InfectionPhase 3NCT00398099
To Evaluate the Treatment Effect of an Anti-Infective Agent for Different Kinds of Infections (0826-052)
A Phase 3 study testing MK0826, ertapenem sodium / Duration of Treatment: 14 Days in people with Infection and Pneumonia, run by Merck Sharp & Dohme LLC.
Trial summary
To collect clinical response data with the use of ertapenem in approved indications. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Infection, Pneumonia, Urinary Tract Infection
- What is being tested?
- MK0826, ertapenem sodium / Duration of Treatment: 14 Days
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Jan 2006
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, 20 years of age or older
- Patients did not receive any systemic antibiotic before enrollment, or patients with failed clinical response (no improvement on symptoms or laboratory data) through previous antibiotic treatment
- Patients who required therapy prior to identification of cause of infection
Who cannot join
- Patient has a concomitant infection that may interfere with the evaluation of the response to ertapenem
- Patient has an apache ii > 30.
- Patient has an infection caused by pathogens resistant to ertapenem
- Patients with known allergy to ertapenem or other drugs in the same carbapenem class, beta - lactams, lidocaine or local anesthetics of the amide type
- The patient requires antibiotics other than ertapenem (such as: glycopeptides, macrolides or antifungal agents)
About this study
Official title: Clinical Evaluation for the Efficacy, Safety, Tolerability & Medical Resource Utilization of Invanz (Ertapenem Sodium) Therapy
To collect clinical response data with the use of ertapenem in approved indications.
- Conditions
- Infection, Pneumonia, Urinary Tract Infection
- Being tested
- MK0826, ertapenem sodium / Duration of Treatment: 14 Days
- Medical subject headings
- Infections, Pneumonia, Urinary Tract Infections
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: 14 DaysDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment
Secondary outcomes (1)
Safety and Tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startJul 2005
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT00398099
- Sponsor's protocol ID
- 0826-052
- Other IDs
- 2006_046
- Status last verified
- Feb 2017
- First submitted
- 9 Nov 2006
- Last updated
- 17 Feb 2017
- Results posted
- No
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
- Clinical Evaluation for the Efficacy, Safety, Tolerability & Medical Resource Utilization of Invanz (Ertapenem Sodium) Therapy
- ClinicalTrials.gov ID
- NCT00398099
- Acronym / sponsor ID
- 0826-052
- Conditions
- Infection, Pneumonia, Urinary Tract Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 10 Nov 2006 (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.
To collect clinical response data with the use of ertapenem in approved indications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients, 20 years of age or older
- Patients did not receive any systemic antibiotic before enrollment, or patients with failed clinical response (no improvement on symptoms or laboratory data) through previous antibiotic treatment
- Patients who required therapy prior to identification of cause of infection
Key exclusion criteria (5 listed)
- Patient has a concomitant infection that may interfere with the evaluation of the response to ertapenem
- Patient has an apache ii > 30.
- Patient has an infection caused by pathogens resistant to ertapenem
- Patients with known allergy to ertapenem or other drugs in the same carbapenem class, beta - lactams, lidocaine or local anesthetics of the amide type
- The patient requires antibiotics other than ertapenem (such as: glycopeptides, macrolides or antifungal agents)
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: 14 Days | Drug | – |
Primary outcome
Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment
1 secondary outcome
Safety and Tolerability
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.
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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 MK0826, ertapenem sodium / Duration of Treatment: 14 Days in people with Infection and Pneumonia, 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 5 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?
Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment. 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 17 Feb 2017.