Statistical analysis
A safety evaluation will be performed in all the patients who have received at least one study treatment drug, independent of reaching the microbiological diagnosis.The efficacy evaluation will be performed in every patient who receive at least one study treatment drug, per MITT. The primary efficacy will first be valued by means of comparison of mortality at 28 days, and secondary variables of efficacy will be valued by means of clinical and microbiological cure.
The clinical evaluation by modified intention to treat (MITT) will be realized in the population that fulfills the inclusion criteria and receives at least one dose of thestudy drugs. The clinically appraisable population will include those that fulfill the inclusion criteria, who have received the intravenous treatment and with evaluation response data available at the end of the treatment.