Staphylococcal SepsisPhase 2/3NCT00646399
Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis
A Phase 2/3 study testing Pagibaximab 50 mg/mL in people with Staphylococcal Sepsis, run by Biosynexus Incorporated at 1 site in United States.
Trial summary
Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing staphylococcal sepsis in very low birth weight infants. 1550 infants will be enrolled prior to 48 hours of life and will be randomized 1:1 to receive active drug or placebo on study days 0, 1, 2, 9, 16, and 23. Read more about this study
- Who is it for?
- Ages Up to 48 hoursHealthy volunteers can take part
- Conditions the study is for
- Staphylococcal Sepsis
- What is being tested?
- Pagibaximab 50 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,579 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to May 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- In-patient at a Neonatal Intensive Care Unit (NICU)
- Informed consent obtained from the legally authorized representative
- Less than 48 hours old at the time of first infusion
- Birth weight between 600 grams and 1200 grams
- Estimated gestation age ≤33 weeks
- For multiple gestations, twins may be enrolled if they each meet the entry criteria. They will both be assigned to the same treatment group.
Who cannot join
- Infants with history of a hypersensitivity or severe vasomotor reaction to any antibody preparation.
- Infants with proven staphylococcal infection prior to randomization.
- Infants with a concomitant infection or other medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk.
- Immunodeficiency other than due to prematurity.
- Currently receiving, recently received, or planned to receive other investigational agents that could interfere with conduct or results of this study.
- Severe congenital or chromosomal anomaly that would limit life expectancy or required corrective measures during the period of this study
- Uncontrolled seizures
Trial locations and contacts
1 site in 1 country.
United States1 site
Biosynexus Incorporated
Gaithersburg, Maryland, 20877
About this study
Official title: A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight (VLBW) Neonates for the Prevention of Staphylococcal Sepsis
Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing staphylococcal sepsis in very low birth weight infants. 1550 infants will be enrolled prior to 48 hours of life and will be randomized 1:1 to receive active drug or placebo on study days 0, 1, 2, 9, 16, and 23.
Read the detailed description
Phase 2b/3, randomized, double-blind, multicenter, placebo-controlled study evaluating the safety, efficacy and pharmacokinetics (PK) of pagibaximab (100 mg/kg/dose) in comparison to placebo for the prevention of staphylococcal sepsis in VLBW infants (600 -1200 grams). Subjects monitored for treatment related adverse events and tolerability to infusion of study drug. Neonatal sepsis will be assessed in the presence of clinical signs and symptoms and one blood culture positive for S. aureus or two blood cultures positive for Coagulase Negative Staphylococci (CoNS). The study period will be 35 days after the first dose or until, death, discharge, or transfer, whichever occurs first.
- Conditions
- Staphylococcal Sepsis
- Being tested
- Placebo, Pagibaximab 50 mg/mL
- Keywords
- Staphylococcal, Coagulase Negative Staphylococcus, Monoclonal antibodies, Very Low Birth Weight Infants, Prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Phosphate Buffered Saline on Days 0, 1, 2, 9, 16 and 23.
Pagibaximab 50 mg/mLDrug
Pagibaximab 100 mg/kg dosed on Days 0, 1, 2, 9, 16 and 23
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Phosphate Buffered Saline Receives: Drug: Placebo |
| Pagibaximab 50 mg/mL | Experimental | Pagibaximab at 100 mg/kg intravenously at Days 0, 1, 2, 9, 16 and 23. Receives: Drug: Pagibaximab 50 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.
Safety and efficacy
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startMar 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Staphylococcal SepsisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,579 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosynexus Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646399
- Sponsor's protocol ID
- MAB-N007
- Status last verified
- Oct 2011
- First submitted
- 26 Mar 2008
- Last updated
- 24 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight (VLBW) Neonates for the Prevention of Staphylococcal Sepsis
- ClinicalTrials.gov ID
- NCT00646399
- Acronym / sponsor ID
- MAB-N007
- Conditions
- Staphylococcal Sepsis
- Keywords
- Staphylococcal, Coagulase Negative Staphylococcus, Monoclonal antibodies, Very Low Birth Weight Infants, Prophylaxis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,579 participants (actual)
- Lead sponsor
- Biosynexus IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 28 Mar 2008 (estimated)
- Results
- Posted 24 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing staphylococcal sepsis in very low birth weight infants. 1550 infants will be enrolled prior to 48 hours of life and will be randomized 1:1 to receive active drug or placebo on study days 0, 1, 2, 9, 16, and 23.
Detailed description
Phase 2b/3, randomized, double-blind, multicenter, placebo-controlled study evaluating the safety, efficacy and pharmacokinetics (PK) of pagibaximab (100 mg/kg/dose) in comparison to placebo for the prevention of staphylococcal sepsis in VLBW infants (600 -1200 grams). Subjects monitored for treatment related adverse events and tolerability to infusion of study drug. Neonatal sepsis will be assessed in the presence of clinical signs and symptoms and one blood culture positive for S. aureus or two blood cultures positive for Coagulase Negative Staphylococci (CoNS). The study period will be 35 days after the first dose or until, death, discharge, or transfer, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPhosphate Buffered Saline |
| Pagibaximab 50 mg/mL | Experimental | Drug: Pagibaximab 50 mg/mLPagibaximab at 100 mg/kg intravenously at Days 0, 1, 2, 9, 16 and 23. |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- In-patient at a Neonatal Intensive Care Unit (NICU)
- Informed consent obtained from the legally authorized representative
- Less than 48 hours old at the time of first infusion
- Birth weight between 600 grams and 1200 grams
- Estimated gestation age ≤33 weeks
Key exclusion criteria (7 listed)
- Infants with history of a hypersensitivity or severe vasomotor reaction to any antibody preparation.
- Infants with proven staphylococcal infection prior to randomization.
- Infants with a concomitant infection or other medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk.
- Immunodeficiency other than due to prematurity.
- Currently receiving, recently received, or planned to receive other investigational agents that could interfere with conduct or results 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 |
|---|---|---|
| PlaceboPhosphate Buffered Saline on Days 0, 1, 2, 9, 16 and 23. | Drug | Placebo |
| Pagibaximab 50 mg/mLPagibaximab 100 mg/kg dosed on Days 0, 1, 2, 9, 16 and 23 | Drug | Pagibaximab 50 mg/mL |
Primary outcome
The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.
Time frame: 35 days
Safety and efficacy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Staphylococcal Sepsis
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Active, not recruitingObservational study
Immune Resolution After Staphylococcus Aureus Bacteremia
Immune Response To Sepsis, Staphylococcus Aureus Infection
Recruiting
Linezolid Plus Standard of Care
Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia)
RecruitingPhase 4
Comparison of Cloxacillin and Benzylpenicillin in Penicillin Susceptible S. Aureus Bacteraemia
Staphylococcus Aureus Bacteraemia, Staphylococcal Bacteraemia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pagibaximab 50 mg/mL in people with Staphylococcal Sepsis, run by Biosynexus Incorporated at 1 site 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 6 inclusion and 7 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 24 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 24 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35. (time frame: 35 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 24 Oct 2011.