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Mecillinam

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.

Table of Contents

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.[1]

It is a Phase 3 trial and is currently Authorised.[1]

The study looks at whether a shorter antibiotic duration can be used for Gram-negative bacteremia with a urinary tract source of infection.[1]

Who is being studied

The target group is hospitalized, immunocompetent adults.[1]

Immunocompetent means the person has a working immune system, which is the body’s defense against infection.[1]

The condition studied is Gram-negative bacteremia, which means bacteria are present in the blood.[1]

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.[1]

Trial design and treatment groups

This is a randomized study, so participants are assigned to treatment groups by chance.[1]

It is also non-blinded, which means both the researchers and the participants know which treatment is being given.[1]

The study compares shortened antibiotic duration of 5 days with 7 days or more of antibiotic treatment.[1]

The intervention list includes Mecillinam as Selexid in oral and injection forms, along with several other antibiotics used in the study arms.[1]

What the trial measures

The main outcome is 90-day survival without clinical or microbiological failure to treatment.[1]

Clinical failure means the signs or symptoms show the treatment did not work well enough.[1]

Microbiological failure means tests still show the bacteria are not controlled or have not cleared as expected.[1]

This outcome helps researchers see both survival and whether the infection is fully controlled after treatment.[1]

Trial status and size

The trial is listed as Authorised.[1]

The planned enrollment is 380 participants.[1]

Because the study is multicenter, it is designed to collect data from more than one study site.[1]

Trial ID Phase Condition Studied Status Enrollment
NCT04291768 Phase 3 Gram-negative Bacteremia Authorised 380

FAQ

  • What is being studied in Mecillinam clinical trials? The trial is studying whether a shorter antibiotic course can work well for Gram-negative bacteremia. It compares 5 days of treatment with 7 days or more.
  • Who can take part in these trials? The study focuses on hospitalized, immunocompetent adults. It is for people with Gram-negative bacteremia that comes from a urinary tract source of infection.
  • What phase is the Mecillinam trial? The trial is a Phase 3 study. Phase 3 trials test how well a treatment works and how safe it is in a larger group of people.
  • What condition is being treated in the trial? The trial is for Gram-negative bacteremia. This means bacteria are found in the blood and are part of a group called Gram-negative bacteria.
  • What is the main result being measured? The main result is 90-day survival without clinical or microbiological failure. This means researchers check if people are alive after 90 days and have not had signs that the treatment failed.

Ongoing Clinical Trials on Mecillinam

  • Study on Shortened Antibiotic Treatment for Gram-negative Bacteremia in Hospitalized Adults Using Pivmecillinam Hydrochloride and Drug Combination

    Recruiting

    3 1 1 1
    Investigated drugs:
    Denmark

Glossary

  • Gram-negative bacteremia: A bloodstream infection caused by Gram-negative bacteria. It is a serious infection because the bacteria are in the blood.
  • Urinary tract source of infection: The infection starts in the urinary system, such as the bladder or kidneys, and then spreads to the blood.
  • Immunocompetent: Having a working immune system. The immune system is the body's defense against infection.
  • Hospitalized: Being treated in a hospital instead of at home.
  • Phase 3: A late stage of clinical research that studies how well a treatment works and how safe it is in a larger group.
  • Interventional study: A study where researchers give a treatment and compare results between groups.
  • Non-inferiority: A study design that checks whether a new approach is not worse than the standard treatment by more than a set amount.
  • Primary outcome: The main result researchers plan to measure in a study.
  • Clinical failure: When symptoms or signs show that the treatment did not work as expected.
  • Microbiological failure: When tests still show the bacteria are present or not fully controlled.

References