MIST1
Trial question
What is the role of intrapleural administration of streptokinase in patients with pleural infection?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 430
430 patients (131 female, 299 male).
Inclusion criteria: adult patients with pleural infection.
Key exclusion criteria: age < 18 years; coincidental serious illness making survival at 3 months unlikely; previous intra-pleural fibrinolytic therapy for this empyema; previous video-assisted thoracoscopic drainage; thoracotomy; pleural decortication or open surgical drainage for this empyema; known sensitivity to streptokinase.
Interventions
N=208 streptokinase (intrapleural dose of 250,000 IU BID for 3 days).
N=222 placebo (matching placebo for 3 days).
Primary outcome
Death or need for surgical intervention
31%
27%
31.0 %
23.3 %
15.5 %
7.8 %
0.0 %
Streptokinase
Placebo
No significant
difference ↔
No significant difference in death or need for surgical intervention (31% vs. 27%; RR 1.14, 95% CI 0.85 to 1.54).
Secondary outcomes
No significant difference in death at 12 months (23% vs. 20%; RR 1.12, 95% CI 0.77 to 1.61).
No significant difference in surgical drainage at 12 months (18% vs. 16%; RR 1.16, 95% CI 0.75 to 1.77).
No significant difference in median duration of hospital stay (13 days vs. 12 days; AD 1 days, 95% CI -0.39 to 2.39).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients with pleural infection, streptokinase was not superior to placebo with respect to death or need for surgical intervention.
Reference
Nicholas A Maskell, Christopher W H Davies, Andrew J Nunn et al. U.K. Controlled trial of intrapleural streptokinase for pleural infection. N Engl J Med. 2005 Mar 3;352(9):865-74.
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