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Sepsis related to BCG

This document is an evidence-based summary to complement treatment protocols and includes background and rationale for specific point of care actions. It is not intended to be a comprehensive literature review of all available evidence.

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Definition

BCG treatment carries a small but potentially fatal risk of developing an infection, with reports ranging from 1 to 5 %.rr

Onset/duration

Onset usually occurs within days to weeks of BCG administration, but can present several months after treatment.r

Risk factors

Risk factors for BCG related sepsis include:r

  • traumatic catheterisation
  • macroscopic haematuria
  • instillation within 30 days of transurethral surgery
  • urinary tract infection
  • concomitant use of immunosuppressive therapy
  • age ≥70 years.

Symptoms and signs

Systemic complications of BCG infection can present as:r

  • high fever 38oC for at least 48 hours
  • chills and rigours
  • drenching night sweats
  • sepsis
  • organ specific infection e.g.
    • respiratory complications e.g. dyspnoea, acute respiratory distress syndrome (ARDS), pneumonitis
    • haematological complications e.g. cytopenia, immune thrombocytopenia
    • hepatitis
    • vascular complications e.g. mycotic aneurysms
    • epididymitis
    • prostatitis

Other serious adverse effects include reactive arthritis – conjunctivitis, joint pain, urethritis in men and cervicitis in women. This is a cross reactivity reaction and requires supportive treatment and discontinuation of BCG.

Investigations and diagnosis

Any patients who are suspected of having BCG related sepsis should be admitted to hospital with a full septic workup, including blood and urine cultures to screen for the presence of AFB strain, mycobacterial NAA test, and Mycobacterium bovis.

Treatment

There are no guidelines relating to the optimal approach to management of systemic BCG sepsis. If suspected, anti-tuberculosis therapy should be commenced in consultation with a infectious diseases physician. BCG organisms are susceptible to most currently used antituberculosis drug and should be treated using the treatment schedules for tuberculosis infections. Patients with symptoms of sepsis should be commenced on broad-spectrum antibiotics according to local policy.

Further treatment with BCG is contraindicated.

Educate the patient:

  • about the risks and signs and symptoms of BCG related sepsis
  • the importance of reporting symptoms of UTI and the presence of blood in urine
  • to go to the nearest hospital emergency department if the patient develops a persistent fever 38°C, any symptoms of sepsis, or drenching night sweats.
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Version 5

Date Summary of changes
11/10/2022

Document was subjected to internal eviQ review. Information updated and references added:

  • Background - incidence 
  • Assessment - risk factors, symptoms
  • Management 

Version number increased to V.5. Next review in 2 years.
15/03/2024 Document electronically reviewed by urogenital medical oncology reference committee, the management section updated to recommend consultation with an infectious diseases physician for BCG sepsis. Next review in 4 years. 

Version 4

Date Summary of changes
20/09/2010 First approved on eviQ. Version 1.
30/06/2015 Reviewed and reformatted. Version 2.

31/05/2017

Transferred to new eviQ website. Version 3.
16/07/2019 Reviewed and updated to align with information relating to currently available Mycobacterium bovis strain. Version number increased to V.4.

This document reflects what is currently regarded as safe practice. While every effort has been made to ensure the accuracy of the content at the time of publication, the Cancer Institute NSW does not accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omission in the contents of this work. Any reference throughout the document to specific pharmaceuticals and/or medical products as examples does not imply endorsement of any of these products. While eviQ endeavours to link to reliable sources that provide accurate information, eviQ and the Cancer Institute NSW do not endorse or accept responsibility for the accuracy, currency, reliability or correctness of the content of linked external information source. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

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https://www.eviq.org.au/p/1751

06 Jun 2025