Erythromycin in Septic Patients: Immunomodulatory Role and Clinical Impact

• Status: Not yet recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

In sepsis and septic shock, the host response is characterized by a complex of immune-inflammatory reactions; triggered and activated by microbial components. These reactions are controlled by a balance of pro-inflammatory cytokines and anti-inflammatory cytokines. The imbalance of this immune response is a source of organ dysfunction; major prognostic factor during septic condition. This pretext has created the need for therapies aimed to modulate the overstated of host response. During the past 2 decades, macrolide molecules proved interest to be immunomodulatory agents; due beyond their antibacterial activity. Their regulatory role in the production of cytokines was demonstrated in the management of severe acute community pneumonia.

The investigators hypothesize that the adjunction of macrolides to standard therapy in patients with sepsis or septic shock is associated to a favorable immunomodulatory and clinical effects.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tunis University
• Treatments: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate

Criteria

Inclusion Criteria:

• a patient in whom the diagnosis of sepsis or septic shock is diagnosed (According to the definitions updated by the sepsis 3 consensus in 2016)

Exclusion Criteria:

• Macrolide use for another indication.

• Known allergy to macrolides.

• A corrected QT prolonged (> 440 ms for man and 460 ms for woman) or taking drugs with an increased risk of QT prolongation.

• QT prolongation attributed to erythromycin

• Underlying dysimmunity (unbalanced diabetes, autoimmune disease, etc.)

• Pregnant or breastfeeding woman.

• Death or discharge while participating in the protocol (day 0 to day 6)

• Non-compliance with the protocol