Table of Contents
- Clinical trial overview
- Infections and patient groups studied
- Trial designs, phases, and sizes
- Main outcomes being measured
- What these studies mean for patients
- Key terms explained
Clinical trial overview
The available studies investigate Imipenem in real clinical research settings, mostly for serious infections in adults.[1] These trials do not focus on the drug itself as a textbook topic; they study how it performs in patients, often compared with other antibiotics or treatment strategies.[1][2]
Most of the listed studies are Phase 3 trials, which means they test treatment effects in larger groups and compare outcomes between study arms.[1][1] One study is Phase 2 and looks at treatment choices for Mycobacterium abscessus lung disease.[3]
Infections and patient groups studied
The trials cover several infection types, showing that Imipenem is being studied in many severe or hard-to-treat situations.[1][2][1]
Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia: one Phase 3 study compares an Imipenem-based treatment with another regimen in adults with these lung infections caused by Gram-negative bacteria.[1]
Febrile neutropenia: one Phase 3 study in hematology patients asks whether stopping antibiotics after 3 days is as safe as longer treatment. Imipenem is one of the antibiotics used in the study.[4]
Pyogenic liver abscess: one Phase 3 non-inferiority trial studies whether 3 weeks of antibiotic therapy after drainage is not worse than 6 weeks. Imipenem/cilastatin/relebactam is one of the treatment options listed.[5]
Febrile urinary tract infection: one Phase 2 trial studies oral follow-up treatment after initial therapy, and Imipenem/cilastatin is listed among the comparator treatments.[6]
Severe infections: one Phase 3 study tests a strategy that uses procalcitonin guidance and molecular-guided diagnosis to reduce unnecessary broad-spectrum antibiotic days; Imipenem is among the antibiotics used in the trial.[7]
Mycobacterium abscessus pulmonary disease: one Phase 2 study looks at the best treatment for this lung disease and includes Imipenem in the treatment options.[3]
Complicated urinary tract infection, acute pyelonephritis, hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, and complicated intra-abdominal infection: one Phase 3 study in adults with carbapenem-resistant Enterobacterales includes an Imipenem/cilastatin/relebactam arm.[2]
Critically ill patients with serious infections: one Phase 3 study measures antibiotic blood levels, and Imipenem/cilastatin/relebactam is among the antibiotics studied.[8]
Trial designs, phases, and sizes
The studies use different designs, including randomized trials, comparative trials, non-inferiority trials, and interventional studies.[1][2][1][4][5][6][7][8]
Enrollment sizes range from 150 patients in one completed trial to 1250 patients in the intensive care study, so the research includes both moderate and very large groups.[2][8] The largest studies are designed to give stronger evidence about how well treatment works in real patient groups.[8]
Some studies compare Imipenem-containing regimens with other antibiotic options, while others use it as one of several possible treatments in a broader strategy.[1][4][7]
Main outcomes being measured
The main outcomes are focused on patient benefit, treatment success, and safety.[1][2][1][3][4][5][6][7][8]
Day 14 all-cause mortality: one pneumonia trial measures death from any cause by day 14 after randomization.[1]
Broad-spectrum antibiotic days: one severe infection trial measures how many days patients receive broad-spectrum antibiotics, with the goal of reducing unnecessary exposure.[7]
Overall treatment success at TOC: one trial in carbapenem-resistant Enterobacterales infections uses a composite endpoint, meaning it combines several infection-specific results into one main measure.[2]
Microbiological clearance: the Mycobacterium abscessus study checks whether cultures become negative after treatment, which means the germ is no longer found in sputum or bronchoalveolar lavage samples.[3]
Serious medical complications: the febrile neutropenia study checks for death, ICU admission, or septic shock needing vasopressive therapy within 42 days.[4]
Treatment failure after drainage: the liver abscess study measures whether patients have treatment failure between the end of treatment and week 12 after drainage.[5]
Clinical response at test of cure: the febrile UTI study looks for no new healthcare contacts or extra antibiotics, fever resolution, and symptom improvement 7 days after treatment ends.[6]
Antibiotic plasma target: the intensive care study measures whether blood concentrations reach the planned target levels for each antibiotic.[8]
What these studies mean for patients
These trials show that Imipenem is being studied in patients who are often very sick and may have infections that are difficult to treat.[1][2][1][4][5][7][8]
Some studies ask whether a shorter antibiotic course is enough, while others compare different treatment combinations or look for the best way to guide therapy.[4][5][7]
In simple terms, the research is trying to find out which treatment plan gives the best balance between helping the infection and avoiding unnecessary antibiotic use.[4][7]
Key terms explained
Non-inferiority means a study is checking whether a shorter or different treatment is not meaningfully worse than the standard approach.[5][6] Composite endpoint means several results are combined into one main outcome, such as treatment success across many infection types.[2]
Modified Intent-to-Treat population is the group used for the main analysis after applying study rules about who counts in the final results.[1] Test of cure is a follow-up visit or time point used to judge whether the infection has responded to treatment.[2][6]
CTCAE grades are a standard way to rate how severe side effects are, from mild to very serious.[3] Procalcitonin guidance means treatment decisions are guided by a blood marker linked to infection activity.[7]
