial. Int Wound J. 2006 Dec;3(4):302-7. doi: 10.1111/j.1742-481X.2006.00269.x.
- Background: PubMed 17425547Lipsky BA, Sheehan P, Armstrong DG, Tice AD, Polis AB, Abramson MA. Clinical predictors of treatment failure for diabetic foot infections: data from a prospective trial. Int Wound J. 2007 Mar;4(1):30-8. doi: 10.1111/j.1742-481X.2006.00274.x.
- Background: PubMed 19671126Lipsky BA, Polis AB, Lantz KC, Norquist JM, Abramson MA. The value of a wound score for diabetic foot infections in predicting treatment outcome: a prospective analysis from the SIDESTEP trial. Wound Repair Regen. 2009 Sep-Oct;17(5):671-7. doi: 10.1111/j.1524-475X.2009.00521.x. Epub 2009 Aug 11.
- Results publication: PubMed 16291062Lipsky BA, Armstrong DG, Citron DM, Tice AD, Morgenstern DE, Abramson MA. Ertapenem versus piperacillin/tazobactam for diabetic foot infections (SIDESTEP): prospective, randomised, controlled, double-blinded, multicentre trial. Lancet. 2005 Nov 12;366(9498):1695-703. doi: 10.1016/S0140-6736(05)67694-5.
Related trials for Foot Infections in Diabetic Patients
Active, not recruiting
Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer
Diabetic Foot Ulcer, Diabetic Foot Infection
RecruitingObservational study
New Diagnostic Tool (MinION) for Identifying Microorganisms in Foot Wounds of Patients Living With Diabetic Foot Osteomyelitis
Diabetes Mellitus, Diabetes Complications
Not yet recruitingPhase 2/3
Clinical Study in Adult Patients With Purulent-inflammatory Processes of the Skin and Soft Tissues, Phase I-II of the Wound Process
Diabetic Foot Infections, Chronic Venous Insufficiency
Active, not recruitingPhase 2
Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic Foot Ulcers
Diabetic Foot Ulcers
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 MK0826, ertapenem sodium / Duration of Treatment - 24 weeks and Comparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeks in people with Foot Infections in Diabetic Patients, 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 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: finished, as of the sponsor's last update on 17 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?
Clinical Cure/Improvement at discontinuation of IV antibiotic therapy.. 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 NCT00229112, which also lists 5 linked publications.
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 17 Feb 2017.