Table of Contents
- Trial overview
- Conditions and patient groups
- Trial phases and study designs
- What the trials measure
- Study details by trial
- Key patient points
Trial overview
The clinical trials for Ampicillin Sodium focus on infection treatment and on how the drug is handled in the body.[1] The studies include both treatment trials and pharmacokinetic studies, which means studies that measure drug levels in body fluids.[2]
Across the trial data, Ampicillin Sodium appears in studies of community acquired pneumonia, sepsis, enterococcal infections, complicated urinary tract infection, endocarditis, and pregnancy-related conditions.[1][3] One trial also studies Ampicillin in children with an external ventricular drain and measures its levels in cerebrospinal fluid.[2]
Conditions and patient groups
The target populations are different in each study.[1] Some trials include adults treated in the community, some include hospitalised adults, one includes critically ill patients, one includes children, and others include pregnant women.[1][2][3]
- Community acquired pneumonia: adults treated in the community, where the trial checks whether a shorter antibiotic plan based on clinical response works as well as a fixed plan.[1]
- Sepsis: patients with suspected community acquired sepsis, where the trial compares narrow-spectrum therapy with broader antibiotics and checks safety and non-inferior results.[3]
- Enterococcal infections: patients with Enterococcus faecalis infective endocarditis or uncomplicated bacteremia caused by E. faecalis or E. faecium.[4][5]
- Urinary tract infection: patients with febrile or complicated urinary tract infection, including hospitalised adults.[6][7]
- Pregnancy: women with twin pregnancy and women with preterm premature rupture of membranes.[8][9]
Trial phases and study designs
Most of the studies are in Phase 3, which usually means the treatment is being tested in larger groups and compared with other treatment options.[1][3] There is also one Phase 2 trial and one Phase 1 trial.[2][6]
Several studies are described as interventional, meaning the research team assigns the treatment plan and then measures the result.[1][3] Some studies are randomized and open label, which means patients are assigned by chance and both the patient and study team know which treatment is being used.[1]
Some trials are designed as non-inferiority studies, which ask whether one approach works almost as well as another standard approach.[1][4][6] This design is used when a new or different treatment plan may offer practical benefits if it is not meaningfully worse than the standard plan.[1]
What the trials measure
The main outcomes are different depending on the disease being studied.[1] Some trials measure cure or treatment success, while others measure treatment failure, death, kidney injury, pregnancy length, or antibiotic concentrations in the body.[1][2][3]
- Clinical cure is used in urinary tract infection studies and means the symptoms and fever improve without needing extra antibiotic treatment.[6][7]
- Treatment failure is used in endocarditis research and means the infection comes back after treatment ends.[4]
- Death and acute kidney injury are measured in the sepsis trial to compare safety and outcomes between treatment strategies.[3]
- Antibiotic pharmacokinetics are measured in studies of cerebrospinal fluid, pregnancy, and critical illness to see how much antibiotic reaches the target body fluid or blood level.[2][8][10]
- Pregnancy latency in the PROM study means the time from membrane rupture to delivery, with the goal of extending pregnancy beyond 7 days.[9]
Study details by trial
NCT04166110 studies adults with community acquired pneumonia in the community setting.[1] The trial compares an individualized antibiotic duration based on clinical response with a conventional fixed duration, and the main outcome is the percentage of cure at Day 15 after treatment starts.[1]
2024-515791-12-00 is a Phase 1 study in children with an external ventricular drain.[2] It measures Ampicillin levels in cerebrospinal fluid using values such as maximum concentration, time to maximum concentration, area under the concentration-time curve, and half-life.[2]
NCT06712641 is a Phase 3 trial in suspected community acquired sepsis.[3] It compares narrow-spectrum beta-lactam treatment, including Ampicillin, plus gentamicin against broad-spectrum antibiotics, and it measures death and acute kidney injury up to 30 days after randomization.[3]
2024-511719-40-00 studies Enterococcus faecalis infective endocarditis in Phase 3.[4] The trial tests whether continuous infusion Ampicillin-ceftriaxone is not worse than standard treatment, and the main endpoint is confirmed recurrence one year after treatment ends.[4]
NCT05394298 is a Phase 3 trial in uncomplicated bacteremia caused by E. faecalis or E. faecium.[5] It compares 7-day and 14-day treatment plans and measures clinical success at test of cure in the intention-to-treat population.[5]
2024-516232-10-00 is a Phase 3 study in critically ill patients with serious infections.[10] It looks at whether antibiotic blood levels reach planned PK/PD targets, which are exposure goals used to judge whether the drug level is likely to be adequate.[10]
2024-518564-12-00 studies pregnant women with twin pregnancy in Phase 3.[8] The trial measures antibiotic concentration in maternal blood, cord blood, and placenta-related spaces, and it also checks whether twin siblings have different levels.[8]
2024-520237-77-00 is a Phase 3 trial in preterm premature rupture of membranes.[9] It tests whether tailored antibiotic and steroid treatment based on IL-6 in amniotic fluid can prolong pregnancy compared with standard treatment.[9]
2024-520251-24-00 is a Phase 3 study in hospitalised adults with complicated urinary tract infections.[6] It compares pivmecillinam plus one IV gentamicin dose with standard treatment options such as IV Ampicillin plus gentamicin or IV piperacillin/tazobactam, and it measures clinical cure on day 3.[6]
Key patient points
- These trials do not all ask the same question; some focus on treatment success, and others focus on drug levels in the body.[1][2]
- The studies cover a wide range of patients, from children to adults and pregnant women.[2][8]
- Most trials are late-stage studies, so they are designed to compare Ampicillin Sodium-related treatment plans with standard care or other options.[1][4]
- The main results being tracked are practical outcomes like cure, recurrence, survival, safety, and whether enough antibiotic reaches the target site.[3][10]
