Staphylococcal InfectionsPhase 2NCT00066989
Safety Study of an Intravenous Staphylococcus Aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates
A Phase 2 study testing Staphylococcus aureus Immune Globulin (Human) 5% in people with Staphylococcal Infections, run by Nabi Biopharmaceuticals.
Trial summary
The main objective will be to test the safety of two intravenous infusions of Altastaph, a human immunoglobulin product. The study will also test the ability of Altastaph to protect against S. aureus infection. Read more about this study
- Who is it for?
- Ages 3 to 7 days
- Conditions the study is for
- Staphylococcal Infections
- What is being tested?
- Staphylococcus aureus Immune Globulin (Human) 5%
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Aug 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 3 to 7 days
- All sexes
- No healthy volunteers
- Child
The subject must conform to all of the following (Inclusion Criteria):
- Neonate with a birth weight between 501 and 1500 grams inclusive;
- Between 3 and 7 days of age, inclusive, at the time of first infusion (Day 0);
- Expected to survive at least 48 hours after infusion;
- Free of overt systemic infection, as determined by history, physical examination, radiologic studies, or laboratory studies including microbiology data; clinical safety tests required can be completed up to three (3) days prior to the infusion of the study product;
- Direct bilirubin less than or equal to 2.0 mg/dL;
- Serum creatinine level of less than or equal to 2.0 mg/dL; and
- Hemodynamically stabile; if the subject is receiving cardiac support including anti-arrhythmics, pressors, or cardiac pacing, the subject must be stable on that cardiac support and be expected not to require this support indefinitely.
The subject must not have any of the following (Exclusion Criteria):
- Known HIV infection, as documented by maternal history or positive PCR in the infant;
- Severe congenital anomaly or genetic disorder known to impact immune competence;
- Prior administration of any immune globulin;
- Any history, in the infant subject or its mother, of hypersensitivity or severe vasomotor reaction to any human blood product;
- Cyanotic congenital heart disease; and
- Central nervous system shunt
About this study
Official title: A Double Blind, Randomized, Multicenter Stratified Study to Assess the Safety of an Intravenous Staphylococcus Aureus Immune Globulin (Human) [Altastaph] in Low-Birth-Weight-Neonates
The main objective will be to test the safety of two intravenous infusions of Altastaph, a human immunoglobulin product. The study will also test the ability of Altastaph to protect against S. aureus infection.
Read the detailed description
Survival of Very-Low-Birth-Weight (VLBW) infants (<1500g at birth) has improved dramatically, but these patients remain subject to significant morbidity and mortality due to Staphylococcus aureus infection. S. aureus infection is a relatively common event in VLBW neonates, occurring in approximately 3.4% of very low birth weight neonates and accounting for 15-20% of all infections in this patient population. This controlled study will assess the safety, pharmacokinetics, and preliminary efficacy of Altastaph in LBW neonates. The study will be stratified by birth weight and include up to 200 LBW neonates, 3 to 7 days of age.
- Conditions
- Staphylococcal Infections
- Being tested
- Staphylococcus aureus Immune Globulin (Human) 5%
- Keywords
- Staphylococcal infection, Gram positive bacteria, Staphylococcus, Staphylococcus aureus
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staphylococcus aureus Immune Globulin (Human) 5%Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2003 (estimated)
- Study startJul 2003
- Primary completionAug 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcal InfectionsStudies 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
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Nabi Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066989
- Sponsor's protocol ID
- Nabi-1408
- Status last verified
- May 2012
- First submitted
- 8 Aug 2003
- Last updated
- 14 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Multicenter Stratified Study to Assess the Safety of an Intravenous Staphylococcus Aureus Immune Globulin (Human) [Altastaph] in Low-Birth-Weight-Neonates
- ClinicalTrials.gov ID
- NCT00066989
- Acronym / sponsor ID
- Nabi-1408
- Conditions
- Staphylococcal Infections
- Keywords
- Staphylococcal infection, Gram positive bacteria, Staphylococcus, Staphylococcus aureus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Nabi BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 11 Aug 2003 (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 main objective will be to test the safety of two intravenous infusions of Altastaph, a human immunoglobulin product. The study will also test the ability of Altastaph to protect against S. aureus infection.
Detailed description
Survival of Very-Low-Birth-Weight (VLBW) infants (<1500g at birth) has improved dramatically, but these patients remain subject to significant morbidity and mortality due to Staphylococcus aureus infection. S. aureus infection is a relatively common event in VLBW neonates, occurring in approximately 3.4% of very low birth weight neonates and accounting for 15-20% of all infections in this patient population. This controlled study will assess the safety, pharmacokinetics, and preliminary efficacy of Altastaph in LBW neonates. The study will be stratified by birth weight and include up to 200 LBW neonates, 3 to 7 days of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 3 to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Staphylococcus aureus Immune Globulin (Human) 5% | Drug | – |
Primary outcome
Not reported in the source record.
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 14 May 2012.
- Nabi BiopharmaceuticalsLink 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Staphylococcus aureus Immune Globulin (Human) 5% in people with Staphylococcal Infections, run by Nabi Biopharmaceuticals.
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 14 May 2012. 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 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.
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 14 May 2012.