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A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin
Benjamin DK, Schelonka R, White R, Holley HP, Bifano E, Cummings J, Adcock K, Kaufman D, Puppala B, Riedel P, et al
Journal of Perinatology. 2006;26((5):):290-5.
Abstract
OBJECTIVES Very 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. METHODS A 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. RESULTS Of 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. CONCLUSIONS Infusion 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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Intravenous immunoglobulin prophylaxis in neonates on artificial ventilation
Adhikari M, Wesley AG, Fourie PB
South African Medical Journal. 1996;86((5):):542-5.
Abstract
The efficacy of the prophylactic use of intravenous immunoglobulin (Ig) was evaluated in a double-blind placebo-controlled trial of 21 pairs of ventilated neonates weighing more than 1,500 g. Each infant received 0.4 g/kg/day of intravenous Ig or a similar volume of placebo daily for 5 days. Criteria used to assess the efficacy of intravenous Ig were the number of infections, the duration of ventilation therapy and time to clinical recovery. There were no significant differences in the treated and placebo groups with regard to the frequency of positive blood cultures (28.6% and 14.3%), endotracheal cultures (57.1% and 66.7%) and abnormal white cell counts (52.4% and 57.1%). On entry to the study there was no significant difference in IgG levels between the treated (974.5 mg/dl; SD 575.3) and placebo groups (818 mg/dl; SD 516.9). However, on day 6 the treated group had a mean level of 1,400.3 mg/dl (SD 426.7) versus 710.9 mg/dl (SD 377.4) in the placebo group (P < 0.05). Clinical improvement occurred within 3 days in both groups. Ventilatory support was required for 11.8 days (SD 8.3) in the treated and 11.8 days (SD 7.3) in the placebo group. Both groups required 3-4 antibiotic treatments over a period of 14-15 days. Two patients died in the treated and 4 in the placebo group, with 1 infant in each group developing bronchopulmonary dysplasia. The patients who recovered did so within 14 days. Analyses of subgroups of patients with different diagnoses revealed no differences except a trend suggesting fewer infections in term babies treated with intravenous Ig. The organisms cultured in the intravenous Ig groups were Pseudomonas, Klebsiella, Escherichia coli and Staphylococcus and in the placebo group Pseudomonas, Klebsiella and Enterobacter. The above has shown that, except for a trend in the older neonates, intravenous Ig is not of prophylactic benefit in ventilated neonates. Newer adjuncts in immunotherapy such as hyperimmune gammaglobulin or monoclonal antibodies may prove of greater value in the treatment of neonatal sepsis.
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3.
Comparison of group B streptococcal hyperimmune globulin and standard intravenously administered immune globulin in neonates
Weisman LE, Anthony BF, Hemming VG, Fischer GW
Journal of Pediatrics. 1993;122((6):):929-37.
Abstract
Standard intravenously administered immune globulin (IVIG) contains varying amounts of group B streptococcus (GBS) antibody. A GBS hyperimmune IVIG was produced by immunizing plasma donors. The GBS type-specific opsonic activity was > or = 90% in the hyperimmune IVIG at a 1280 dilution-1 versus at a 10 dilution-1 in standard IVIG. Suckling rat survival after GBS type-specific infection was 100% when the rats were treated with hyperimmune IVIG versus < or = 20% with standard IVIG. To evaluate the effect of this product on GBS antibody levels and clinical toxic effects, we randomly administered either GBS hyperimmune IVIG, 500, 250, or 100 mg/kg, or standard IVIG, 500 mg/kg, to 20 neonates with suspected sepsis. No adverse effects were observed. Total and subclass serum IgG levels reflected only the dose; serum GBS type-specific IgG and opsonic activity reflected both the product and dose of IVIG administered. Standard IVIG did not significantly increase serum GBS type-specific IgG, whereas hyperimmune IVIG, 500 mg/kg, produced a fourfold rise for > 6 weeks; more variable increases were observed after 250 and 100 mg/kg doses were given. Serum GBS type-specific opsonic activity correlated with serum GBS type-specific IgG levels (R2 = 0.74; p < 0.0001). Further studies of this or similar products will be necessary to determine whether GBS type-specific antibody improves the outcome of GBS-infected neonates.
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4.
Potential use of intravenous immune globulin for group B streptococcal infection
Baker CJ, Noya FJ
Reviews of Infectious Diseases. 1990;12((Suppl 4):):S476-82.
Abstract
Several lines of evidence suggest that passive immunization as adjunctive therapy for or prevention of group B streptococcal (GBS) sepsis in neonates will require the use of preparations of human intravenous immune globulin (IVIG) that are hyperimmune for protective antibodies to GBS. Results from both in vitro and in vivo experiments utilizing commercially available IVIG preparations suggest that the doses necessary for achieving levels of pathogen-specific antibody capable of promoting efficient opsonization and phagocytosis of GBS may be prohibitive. Several laboratories have reported that standard IVIG preparations contain only modest levels of antibodies to the four capsular polysaccharides of GBS (the protective moieties), are variable in their effect on in vitro opsonophagocytosis by dose and method of preparation, and are significantly less protective in animal models than is IVIG prepared from adults immunized with GBS polysaccharide vaccines. Further, when we gave a single infusion of standard IVIG at a dose of either 500 or 750 mg/kg to 10 premature neonates during the first week of life, opsonophagocytosis of type III GBS by their sera and adult neutrophils was observed only when high levels of specific antibody were achieved, levels only transiently achieved in nonimmune infants. Commercial preparation of human immune globulin hyperimmune for GBS will be required for optimal adjunctive therapy in patients with sepsis due to GBS and for the possible prevention of late-onset infant disease.
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Use of Pseudomonas immunoglobulin in artificially respirated patients at an interdisciplinary surgical intensive care unit . German
Class I, Junginger W, Kloss T
Infection. 1987;15((1):):76-9.
Abstract
The clinical efficacy and safety of a new pseudomonas hyperimmune globulin for intravenous administration were examined in 30 patients in a prospective randomized study. Although the statistical evaluation of the measurable parameters did not show relevant differences between the therapy group (n = 15) and the controls (n = 15), the clinical course of the disease was markedly better in patients treated with hyperimmune globulin. In the control group, three patients died from Pseudomonas aeruginosa infections, but none in the therapy group. The preparation was very well tolerated.
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6.
Use of pseudomonas immunoglobulin in ventilated patients at an interdisciplinary surgical intensive care station . German
Class I, Junginger W, Kloss T
Infection. 1987;15((Suppl 2):):S67-70.
Abstract
The clinical efficacy and safety of a new pseudomonas hyperimmune globulin for intravenous administration were examined in 30 patients in a prospective randomized study. Although the statistical evaluation of the measurable parameters did not show relevant differences between the therapy group (n = 15) and the controls (n = 15), the clinical course of the disease was markedly better in patients treated with hyperimmune globulin. In the control group, three patients died from Pseudomonas aeruginosa infections, but none in the therapy group. The preparation was very well tolerated.
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7.
Prevention using a Pseudomonas immunoglobulin in burn patients . German
Stuttmann R, Petrovici V, Hartert M
Infection. 1987;15((1):):80-4.
Abstract
Pseudomonas aeruginosa belongs to the most frequent pathogens isolated from patients with burns. In a mouse model for artificial burns it was found that prophylactic administration of a hyperimmune globulin with antibody titres against P. aeruginosa (Fisher immunotypes 1, 2, 4 and 6) reduced mortality. Therefore, the prophylactic administration of Pseudomonas immunoglobulin was examined in a prospective randomized study in two groups of 13 patients each. Severely burned patients with at least second degree burns over 30% to 70% of the total body surface area received 250 mg Pseudomonas immunoglobulin/kg body weight by the intravenous route between days 3 and 13. After treatment, plasma IgG levels were significantly raised between days 7 and 16 as compared to the controls, yet the incidence of infections caused by P. aeruginosa was not reduced. However, only two of the six infected patients, developed septicaemia, whereas in the control group, local Pseudomonas infection led to septicaemia in five out of seven patients. The number of septicaemic Staphylococcus aureus infections was also lower in patients on immunoglobulin prophylaxis, with two cases compared to four cases in the control group. Due to the limited number of cases studied, statistically significant results could not be obtained, however, there was a positive trend in favour of Pseudomonas immunoglobulin treatment.
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8.
Pseudomonas immunoglobulin prophylaxis in patients with burn injuries . German
Stuttmann R, Petrovici V, Hartert M
Infection. 1987;15((Suppl 2):):S71-5.
Abstract
Pseudomonas aeruginosa belongs to the most frequent pathogens isolated from patients with burns. In a mouse model for artificial burns it was found that prophylactic administration of a hyperimmune globulin with antibody titres against P. aeruginosa (Fisher immunotypes 1, 2, 4 and 6) reduced mortality. Therefore, the prophylactic administration of Pseudomonas immunoglobulin was examined in a prospective randomized study in two groups of 13 patients each. Severely burned patients with at least second degree burns over 30% to 70% of the total body surface area received 250 mg Pseudomonas immunoglobulin/kg body weight by the intravenous route between days 3 and 13. After treatment, plasma IgG levels were significantly raised between days 7 and 16 as compared to the controls, yet the incidence of infections caused by P. aeruginosa was not reduced. However, only two of the six infected patients, developed septicaemia, whereas in the control group, local Pseudomonas infection led to septicaemia in five out of seven patients. The number of septicaemic Staphylococcus aureus infections was also lower in patients on immunoglobulin prophylaxis, with two cases compared to four cases in the control group. Due to the limited number of cases studied, statistically significant results could not be obtained, however, there was a positive trend in favour of Pseudomonas immunoglobulin treatment.
