Ethical problems of evaluating a new treatment for melioidosis

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Abstract
Our problem Melioidosis, the infection caused by Burkholderia pseudomallei, is endemic in South East Asia1 and is the commonest cause of death from bacteraemic pneumonia in the Northern Territory of Australia.2Patients with severe infection present with septic shock, a condition associated with a high mortality. The Royal Darwin Hospital has treated 341 patients with culture confirmed melioidosis over 13 years, with an overall 18% mortality. Forty two of these patients presented with severe sepsis. In 1998, the hospital decided to start treating patients with melioidosis and septic shock withgranulocyte-colony stimulating factor (G-CSF). The decision was based on the evidence available atthat time (box). G-CSF was introduced at the same time as the hospital appointed a specialist in intensive care medicine. Previously, anaesthetists had supervised the unit, and the appointment resulted in appreciable changes to management protocols, including the more aggressive use of haemodynamic monitoring, empiric antibiotic protocols, the adoption of a closed intensive care model, andearly enteric feeding. Mortality from severe melioidosis fell from 95% (20 of 21 patients) to 10% (2 of 21 patients) (P < 0.001, Fisher's exact test).10 A more modest reduction also occurred in mortality from septic shock due to other pathogens.10 The fall in mortality was particularly surprising because newly published data suggested that G-CSF was of little benefit in non-neutropenic infection.8 11 12 Acknowledgments We thank Susan Jacups for data support References to work on patient equipoise are available on bmj.com

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