Infection ProphylaxisPhase 2NCT01389700
Pharmacokinetics, Pharmacodynamics and Safety Evaluation of SAR279356 in Intensive Care Unit Mechanically Ventilated Patients
A Phase 2 study testing SAR279356 in people with Infection Prophylaxis, run by Sanofi at 6 sites in United States.
Trial summary
Primary Objective: To determine the pharmacokinetics (PK) of a single intravenous (IV) dose of SAR279356 administered to intensive care unit (ICU) patients on mechanical ventilation Secondary Objectives: To determine the safety and tolerability of SAR279356 To evaluate the pharmacodynamics (PD) and immunogenicity of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection Prophylaxis
- What is being tested?
- SAR279356
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2011to Dec 2012
- Phase
- Phase 2
- 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
- ICU patients on mechanical ventilation at the time of randomization
- Patients or legally authorized representative (LAR) giving written informed consent.
Who cannot join
- Patients <18 years of age;
- Documented Pseudomonas infection or colonization in the last 30 days;
- Immunocompromised patients
- Hypersensitivity to the study drug and/or to prior therapy with monoclonal antibodies;
- Patient who has taken other investigational drugs or prohibited therapy for this study within 1 month or 5 half-lives, whichever is longer;
- Patient or LAR who withdraws consent during the screening (starting from signed informed consent form);
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- Acute liver injury related criteria at the time of study entry:
- Pregnant or breast-feeding women
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Investigational Site Number 840009
Butte, Montana, 59701
Investigational Site Number 840003
Camden, New Jersey, 08103
Investigational Site Number 840006
Jacksonville, Florida, 32209
Investigational Site Number 840010
Los Angeles, California, 90024
Investigational Site Number 840001
Pikeville, Kentucky, 41501
Investigational Site Number 840020
Stanford, California, 94305
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of SAR279356 in Patients Hospitalized in Intensive Care Unit and on Mechanical Ventilation
Primary Objective:
- To determine the pharmacokinetics (PK) of a single intravenous (IV) dose of SAR279356 administered to intensive care unit (ICU) patients on mechanical ventilation
Secondary Objectives:
- To determine the safety and tolerability of SAR279356
- To evaluate the pharmacodynamics (PD) and immunogenicity of SAR279356
- Exploratory efficacy of SAR279356 on prevention of bacterial infections
Read the detailed description
Total study duration (from screening to last follow-up visit) is 91 days break down as follows:
- Screening: 1 day prior to dosing;
- Treatment period: one IV injection on Day 1;
- Follow-up period: 90 days
- Conditions
- Infection Prophylaxis
- Being tested
- SAR279356, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR279356Drug
Pharmaceutical form: solution for infusion
Route of administration: intravenous infusion
placeboDrug
Pharmaceutical form: solution for infusion
Route of administration: intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| SAR279356 dose 1 | Experimental | SAR279356 dose 1, single administration Receives: Drug: SAR279356 |
| SAR279356 dose 2 | Experimental | SAR279356 dose 2, single administration Receives: Drug: SAR279356 |
| Placebo | Placebo comparator | Matching placebo, single administration Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameters of SAR279356 : Ceoi, AUClast and CL
Measured: 90 days
Secondary outcomes (4)
Opsonophagocytic assay (OPA)
Measured: 90 days
Opsonophagocytic killing assay (OPK)
Measured: 90 days
Dosage of human anti-human antibodies (HAHA)
Measured: 90 days
Occurrence of infections
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Difficulty in patient recruitment in the participating sites
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection ProphylaxisStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389700
- Sponsor's protocol ID
- PKD11791
- Other IDs
- U1111-1118-6717
- Status last verified
- Nov 2014
- First submitted
- 6 Jul 2011
- Last updated
- 12 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of SAR279356 in Patients Hospitalized in Intensive Care Unit and on Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01389700
- Acronym / sponsor ID
- PKD11791
- Conditions
- Infection Prophylaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in patient recruitment in the participating sites
- Enrolment
- 7 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Jul 2011 (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.
Primary Objective:
- To determine the pharmacokinetics (PK) of a single intravenous (IV) dose of SAR279356 administered to intensive care unit (ICU) patients on mechanical ventilation
Secondary Objectives:
- To determine the safety and tolerability of SAR279356
- To evaluate the pharmacodynamics (PD) and immunogenicity of SAR279356
- Exploratory efficacy of SAR279356 on prevention of bacterial infections
Detailed description
Total study duration (from screening to last follow-up visit) is 91 days break down as follows:
- Screening: 1 day prior to dosing;
- Treatment period: one IV injection on Day 1;
- Follow-up period: 90 days
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SAR279356 dose 1 | Experimental | Drug: SAR279356SAR279356 dose 1, single administration |
| SAR279356 dose 2 | Experimental | Drug: SAR279356SAR279356 dose 2, single administration |
| Placebo | Placebo comparator | Drug: placeboMatching placebo, single administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ICU patients on mechanical ventilation at the time of randomization
- Patients or legally authorized representative (LAR) giving written informed consent.
Key exclusion criteria (9 listed)
- Patients <18 years of age;
- Documented Pseudomonas infection or colonization in the last 30 days;
- Immunocompromised patients
- Hypersensitivity to the study drug and/or to prior therapy with monoclonal antibodies;
- Patient who has taken other investigational drugs or prohibited therapy for this study within 1 month or 5 half-lives, whichever is longer;
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 |
|---|---|---|
| SAR279356Pharmaceutical form: solution for infusion Route of administration: intravenous infusion | Drug | SAR279356 dose 1, SAR279356 dose 2 |
| placeboPharmaceutical form: solution for infusion Route of administration: intravenous infusion | Drug | Placebo |
Primary outcome
Pharmacokinetics parameters of SAR279356 : Ceoi, AUClast and CL
Time frame: 90 days
4 secondary outcomes
Opsonophagocytic assay (OPA)
Time frame: 90 days
Opsonophagocytic killing assay (OPK)
Time frame: 90 days
Dosage of human anti-human antibodies (HAHA)
Time frame: 90 days
Occurrence of infections
Time frame: Up to 28 days
Results and safety
The study was stopped early (reason given: Difficulty in patient recruitment in the participating sites). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
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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.
Clinical Sciences & Operations study director
Sanofi
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAR279356 in people with Infection Prophylaxis, run by Sanofi at 6 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?
The sponsor lists 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Difficulty in patient recruitment in the participating sites). Results are not available in the source record.
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?
Pharmacokinetics parameters of SAR279356 : Ceoi, AUClast and CL (time frame: 90 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 12 Dec 2014.