U.K. Controlled Trial of Intrapleural Streptokinase for Pleural Infection
Nicholas A. Maskell, M.R.C.P., Christopher W.H. Davies, M.D., Andrew J. Nunn, M.Sc., Emma L. Hedley, Fergus V. Gleeson, F.R.C.P., Robert Miller, F.R.C.P., Rhian Gabe, M.Phil., Glyn L. Rees, Timothy E.A. Peto, F.R.C.P., Mark A. Woodhead, F.R.C.P., Donald J. Lane, F.R.C.P., Janet H. Darbyshire, M.B., Ch.B., Robert J.O. Davies, D.M., for the First Multicenter Intrapleural Sepsis Trial (MIST1) Group
Background Intrapleural fibrinolytic agents are used in thedrainage of infected pleural-fluid collections. This use isbased on small trials that did not have the statistical powerto evaluate accurately important clinical outcomes, includingsafety. We conducted a trial to clarify the therapeutic roleof intrapleural streptokinase.
Methods In this double-blind trial, 454 patients with pleuralinfection (defined by the presence of purulent pleural fluidor pleural fluid with a pH below 7.2 with signs of infectionor by proven bacterial invasion of the pleural space) were randomlyassigned to receive either intrapleural streptokinase (250,000IU twice daily for three days) or placebo. Patients receivedantibiotics and underwent chest-tube drainage, surgery, andother treatment as part of routine care. The number of patientsin the two groups who had died or needed surgical drainage atthree months was compared (the primary end point); secondaryend points were the rates of death and of surgery (analyzedseparately), the radiographic outcome, and the length of thehospital stay.
Conclusions The intrapleural administration of streptokinasedoes not improve mortality, the rate of surgery, or the lengthof the hospital stay among patients with pleural infection.
Source Information
From the Oxford Centre for Respiratory Medicine, Churchill Hospital Site, Oxford Radcliffe Hospital, Headington, Oxford (N.A.M., E.L.H., F.V.G., G.L.R., T.E.A.P., D.J.L., R.J.O.D.); the Department of Respiratory Medicine, Royal Berkshire Hospital, Reading (C.W.H.D.); the Medical Research Council Clinical Trials Unit, London (A.J.N., R.G., J.H.D.); the Department of Population Sciences and Primary Care, University College, London (R.M.); and the Department of Respiratory Medicine, Manchester Royal Infirmary, Manchester (M.A.W.) — all in the United Kingdom.
Address reprint requests to Dr. Davies at the Oxford Centre for Respiratory Medicine, Oxford Radcliffe Hospital, Headington, Oxford OX3 7LJ, United Kingdom, or at robert.davies{at}ndm.ox.ac.uk.
A Trial of Intrapleural Streptokinase
Katikireddy C. K., Dube D. S., Diacon A. H., Koegelenberg C. F.N., Bolliger C. T., Rosa U. W., Bouros D., Davies R. J.O., Maskell N. A., Nunn A. J.
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N Engl J Med 2005;
352:2243-2245, May 26, 2005.
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A correction has been published: N Engl J Med 2005;352(20):2146.
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