The evaluation of clinical and laboratory efficacy of four-hour infusion vs. half-hour infusion of Ampicillin-Sulbactam in empiric and definite treatment of patients with sepsis and severe sepsis in the intensive care unit of Namazee and shahid Rajaee hospital in Shiraz.

The evaluation of clinical and laboratory efficacy of four-hour infusion vs. half-hour infusion of Ampicillin-Sulbactam in empiric and definite treatment of patients with sepsis and severe sepsis in the intensive care unit (ICU)

Pragmatic, community based, parallel group, double blind, randomised controlled trial

This study will be conducted in the ICU of Namazee and Rajaee hospital, Shiraz, Iran. The patients with sepsis and severe sepsis will be categorized into two groups by permuted block randomization: 1. Receiving Ampicillin-Sulbactam as a 0.5 hour infusion 2- Receiving Ampicillin-Sulbactam as a 4 hour infusion. Every patient will be determined by a number and the list of numbers of patients in each group will be given to the nurses. The participants, the physicians, the nvestigator and the data collectors will be blinded to the study.

Inclusion criteria: More than 18 years old; Diagnosis of sepsis and severe sepsis based on qSOFA criteria; Taking Ampicillin- Sulbactam at least for three days; Exclusion criteria: Pregnancy; Sensitivity to Ampicillin- Sulbactam; Receiving Ampicillin- Sulbactam more than 24 hours during 1 week before being admitted to the intensive care unit; Patients with GFR<10 ml/min or hemodialysis ; Patients with Pseudomonas, penicillin-resistant staph aureus (MRSA), or stenotrophomonas;

- The patients with sepsis and severe sepsis receiving Ampicillin-Sulbactam as 4 hour infusion - The patients with sepsis and severe sepsis receiving Ampicillin-Sulbactam as 0.5 hour infusion

Clinical cure (resolution of signs and symptoms related to the infection, including hypothermia or hyperthermia, low platelet count, high heart rate, high respiratory rate or low PaCO2, abnormal white blood cell count and positive microbial culture

Method of randomization: Permuted block randomization. Unit of randomization: Individual. Tools used in randomization: computer software.

In this study, the participants, the principle investigator, the physicians and the data collectors are blinded. The patients who are going to receive the drug as short or long infusion, are determined by numbers and these numbers are given to the head nurse and nurses of the ICU.