Complicated Skin and Skin Structure InfectionPhase 3NCT00299520
Phase 3 Safety and Efficacy Study of I.V. Iclaprim v Linezolid in cSSSI (ASSIST-1)
A Phase 3 study testing intravenous iclaprim or intravenous linezolid in people with Complicated Skin and Skin Structure Infection, run by Arpida AG at 5 sites in United States.
Trial summary
This is a multi-center, investigator-blind, comparative Phase 3 study. Patients will receive either iclaprim or linezolid for 10 to 14 days. Patients will be evaluated daily for the first four days of study treatment and then every other day, for up to 14 days of the treatment period, at End of Therapy, the Test Of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complicated Skin and Skin Structure Infection
- What is being tested?
- intravenous iclaprim or intravenous linezolid
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- Jun 2005to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria -Diagnosis of an infection consistent with complicated skin and skin structure infection due to a gram positive pathogen.
Exclusion Criteria: - Known or suspected hypersensitivity to any study medication or other related anti-infective medication - Any known or suspected condition or concurrent treatment contraindicated by the prescribing information - Previous enrollment in this study - Treatment with any investigational drug within 30 days before enrollment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
VA Medical Center
Boise, Idaho, 83702
Judith Stone. M.D.
Cumberland, Maryland, 21502
Infectious Disease of Indiana
Indianapolis, Indiana, 46260
e-Study Site
National City, California, 91950
ID Clinical Research, Ltd.
Toledo, Ohio, 43608
About this study
Official title: Phase 3, Randomized, Investigator-Blind, Multi-Center Study to Evaluate Efficacy and Safety of Intravenous Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections.(ASSIST-1)
This is a multi-center, investigator-blind, comparative Phase 3 study. Patients will receive either iclaprim or linezolid for 10 to 14 days. Patients will be evaluated daily for the first four days of study treatment and then every other day, for up to 14 days of the treatment period, at End of Therapy, the Test Of Cure visit (7 to 14 days post treatment), and a Late Follow-up (F/U) visit (7 to 14 days after the TOC visit).
Read the detailed description
Primary Objective:
The primary objective of this study is to compare the clinical cure rates of iclaprim and linezolid at the test of cure (TOC) visit (7 to 14 days after the end of treatment).
Secondary Objectives:
The secondary objectives of this study are to compare iclaprim with linezolid regarding:
- Clinical efficacy at the end of study medication treatment;
- Time to resolution of systemic and local signs and symptoms of complicated skin and skin structure infection (cSSSI);
- Clinical outcome in the microbiologically evaluable (ME) population;
- Bacteriologic outcome in the ME population;
- Bacteriologic eradication rates of Baseline (BL) pathogens;
- Clinical outcome in the modified intent-to-treat (MITT) population;
- Bacteriologic outcome in the MITT population;
- Baseline in vitro susceptibility of isolated pathogens in the ME population; and
- Safety and tolerability of iclaprim treatment.
- Being tested
- intravenous iclaprim or intravenous linezolid
- Keywords
- skin infection, complicated skin infection, skin structure infection
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous iclaprim or intravenous linezolidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate (the ratio of number of clinically cured patients to the total number of patients in the population) at 7 to 14 days after the end of therapy
Secondary outcomes (2)
Microbiological eradication rate at 7-14 days after end of therapy.
Safety evaluations conducted during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2006 (estimated)
- Study startJun 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Skin and Skin Structure InfectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Arpida AG
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299520
- Sponsor's protocol ID
- Protocol No. ICLA-08-CSI1
- Other IDs
- ASSIST-1
- Status last verified
- Apr 2008
- First submitted
- 3 Mar 2006
- Last updated
- 4 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Randomized, Investigator-Blind, Multi-Center Study to Evaluate Efficacy and Safety of Intravenous Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections.(ASSIST-1)
- ClinicalTrials.gov ID
- NCT00299520
- Acronym / sponsor ID
- Protocol No. ICLA-08-CSI1
- Keywords
- skin infection, complicated skin infection, skin structure infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Arpida AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Study completion
- Jul 2006
- First posted
- 7 Mar 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.
This is a multi-center, investigator-blind, comparative Phase 3 study. Patients will receive either iclaprim or linezolid for 10 to 14 days. Patients will be evaluated daily for the first four days of study treatment and then every other day, for up to 14 days of the treatment period, at End of Therapy, the Test Of Cure visit (7 to 14 days post treatment), and a Late Follow-up (F/U) visit (7 to 14 days after the TOC visit).
Detailed description
Primary Objective:
The primary objective of this study is to compare the clinical cure rates of iclaprim and linezolid at the test of cure (TOC) visit (7 to 14 days after the end of treatment).
Secondary Objectives:
The secondary objectives of this study are to compare iclaprim with linezolid regarding:
- Clinical efficacy at the end of study medication treatment;
- Time to resolution of systemic and local signs and symptoms of complicated skin and skin structure infection (cSSSI);
- Clinical outcome in the microbiologically evaluable (ME) population;
- Bacteriologic outcome in the ME population;
- Bacteriologic eradication rates of Baseline (BL) pathogens;
- Clinical outcome in the modified intent-to-treat (MITT) population;
- Bacteriologic outcome in the MITT population;
- Baseline in vitro susceptibility of isolated pathogens in the ME population; and
- Safety and tolerability of iclaprim treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| intravenous iclaprim or intravenous linezolid | Drug | – |
Primary outcome
Clinical cure rate (the ratio of number of clinically cured patients to the total number of patients in the population) at 7 to 14 days after the end of therapy
2 secondary outcomes
Microbiological eradication rate at 7-14 days after end of therapy.
Safety evaluations conducted during the study
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 4 Apr 2008.
- ARPIDA AG corporate websiteLink provided by the sponsor.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intravenous iclaprim or intravenous linezolid in people with Complicated Skin and Skin Structure Infection, run by Arpida AG at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 rate (the ratio of number of clinically cured patients to the total number of patients in the population) at 7 to 14 days after the end of therapy. 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 4 Apr 2008.