Additionally, one patient suffered a digestive haemorrhage related to an active peptic ulcer 12 days after inclusion in the study (3 days after MPDN and omeprazole had been discontinued). The patient did well following a conservative approach.DiscussionFew data have been published about the use of corticosteroids as R115777 an adjuvant anti-inflammatory treatment in CAP [14-16,19]. In order to demonstrate the hypothetical benefit of this strategy, we designed this prospective, double-blind, randomized study of patients with CAP and admitted because of: 1) large pulmonary consolidation; and 2) acute respiratory failure. Our results indicate that the administration of an adjuvant steroid therapy in combination with ceftriaxone plus levofloxacin significantly improved several clinical course variables such as the pO2/FiO2 ratio, the degree of radiological resolution and TRM score.
In addition, some inflammatory markers such as IL-6 and CRP showed significantly lower blood concentrations and a more favourable time-course in the MPDN group. Mechanical ventilation was needed in only one episode from the MPDN group compared with five cases in the control group, while the duration of ICU stay showed a clear trend in favour of the MPDN group. However, these differences did not reach statistical significance.The need for MV was chosen as the major endpoint for this trial and was preferred over mortality, as it appears to be a more multi-factor variable than the development of severe respiratory failure. Sample size calculation was determined on the basis of the findings reported by a limited number of studies [20,21] and our own clinical experience.
It would appear that the sample size is too small to confer statistical significance to the observed differences in this endpoint, but, were these differences to be maintained, a 50% larger sample size could be enough to achieve statistical significance. Nevertheless, the number of studied cases was enough to demonstrate significant differences in other relevant clinical variables, in particular the pO2/FiO2 ratio.Some studies have previously evaluated the impact of corticosteroid treatment in the prognosis of patients with CAP. In 1993, Marik et al.
 postulated that a low dose of hydrocortisone given prior to antibiotic therapy in ICU-admitted CAP patients could prevent the second wave of TNF-a release in the blood; however, the authors were unable to confirm this hypothesis and concluded that the hydrocortisone treatment had no effect on the serum TNF-a levels or on the clinical course of patients. In another study, Monton et al.  reported that a prolonged steroid treatment decreased systemic and lung inflammatory responses in patients with severe pneumonia, with Drug_discovery a tendency to decrease mortality. Confalonieri et al.