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FDA clinical trial tables

The U.S. Food and Drug Administration (FDA) is informing the public that a recent clinical trial with Doribax (doripenem) was stopped early because of significant safety concerns. This trial, which was evaluating the effects of Doribax on treatment of patients with ventilator-associated pneumonia, demonstrated excess mortality and a numerically poorer clinical cure rate among subjects treated with Doribax compared to those treated with imipenem-cilastatin. FDA is reviewing the trial results and will communicate any new information that results from this investigation.

Healthcare professionals should be aware that Doribax is not approved to treat any type of pneumonia, nor is it approved for doses greater than 500 mg every eight hours.

Doribax is still considered safe and effective for its approved indications-treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections including pyelonephritis. The recommended dose of Doribax is 500 mg every eight hours intravenously, given over 1 hour, for a total of 5-14 days (depending on indication) in adults.

According to Janssen Research and Development LLC (Doribax's manufacturer), Table 1 below shows the interim results for both clinical cure rates and 28-day all-cause mortality rates for the Microbiological Intent-to-Treat (MITT) population and the Microbiologically Evaluable (ME) population.

Table 1. Summary of Clinical Cure Rates and All-Cause 28-Day Mortality Rate

Analysis Population Doripenem
2-sided 95%
Clinical Cure Rates
MITT 45.6 56.8 -11.2 -26.3 to 3.8
ME 49.1 66.1 -17 -34.7 to 0.8
All Cause 28-day Mortality Rate (MITT) 21.5 14.8 6.7 -5.0 to 18.5
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Does the European clinical trials directive really improve clinical trial approval time?

To facilitate and improve clinical research within Europe, the European Union (EU) adopted in 2001 the Clinical Trials Directive (EUCTD). The aim of this study was to compare duration between submission of a clinical drug trial application and approval by regulatory authorities in EU countries regulated by EUCTD vs. EU countries regulated by local legislation and, second, to compare the duration of regulatory approval in Europe vs. the USA and Australia.

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