Staphylococcal InfectionsPhase 1/2NCT00063089
Safety and Behavior of S. Aureus Immune Globulin Intravenous(Human), [Altastaph] in Patients With S. Aureus Bacteremia and Continuing Fever
A Phase 1/2 study testing S. aureus Immune Globulin Intravenous (Human) 5% in people with Staphylococcal Infections, run by Nabi Biopharmaceuticals.
Trial summary
Altastaph has been developed to help the removal of S. aureus from the bloodstream. The main objective of this study will be to test the safety and behavior of Altastaph in patients with S.aureus bacteremia and continuing fever Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Staphylococcal Infections
- What is being tested?
- S. aureus Immune Globulin Intravenous (Human) 5%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Sep 2004
- Phase
- Phase 1/2
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female greater than or equal to 7 years of age
- Weight less then or equal to 150 kilograms
- Subjects willing to complete the full duration of the study, including the follow up visit to day 42
- Life expectancy will enable the subject to complete the duration of the study
- Female subjects of child-bearing potential, negative serum pregnancy test prior to the first infusion of study material. Female subjects of child-bearing potential must agree to use an effective method of birth control throughout the study. Abstinence is not considered an adequate birth control measure. Female subjects of non-child-bearing potential must have history of hysterectomy, bilateral surgical or radiation-induced oophorectomy, tubal ligation or evidence of post menopausal status
- Subject, legal guardian(s) or medical power of attorney must have given written informed consent/ assent
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- S. aureus bacteremia and persistent fever. S. aureus bacteremia is defined as the first blood culture positive for S. aureus (index blood culture). Persistent fever (qualifying fever) is defined as a temperature (greater then or equal to 100.4F or greater then or equal to 38C) occuring at least 24 hours after the index temperature was recorded and after the index blood culture was drawn
- Absolute Neutrophil Count (ANC) greater then or equal to 500 x 10^9 cells/L
- Subjects with malignancies may participate if:(1) The malignancy is a solid tumor (i.e. not lymphoma, leukemia, etc.)(2) The tumor has not metastasized to the bone marrow
Who cannot join
- Known hypersensitivity or previous anaphylaxis to polysaccharide or polysaccharide-conjugate vaccines or to any component of Altastaph
- Profound disability, assessed by the investigator, which would prevent participation in the study
- Known IgA deficiency
- Known HIV infection with CD4 count < 200 cells/L
- Presence of any conditions which, in the opinion of the investigator, places the subject at undo risk or potentially jeopardizes the quality of the data to be generated
- Pregnancy or breast feeding
- Use of investigational drug or biologic in the four weeks prior to screening and during the study. The only exception is use of investigational antineoplastic product if, and only if: (1) The product is not expected to result in sever and prolonged immunosuppression (2) The product is, itself, not immunologically-based (e.g. anti-tumor/ monoclonal antibodies, cancer vaccines or interleukins
About this study
Official title: Initial Safety and Pharmacokinetics Trial of Immune Globulin to Staphylococcus Aureus Capsule Polysaccharide (Altastaph) in Subjects With S. Aureus Bacteremia and Persistent Fever
Altastaph has been developed to help the removal of S. aureus from the bloodstream. The main objective of this study will be to test the safety and behavior of Altastaph in patients with S.aureus bacteremia and continuing fever
Read the detailed description
Staphylococcus aureus has been recognized as an important community - acquired and nosocomial pathogen. Because it is a common cause of osteomyelitis, endocarditis, and meningitis, S. aureus infections lead to considerable morbidity and mortality. The main objective of this study will be to test the safety and pharmacokinetics of Altastaph in patients with S. aureus bacteremia and persistent fever. This study will also assess the efficacy of Altastaph versus control.
- Conditions
- Staphylococcal Infections
- Being tested
- S. aureus Immune Globulin Intravenous (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.
S. aureus Immune Globulin Intravenous (Human) 5%Drug
| Study group | Role | What they receive |
|---|---|---|
| altastaph | Experimental | S. aureus Immune Globulin Intravenous (Human) 5% Receives: Drug: S. aureus Immune Globulin Intravenous (Human) 5% |
| Placebo | Placebo comparator | 0.45% Normal Saline Receives: Drug: S. aureus Immune Globulin Intravenous (Human) 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: 6 weeks
Secondary outcomes (2)
pharmacokinetics
Measured: 6 weeks
Efficacy
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2003 (estimated)
- Study startSep 2002
- Primary completionSep 2004
- Study completionSep 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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nabi Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063089
- Sponsor's protocol ID
- Nabi-1407
- Status last verified
- May 2012
- First submitted
- 19 Jun 2003
- Last updated
- 14 May 2012
- Results posted
- No
Publications
Rupp ME, Holley HP Jr, Lutz J, Dicpinigaitis PV, Woods CW, Levine DP, Veney N, Fowler VG Jr. Phase II, randomized, multicenter, double-blind, placebo-controlled trial of a polyclonal anti-Staphylococcus aureus capsular polysaccharide immune globulin in treatment of Staphylococcus aureus bacteremia. Antimicrob Agents Chemother. 2007 Dec;51(12):4249-54. doi: 10.1128/AAC.00570-07. Epub 2007 Sep 24.
PubMed 17893153
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
- Initial Safety and Pharmacokinetics Trial of Immune Globulin to Staphylococcus Aureus Capsule Polysaccharide (Altastaph) in Subjects With S. Aureus Bacteremia and Persistent Fever
- ClinicalTrials.gov ID
- NCT00063089
- Acronym / sponsor ID
- Nabi-1407
- Conditions
- Staphylococcal Infections
- Keywords
- Staphylococcal infection, Gram positive bacteria, Staphylococcus, Staphylococcus aureus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nabi BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 20 Jun 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.
Altastaph has been developed to help the removal of S. aureus from the bloodstream. The main objective of this study will be to test the safety and behavior of Altastaph in patients with S.aureus bacteremia and continuing fever
Detailed description
Staphylococcus aureus has been recognized as an important community - acquired and nosocomial pathogen. Because it is a common cause of osteomyelitis, endocarditis, and meningitis, S. aureus infections lead to considerable morbidity and mortality. The main objective of this study will be to test the safety and pharmacokinetics of Altastaph in patients with S. aureus bacteremia and persistent fever. This study will also assess the efficacy of Altastaph versus control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| altastaph | Experimental | Drug: S. aureus Immune Globulin Intravenous (Human) 5%S. aureus Immune Globulin Intravenous (Human) 5% |
| Placebo | Placebo comparator | Drug: S. aureus Immune Globulin Intravenous (Human) 5%0.45% Normal Saline |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female greater than or equal to 7 years of age
- Weight less then or equal to 150 kilograms
- Subjects willing to complete the full duration of the study, including the follow up visit to day 42
- Life expectancy will enable the subject to complete the duration of the study
- Female subjects of child-bearing potential, negative serum pregnancy test prior to the first infusion of study material. Female subjects of child-bearing potential must agree to use an effective method of birth control throughout the study. Abstinence is not considered an adequate birth control measure. Female subjects of non-child-bearing potential must have history of hysterectomy, bilateral surgical or radiation-induced oophorectomy, tubal ligation or evidence of post menopausal status
Key exclusion criteria (7 listed)
- Known hypersensitivity or previous anaphylaxis to polysaccharide or polysaccharide-conjugate vaccines or to any component of Altastaph
- Profound disability, assessed by the investigator, which would prevent participation in the study
- Known IgA deficiency
- Known HIV infection with CD4 count < 200 cells/L
- Presence of any conditions which, in the opinion of the investigator, places the subject at undo risk or potentially jeopardizes the quality of the data to be generated
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 |
|---|---|---|
| S. aureus Immune Globulin Intravenous (Human) 5% | Drug | Placebo, altastaph |
Primary outcome
Safety
Time frame: 6 weeks
2 secondary outcomes
pharmacokinetics
Time frame: 6 weeks
Efficacy
Time frame: 6 Weeks
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.
- Derived from this study: PubMed 17893153Rupp ME, Holley HP Jr, Lutz J, Dicpinigaitis PV, Woods CW, Levine DP, Veney N, Fowler VG Jr. Phase II, randomized, multicenter, double-blind, placebo-controlled trial of a polyclonal anti-Staphylococcus aureus capsular polysaccharide immune globulin in treatment of Staphylococcus aureus bacteremia. Antimicrob Agents Chemother. 2007 Dec;51(12):4249-54. doi: 10.1128/AAC.00570-07. Epub 2007 Sep 24.
- 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 1/2 study testing S. aureus Immune Globulin Intravenous (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?
The sponsor lists 9 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 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (time frame: 6 weeks). 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 NCT00063089, 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 14 May 2012.