In short
Eravacycline is a tetracycline antibiotic authorised in the European Union under the trade name Xerava for treating complicated intra-abdominal infections in adults and adolescents from 12 years of age who weigh at least 50 kg. It works by blocking bacterial protein production, which kills the bacteria causing the infection.
Key points
- Eravacycline is a tetracycline antibiotic authorised in the EU as Xerava for complicated intra-abdominal infections.
- One Phase 3 trial is investigating eravacycline in liver transplant patients colonised with carbapenemase-producing Enterobacterales.
- The trial plans to enrol 168 participants and is currently authorised.
- The study compares targeted peri-operative prophylaxis with standard prophylaxis to reduce early CPE infection after liver transplantation.
- Eravacycline is given by intravenous infusion over one hour, once every 12 hours.
What is eravacycline?
Eravacycline is the active substance in Xerava, a medicine authorised for use in the European Union. It belongs to a group of antibiotics called tetracyclines. Tetracyclines are a class of antibiotics that act against a broad range of bacteria. Xerava is authorised to treat complicated intra-abdominal infections (cIAI) in adolescents from 12 years of age who weigh at least 50 kg and in adults. A complicated infection means that the infection is difficult to treat because it has spread within the abdominal space.
How does eravacycline work?
Eravacycline works by attaching to and blocking part of the cell machinery in bacteria that is involved in making proteins. This leads to the death of the bacteria causing the infection. Antibiotics such as eravacycline will not work for colds, flu, or other viral infections.
Which conditions is eravacycline used or studied for?
- Complicated intra-abdominal infections (cIAI) — infections of the abdomen that have spread within the abdominal space and are difficult to treat. Eravacycline is authorised in the EU for this use in adults and adolescents from 12 years who weigh at least 50 kg.
- Infections in liver transplant patients colonised with carbapenemase-producing Enterobacterales (CPE) — one Phase 3 trial is studying eravacycline as part of a targeted antibiotic strategy to prevent early CPE infection after liver transplantation.
How is eravacycline given?
Eravacycline is given by infusion (drip) into a vein over one hour. It is given once every 12 hours for at least 4 days and up to 14 days. The dose depends on the patient's weight, and may be increased if the patient is also taking a type of medicine called a strong CYP3A4 inducer. Eravacycline comes as a powder to be mixed with fluid and injected into a vein. It may be given in a hospital or used at home. In the Phase 3 trial, eravacycline is given as Xerava 50 mg powder for concentrate for solution for infusion at a dose of 2 mg per kilogram by intravenous infusion.
What do the clinical trials show?
One trial is registered in the EU Clinical Trials Information System for eravacycline in the setting of liver transplantation. The trial is a Phase 3 study with a planned enrollment of 168 participants and is currently authorised. It uses a stepped-wedge cluster randomisation design, meaning that the intervention is introduced at different times across participating centres. The study compares targeted peri-operative prophylaxis (T-PAP) with standard peri-operative prophylaxis (S-PAP) in patients colonised with carbapenemase-producing Enterobacterales who are undergoing liver transplantation. The primary outcome is the effect of T-PAP over S-PAP on the rate of CPE infection in the first two weeks after liver transplantation. Eravacycline is one of several antibiotics included in the targeted prophylaxis arm of the study.
What side effects are known?
The supplementary sources provided do not contain a detailed list of side effects for eravacycline. For complete information on side effects, the European public assessment report (EPAR) for Xerava and the package leaflet are the reference documents.