Skin InfectionPhase 3NCT00619710
Complicated Skin and Skin Structure Infections
A Phase 3 study testing Meropenem and Imipenem-cilastatin in people with Skin Infection and Abscess, run by Pfizer.
Trial summary
The purpose of this study is to demonstrate the non-inferiority of meropenem (Merrem) and imipenem in hospitalised subjects with complicated skin and skin structure infections. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Skin Infection, Abscess, Cellulitis
- What is being tested?
- Meropenem and Imipenem-cilastatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Feb 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects are hospitalized males and females, aged 13 years or older, with clinical evidence of complicated skin and skin structure bacterial infection with material suitable for culture from 1 primary site of infections
- Within 72 hours before enrollment or at the time of enrollment, all subjects must provide an appropriate specimen for culture and susceptibility testing
- Subjects who have been given prior antibacterial therapy within 14 days of trial entry may be entered only if a culture is obtained showing persistence of a pathogen in blood or at the site of infection
Who cannot join
- Subjects with a known or suspected hypersensitivity to cephalosporins, penicillins, or carbapenems
- Subjects with a history of seizure disorders or subjects currently receiving antiepileptic medication
- Subjects with underlying infections or conditions which would interfere with evaluation of this study
About this study
Official title: A Multicenter, Randomized, Double Blind, Comparative Trial of Intravenous MERREM (Meropenem, ICI 194,660) vs PRIMAXIN I.V. (Imipenem-cilastatin) in the Treatment of Hospitalised Subjects With Complicated Skin and Skin Structure Infections.
The purpose of this study is to demonstrate the non-inferiority of meropenem (Merrem) and imipenem in hospitalised subjects with complicated skin and skin structure infections.
- Conditions
- Skin Infection, Abscess, Cellulitis
- Being tested
- Meropenem, Imipenem-cilastatin
- Keywords
- skin infections, MERREM, PRIMAXIN IV, complex abscess, perirectal abscess, wound infections, infected ischemic/diabetic ulcers, cellulitis, Meropenem, Imipenem-cilastatin
- Medical subject headings
- Cellulitis, Abscess, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeropenemDrug
Also called Merrem
Intravenous
Imipenem-cilastatinDrug
Also called Primaxin
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Meropenem Receives: Drug: Meropenem |
| 2 | Active comparator | Imipenem-cilastatin Receives: Drug: Imipenem-cilastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary measure is clinical response after all antibacterial treatment is stopped).
Measured: 7-28 days
Secondary outcomes (1)
clinical and microbiological response
Measured: Twice 3-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startFeb 2001
- Primary completionDec 2003
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin InfectionStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619710
- Sponsor's protocol ID
- 3591IL/0079
- Other IDs
- D9211C00079
- Status last verified
- Aug 2017
- First submitted
- 6 Feb 2008
- Last updated
- 1 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Comparative Trial of Intravenous MERREM (Meropenem, ICI 194,660) vs PRIMAXIN I.V. (Imipenem-cilastatin) in the Treatment of Hospitalised Subjects With Complicated Skin and Skin Structure Infections.
- ClinicalTrials.gov ID
- NCT00619710
- Acronym / sponsor ID
- 3591IL/0079
- Conditions
- Skin Infection, Abscess, Cellulitis
- Keywords
- skin infections, MERREM, PRIMAXIN IV, complex abscess, perirectal abscess, wound infections, infected ischemic/diabetic ulcers, cellulitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Dec 2003 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 21 Feb 2008 (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 demonstrate the non-inferiority of meropenem (Merrem) and imipenem in hospitalised subjects with complicated skin and skin structure infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MeropenemMeropenem |
| 2 | Active comparator | Drug: Imipenem-cilastatinImipenem-cilastatin |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects are hospitalized males and females, aged 13 years or older, with clinical evidence of complicated skin and skin structure bacterial infection with material suitable for culture from 1 primary site of infections
- Within 72 hours before enrollment or at the time of enrollment, all subjects must provide an appropriate specimen for culture and susceptibility testing
- Subjects who have been given prior antibacterial therapy within 14 days of trial entry may be entered only if a culture is obtained showing persistence of a pathogen in blood or at the site of infection
Key exclusion criteria (3 listed)
- Subjects with a known or suspected hypersensitivity to cephalosporins, penicillins, or carbapenems
- Subjects with a history of seizure disorders or subjects currently receiving antiepileptic medication
- Subjects with underlying infections or conditions which would interfere with evaluation of this study
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 |
|---|---|---|
| MeropenemAlso: MerremIntravenous | Drug | 1 |
| Imipenem-cilastatinAlso: PrimaxinIntravenous | Drug | 2 |
Primary outcome
The primary measure is clinical response after all antibacterial treatment is stopped).
Time frame: 7-28 days
1 secondary outcome
clinical and microbiological response
Time frame: Twice 3-28 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 1 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meropenem and Imipenem-cilastatin in people with Skin Infection and Abscess, run by Pfizer.
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 3 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 1 Sep 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?
The primary measure is clinical response after all antibacterial treatment is stopped). (time frame: 7-28 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 1 Sep 2017.