Staphylococcal SepsisPhase 2N003NCT00631800
Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110
A Phase 2 study testing Pagibaximab (formerly BSYX-A110) in people with Staphylococcal Sepsis, run by Biosynexus Incorporated at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety (including tolerability), pharmacokinetics, pharmacodynamics and clinical activity of BSYX-A110 administered in a 3-dose regimen on Study Days 0, 7, and 14. Read more about this study
- Who is it for?
- Ages 48 to 120 hoursHealthy volunteers can take part
- Conditions the study is for
- Staphylococcal Sepsis
- What is being tested?
- Pagibaximab (formerly BSYX-A110)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Nov 2004
- 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 48 to 120 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients must meet all of the following criteria at the time of first infusion (Day 0):
- 48-120 hours of age, inclusive
- Birth weight of 700-1300 grams
- Inpatient in a Neonatal Intensive Care Unit
- Written informed consent obtained from the parent(s) or legal guardian
- Multiple gestations:
- Siblings from multiple gestations may be enrolled if they each meet the entry criteria
- No more than 4 subjects in any birth weight cohort may be siblings
Who cannot join
- Patients may have none of the following at the first dose:
- Survival not expected for at least 1 week after infusion
- Clinically overt systemic infection, as determined by history, physical examination, and positive culture from a normally sterile site. (Infuse only when infant clinically stable and cultures negative for 48 hours. If being evaluated for sepsis, decision to infuse may be deferred as allowed by protocol infusion window. Infusions outside of protocol window must be approved by Sponsor.)
- Severe congenital anomalies or genetic disorders that are likely to be fatal or that may interfere with drug distribution or metabolism, as determined by history and/or physical examination, and including but not limited to:
- Trisomy 13 ii. Trisomy 18 iii. Hypoplastic Left Heart Syndrome iv. Omphalocele v. Gastroschesis vi. Holoprosencephaly
- Known or suspected hepatic or renal insufficiency
Show all 13Show fewer
- Clinically uncontrolled seizures
- Immunodeficiency other than due to prematurity
- A history of standard immune globulin administration prior to first study drug infusion (excluding Hepatitis B Immune Globulin, HBIG)
- Any history, in the infant subject or its mother, of a hypersensitivity or severe vasomotor reaction to immunoglobulin G, or blood products
- Currently receiving, recently received, or planned to receive other investigational agents that could interfere with conduct or results of this study; including enrollment in another investigational study for a product under an IRB-approved protocol
- Expectation that the patient will not be able to be followed for the duration of the study
- Mother with serology positive for hepatitis B surface antigen
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Children's Hospital/Ben Taub Hospital (Baylor College of Medicine)
Houston, Texas, 77030
About this study
Official title: Phase II Randomized, Double Blind, Placebo Controlled, Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110, for the Prevention of Staphylococcal Infection
The purpose of this study is to evaluate the safety (including tolerability), pharmacokinetics, pharmacodynamics and clinical activity of BSYX-A110 administered in a 3-dose regimen on Study Days 0, 7, and 14.
Read the detailed description
This Phase II study will be a randomized, double blind, placebo controlled study of BSYX-A110 in very low birth weight neonates. A total of 80 infants will be dosed in this study. Participants will receive either BSYX-A110 or placebo, at 60 mg/kg or 90 mg/kg. The Study Drug will be administered at 48-120 hours of life, 7 days after the initial dose, and 14 days after the initial dose for all dose groups.
- Conditions
- Staphylococcal Sepsis
- Being tested
- Pagibaximab (formerly BSYX-A110)
- Keywords
- Staphylococcal, 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.
Pagibaximab (formerly BSYX-A110)Drug
Also called BSYX-A110, HU96-110, Pagibaximab
Pagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Pagibaximab (formerly BSYX-A110) |
| 60 mg/kg | Experimental | 60 mg/kg was given on Days 0, 7, 14 Receives: Drug: Pagibaximab (formerly BSYX-A110) |
| 90 mg/kg | Experimental | 90 mg/kg was given on Days 0, 7, 14 Receives: Drug: Pagibaximab (formerly BSYX-A110) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and pharmacokinetics
Measured: 0 - 56 days
Secondary outcomes (1)
Pharmacodynamics, sepsis/bloodstream infection
Measured: 0 - 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startMay 2003
- Primary completionMar 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosynexus Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Investigators
- Leonard Weisman, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631800
- Sponsor's protocol ID
- MAB-N003
- Acronym
- N003
- Status last verified
- Feb 2008
- First submitted
- 29 Feb 2008
- Last updated
- 10 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weisman LE, Thackray HM, Steinhorn RH, Walsh WF, Lassiter HA, Dhanireddy R, Brozanski BS, Palmer KG, Trautman MS, Escobedo M, Meissner HC, Sasidharan P, Fretz J, Kokai-Kun JF, Kramer WG, Fischer GW, Mond JJ. A randomized study of a monoclonal antibody (pagibaximab) to prevent staphylococcal sepsis. Pediatrics. 2011 Aug;128(2):271-9. doi: 10.1542/peds.2010-3081. Epub 2011 Jul 25.
PubMed 21788224
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized, Double Blind, Placebo Controlled, Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110, for the Prevention of Staphylococcal Infection
- ClinicalTrials.gov ID
- NCT00631800
- Acronym / sponsor ID
- N003 / MAB-N003
- Conditions
- Staphylococcal Sepsis
- Keywords
- Staphylococcal, Monoclonal antibodies, Very Low Birth Weight Infants, Prophylaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Biosynexus IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- May 2003
- Primary completion
- Mar 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 10 Mar 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 evaluate the safety (including tolerability), pharmacokinetics, pharmacodynamics and clinical activity of BSYX-A110 administered in a 3-dose regimen on Study Days 0, 7, and 14.
Detailed description
This Phase II study will be a randomized, double blind, placebo controlled study of BSYX-A110 in very low birth weight neonates. A total of 80 infants will be dosed in this study. Participants will receive either BSYX-A110 or placebo, at 60 mg/kg or 90 mg/kg. The Study Drug will be administered at 48-120 hours of life, 7 days after the initial dose, and 14 days after the initial dose for all dose groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Pagibaximab (formerly BSYX-A110)Placebo |
| 60 mg/kg | Experimental | Drug: Pagibaximab (formerly BSYX-A110)60 mg/kg was given on Days 0, 7, 14 |
| 90 mg/kg | Experimental | Drug: Pagibaximab (formerly BSYX-A110)90 mg/kg was given on Days 0, 7, 14 |
Who may qualify
- Ages
- 48 to 120 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 48-120 hours of age, inclusive
- Birth weight of 700-1300 grams
- Inpatient in a Neonatal Intensive Care Unit
- Written informed consent obtained from the parent(s) or legal guardian
- Siblings from multiple gestations may be enrolled if they each meet the entry criteria
Key exclusion criteria (13 listed)
- Survival not expected for at least 1 week after infusion
- Clinically overt systemic infection, as determined by history, physical examination, and positive culture from a normally sterile site. (Infuse only when infant clinically stable and cultures negative for 48 hours. If being evaluated for sepsis, decision to infuse may be deferred as allowed by protocol infusion window. Infusions outside of protocol window must be approved by Sponsor.)
- Severe congenital anomalies or genetic disorders that are likely to be fatal or that may interfere with drug distribution or metabolism, as determined by history and/or physical examination, and including but not limited to:
- Known or suspected hepatic or renal insufficiency
- Clinically uncontrolled seizures
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 |
|---|---|---|
| Pagibaximab (formerly BSYX-A110)Also: BSYX-A110, HU96-110, PagibaximabPagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14 | Drug | 60 mg/kg, 90 mg/kg, Placebo |
Primary outcome
Safety and pharmacokinetics
Time frame: 0 - 56 days
1 secondary outcome
Pharmacodynamics, sepsis/bloodstream infection
Time frame: 0 - 56 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 10 Mar 2008.
- Derived from this study: PubMed 21788224Weisman LE, Thackray HM, Steinhorn RH, Walsh WF, Lassiter HA, Dhanireddy R, Brozanski BS, Palmer KG, Trautman MS, Escobedo M, Meissner HC, Sasidharan P, Fretz J, Kokai-Kun JF, Kramer WG, Fischer GW, Mond JJ. A randomized study of a monoclonal antibody (pagibaximab) to prevent staphylococcal sepsis. Pediatrics. 2011 Aug;128(2):271-9. doi: 10.1542/peds.2010-3081. Epub 2011 Jul 25.
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.
Leonard Weisman, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pagibaximab (formerly BSYX-A110) 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 8 inclusion and 13 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 10 Mar 2008. 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 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 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?
Safety and pharmacokinetics (time frame: 0 - 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00631800, which also lists 1 linked publication.
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 10 Mar 2008.