The first clinical trial completed by the Network was a randomized, controlled trial of Ketoconazole versus placebo in patients with acute lung injury and ARDS. Ketoconazole was chosen because of its anti-inflammatory actions noted in the laboratory and because previous Phase II clinical trials suggested benefit in patients with or at risk for ARDS. This trial was stopped early by the DSMB in January 1997 after finding Ketoconazole to be ineffective. The clinical trial results were published in JAMA in April 2000 (The ARDS Clinical Trials Network Authors for the ARDS Network. Ketoconazole for early treatment of Acute Lung Injury and Acute Respiratory Distress Syndrome. A randomized controlled trial. JAMA, 2000;283:1995-2002).
Protocol
