Table of Contents
- Overview of the trials
- Gram-negative bloodstream infection study
- Infectious endocarditis study
- Bone implant infection study
- Appendicitis study in children and teenagers
- Main outcomes and what they mean
- Who the studies are designed for
Overview of the trials
The trial records show Ampicillin being studied in infection-focused research, not as a general drug profile, but as part of treatment plans being tested in real patients.[1][3][4][2]
Most of the studies are Phase 3 trials, which usually means the treatment is being tested in larger groups to learn how well it works and how safe it is in the studied setting.[1][3][4] One study is listed as Low Intervention, which means the study uses routine treatment choices rather than a highly experimental approach.[2]
Gram-negative bloodstream infection study
NCT04291768 is a multicenter, randomized, non-blinded, non-inferiority interventional study in hospitalized immunocompetent adults with Gram-negative Bacteremia and a urinary tract source of infection.[1]
The study compares a shortened antibiotic duration of 5 days with treatment lasting 7 days or more, and Ampicillin is one of the antibiotics listed in the treatment options.[1]
The main outcome is 90-day survival without clinical or microbiological failure, which means the study checks whether patients are alive and whether the infection has not clearly come back or failed to clear after treatment.[1]
Infectious endocarditis study
The study with ID 2023-507652-76-00 looks at accelerated treatment for infectious endocarditis, which is an infection of the inner lining of the heart.[2]
It focuses on left-sided endocarditis caused by Staphylococcus aureus, Enterococcus faecalis, or streptococci, and Ampicillin appears in the list of study drugs used in the treatment plan.[2]
The study is designed to see whether a shorter course of antibiotics is safe and effective, and its combined primary outcome includes death, septic embolization, bacteremia with the same microorganism, and heart surgery not planned at randomization within 6 months.[2]
Bone implant infection study
NCT05294796 is a Phase 3 pragmatic multicenter open-label randomized trial in patients with infection of osteosynthesis material after long bone fractures.[3]
These patients are treated after surgery called debridement, either with implant retention or with removal of the material, and Ampicillin is listed among the antimicrobial treatments used in the study.[3]
The study asks whether a short treatment course works as well as a longer one after surgery, and the primary outcome looks for clinical failure signs such as symptoms not going away, new infection signs, need to stop or change antibiotics, culture results during surgery, and the REBORNE fracture consolidation scale.[3]
Appendicitis study in children and teenagers
The study with ID 2025-520496-19-00 is a Phase 3 trial in children aged 7 to 18 with acute non-complicated appendicitis.[4]
It studies conservative treatment, which means treating without surgery in selected cases, and it includes Ampicillin as Pamecil 1 g powder for solution for injection or infusion among the listed treatments.[4]
The brief summary says the study aims to assess clinical and economic efficiency, improve early diagnosis criteria, and evaluate cost-efficiency, with treatment plans including 3 days of inpatient treatment and 7 days of outpatient treatment.[4]
Main outcomes and what they mean
Across these studies, the main outcomes focus on whether treatment works and whether infection returns or causes serious problems.[1][2][3]
Survival: used in the bloodstream infection study to check whether patients are alive after treatment.[1]
Clinical failure: used in the bone implant infection study to see whether symptoms and signs improve or return to baseline.[3]
Microbiological failure: used in the bloodstream infection study to see whether the infection-causing germ is still present or comes back.[1]
Septic embolization: used in the endocarditis study and means infected material may travel through the bloodstream and block another vessel.[2]
Heart surgery not planned at randomization: used in the endocarditis study to measure whether the illness becomes serious enough to need surgery later.[2]
Cost-efficiency: used in the appendicitis study to compare clinical results with the cost of care.[4]
Who the studies are designed for
The trial populations are specific and not broad. One study includes hospitalized immunocompetent adults with urinary-source Gram-negative bacteremia, another includes people with left-sided infectious endocarditis caused by certain bacteria, another includes patients with infection of bone fixation material after long bone fractures, and one includes children and teenagers aged 7 to 18 with uncomplicated appendicitis.[1][2][3][4]
Together, these studies show that Ampicillin is being explored in different infection settings where researchers want to learn whether shorter or more focused treatment plans can still control infection well.[1][2][3][4]
