In short
Clinical trials are investigating Mecillinam in adults with Gram-negative bacteremia, a serious bloodstream infection. These studies look at whether shorter antibiotic treatment can be effective and safe, especially in hospitalized, immunocompetent adults with a urinary tract source of infection.
Key points
- Clinical trials investigating Mecillinam are looking at treatment for Gram-negative bacteremia, especially cases linked to a urinary tract source of infection. The main study is a Phase 3 interventional trial in hospitalized, immunocompetent adults. It compares a shorter antibiotic course of 5 days with 7 days or more of treatment. The main outcome is 90-day survival without clinical or microbiological failure. The trial is authorised and plans to enroll 380 participants.
Trial overview
The main clinical trial in the data is Short course antibiotic treatment of Gram-negative bacteremia, a multicenter, randomized, non-blinded, non-inferiority interventional study.
It is a Phase 3 trial and is currently Authorised.
The study looks at whether a shorter antibiotic duration can be used for Gram-negative bacteremia with a urinary tract source of infection.
Who is being studied
The target group is hospitalized, immunocompetent adults.
Immunocompetent means the person has a working immune system, which is the body's defense against infection.
The condition studied is Gram-negative bacteremia, which means bacteria are present in the blood.
The trial focuses on cases where the infection has a urinary tract source, meaning it starts in the urinary system and spreads to the blood.
Trial design and treatment groups
This is a randomized study, so participants are assigned to treatment groups by chance.
It is also non-blinded, which means both the researchers and the participants know which treatment is being given.
The study compares shortened antibiotic duration of 5 days with 7 days or more of antibiotic treatment.
The intervention list includes Mecillinam as Selexid in oral and injection forms, along with several other antibiotics used in the study arms.
What the trial measures
The main outcome is 90-day survival without clinical or microbiological failure to treatment.
Clinical failure means the signs or symptoms show the treatment did not work well enough.
Microbiological failure means tests still show the bacteria are not controlled or have not cleared as expected.
This outcome helps researchers see both survival and whether the infection is fully controlled after treatment.
Trial status and size
The trial is listed as Authorised.
The planned enrollment is 380 participants.
Because the study is multicenter, it is designed to collect data from more than one study site.