This medical condition has either been superseded or has become inactive
Specific Conditions |
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Indication for Ig Use |
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Level of Evidence | Insufficient data (Category 4a) |
Description and Diagnostic Criteria |
Toxic shock syndrome (TSS) is an acute multi-system, toxin mediated illness typically resulting in shock and multi organ failure early in its clinical course. Particular toxins produced by S aureus and group A streptococcus (GAS) can act as ‘superantigens’ that bypass the normal antigen presenting processes of the immune system and instead bind directly to T cell antigen receptors, resulting in polyclonal T-cell stimulation and massive cytokine release. Key clinical features of TSS are hypotension often accompanied by fever or rash with rapid progression to shock and multi organ failure. Early recognition (and thus assessment for these criteria) followed by appropriate surgical intervention, antibiotics (including anti toxin agents such as clindamycin) and consideration of IVIg, are a corner stone of management. Streptococcal TSS is defined by: I. Group A streptococci (S. pyogenes) isolated from:
IIB. Two or more of the following:
A probable case is an illness fulfilling criteria IB and II (A and B) where no other aetiology is identified. (Working Group on Severe Streptococcal Infections 1993). Staphylococcal TSS (issued by the United States Centers for Disease Control and Prevention) is defined by:
A probable case is an illness with all but one of the manifestations above (Wharton et al 1990). Prognosis Streptococcal TSS has a mortality of 30–80 percent in adults and 5–10 percent children, with most deaths secondary to shock and respiratory failure. Staphylococcal TSS can also be fatal, but mostly has a better prognosis. |
Justification for Evidence Category |
Intravenous immunoglobulin (IVIg) has been reported to facilitate bacterial opsonisation, neutralise super antigens and toxins, stimulate leukocytes and exert a generalised anti-inflammatory effect through its effects on Fc receptor expression, complement, cytokines and B and T cells. There are a number of clinical studies supporting the use of IVIg, particularly for streptococcal TSS and less so for staphylococcal TSS. Observational cohort studies of patients treated with IVIg suggested increased the 30-day survival rates compared to untreated controls (Kaul et al, 1999 and Linner et al, 2014). In the absence of randomised controlled clinical trials, particularly in specific patient cohorts such as children, it is difficult to reliably quantify the benefit of IVIg therapy. However, given the severity of disease that can result from TSS and the relatively good safety profile of IVIg, coupled with the evidence suggesting potential benefit of IVIg, it is regarded as adjunctive therapy in cases of TSS. |
Diagnosis Requirements |
A diagnosis must be made by a General Medicine Physician, Intensivist or an Infectious Diseases Specialist. |
Qualifying Criteria for Ig Therapy |
Early use in streptococcal TSS
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Staphylococcal TSS where rapid improvement is not obtained with fluid resuscitation, inotropes, surgery, antibiotic therapy and other supportive measures
AND
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Review Criteria for Assessing the Effectiveness of Ig Use |
Early use in streptococcal TSS
Review is not mandated for this indication however the following criteria may be useful in assessing the effectiveness of Ig therapy.
Staphylococcal TSS where rapid improvement is not obtained with fluid resuscitation, inotropes, surgery, antibiotic therapy and other supportive measures
Review is not mandated for this indication however the following criteria may be useful in assessing the effectiveness of Ig therapy.
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Dose |
Early use in streptococcal TSS
Refer to the current product information sheet for further information on
dose, administration and contraindications. Staphylococcal TSS where rapid improvement is not obtained with fluid resuscitation, inotropes, surgery, antibiotic therapy and other supportive measures
Refer to the current product information sheet for further information on
dose, administration and contraindications. |
Bibliography |
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Carapetis, JR, Jacoby, P, Carville, K, et al 2014, ‘Effectiveness of clindamycin and intravenous immunoglobulin, and risk of disease in contacts, in invasive Group A streptococcal infections’, Clinical Infectious Diseases, vol. 59, pp. 358–65. http://cid.oxfordjournals.org/content/early/2014/04/29/cid.ciu304 Darenberg, J, Ihendyane, N, Sjolin, J, et al 2003, ‘Intravenous immunoglobulin G therapy in streptococcal toxic shock syndrome: a European randomized double-blind placebo- controlled trial’, Clinical Infectious Diseases, vol. 37, no. 3, pp. 333–40. https://www.ncbi.nlm.nih.gov/pubmed/12884156 Kaul, R, McGeer, A, Norrby-Teglund, A, et al 1999, ‘Intravenous immunoglobulin therapy for streptococcal toxic shock syndrome--a comparative observational study’, The Canadian Streptococcal Study Group, Clinical Infectious Diseases, vol. 28, no. 4, pp. 800–7. https://www.ncbi.nlm.nih.gov/pubmed/10825042 Lappin, E & Ferguson, AJ 2009, ‘Gram-positive toxic shock syndromes’, Lancet Infectious Diseases, vol. 9, no. 5, pp. 281–90. https://www.ncbi.nlm.nih.gov/pubmed/19393958 Linner, A, Darenberg, J, Sjolin, J, et al 2014, ‘Clinical efficacy of polyspecific intravenous immunoglobulin therapy in patients with streptococcal toxic shock syndrome: a comparative observational study’, Clinical Infectious Diseases, vol. 59, no.6, pp. 851–7. https://www.ncbi.nlm.nih.gov/pubmed/24928291 Shah, SS, Hall, M, Srivastava, R, et al 2009, ‘Intravenous immunoglobulin in children with streptococcal toxic shock syndrome’, Clinical Infectious Diseases, vol. 49, no. 9, pp. 1369–76. https://www.ncbi.nlm.nih.gov/pubmed/19788359 Waddington, CS, Snelling & TL, Carapetis, JR 2014, ‘Management of invasive group A streptococcal infections’, Journal of Infection, vol. 69, Suppl 1, pp. S63–9. https://www.ncbi.nlm.nih.gov/pubmed/25307276 Wharton, M, Chorba, TL, Vogt, RL, et al 1990, ‘Case definitions for public health surveillance’, Morbidity Mortality Weekly Report, vol. 39, no. RR-13, pp. 1-43. https://www.cdc.gov/mmwr/preview/mmwrhtml/00025629.htm Working Group on Severe Streptococcal Infections, 1993, ‘Defining the Group A streptococcal toxic shock syndrome: rationale and consensus definition’, Journal of the American Medical Association, vol. 269, no. 3, pp. 390–1. https://www.ncbi.nlm.nih.gov/pubmed/8418347 |