Trial reportJournal of perinatology : official journal of the California Perinatal Association2006
A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin.
Trial report in Journal of perinatology : official journal of the California Perinatal Association, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
43 citing papers in PubMed, 2 syntheses or guidelines pooled it, 102 citations in OpenAlex.
- The evolving landscape ofFrontiers in immunology · 2026Pooled it
- Antistaphylococcal immunoglobulins to prevent staphylococcal infection in very low birth weight infants.The Cochrane database of systematic reviews · 2009Pooled it
- 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.Antimicrobial agents and chemotherapy · 2007Trial
- Passive immunization through polyclonal antibodies against IsdE showed protective activity in an experimental S.aureus challenge model.Folia microbiologica · 2026Article
- Methicillin-resistant and susceptible Staphylococcus aureus: tolerance, immune evasion and treatment.Nature reviews. Microbiology · 2026Review
- Potent human antibodies against SpA5 identified by high-throughput single-cell sequencing of phase I clinical volunteers' B cells.iScience · 2025Article
- Methicillin-resistantCurrent pharmaceutical biotechnology · 2025Review
- The immune evasion roles ofFrontiers in cellular and infection microbiology · 2023Review
- Review
- Investigational agents for the treatment of methicillin-resistantExpert opinion on investigational drugs · 2022Article
- Immune-Based Anti-Staphylococcal Therapeutic Approaches.Microorganisms · 2021Review
- T Cell Immunity and the Quest for Protective Vaccines againstMicroorganisms · 2020Review
- Article
- Fighting Staphylococcus aureus Biofilms with Monoclonal Antibodies.Trends in microbiology · 2019Review
- Stress-induced inactivation of the Staphylococcus aureus purine biosynthesis repressor leads to hypervirulence.Nature communications · 2019Article
- Molecular epidemiology and expression of capsular polysaccharides in Staphylococcus aureus clinical isolates in the United States.PloS one · 2019Article
- Antibody-Based Agents in the Management of Antibiotic-Resistant Staphylococcus aureus Diseases.Microorganisms · 2018Review
- Immunomodulation to Prevent or Treat Neonatal Sepsis: Past, Present, and Future.Frontiers in pediatrics · 2018Review
- Antibodies to Staphylococcus aureus capsular polysaccharides 5 and 8 perform similarly in vitro but are functionally distinct in vivo.Virulence · 2017Article
- Infective endocarditis.Nature reviews. Disease primers · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 11 institutions in 1 country.
Funding
Abstract
objectivesVery low birth weight (VLBW) infants are vulnerable to nosocomial infections and subsequent morbidity; including infections caused by Staphylococcus aureus: 85% of nosocomial S. aureus infections are caused by capsular polysaccharide (CPS) types 5 and 8. Altastaph is a polyclonal investigational human immunoglobulin G (IgG) with high levels of opsonizing S. aureus CPS types 5 and 8 IgG.
methodsA Phase 2 clinical trial to assess the safety and kinetics of Altastaph in VLBW infants. Neonates in this multicenter study were randomized to receive two identical 20 ml/kg i.v. infusions of either 0.45% NaCl placebo or 1000 mg Altastaph/kg. Each infant was followed for 28 days after the second infusion or until discharge. Serum S. aureus CPS types 5 and 8 IgG levels were measured preinfusion and at various times after each infusion.
resultsOf 206 neonates, 158 received both infusions. Adverse events were similar in the two treatment groups. Six subjects (3% in each group) discontinued owing to an adverse event. Geometric mean anti-type 5 IgG levels were 402 and 642 mcg/ml 1 day following infusion of the first (day 0) and Second (day 14) doses, respectively, in neonates < or =1000 g and slightly higher in neonates 1001 to 1500 g. Trough levels before second infusion were 188 mcg/ml. Type 8 IgG levels were similar. Geometric mean IgG levels among placebo recipients were consistently <2 and <5 mcg/ml for types 5 and 8 in both weight groups. Three episodes of S. aureus bacteremia occurred in each arm.
conclusionsInfusion of Altastaph in VLBW neonates resulted in high levels of specific S. aureus types 5 and 8 CPS IgG. The administration of this anti-staphylococcal hyperimmune globulin was well tolerated in this population.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.