In short
Ampicillin Sodium is being studied in clinical trials for different infections and patient groups. These trials look at whether treatment plans are effective, safe, and practical in adults, children, pregnant women, and critically ill patients. Some studies also measure how the drug behaves in the body, such as in blood or cerebrospinal fluid.
Key points
- Clinical trials of Ampicillin Sodium are studying several infection-related conditions, including sepsis, endocarditis, urinary tract infection, pneumonia, and pregnancy-related problems. Most studies are Phase 3, with one Phase 2 study and one Phase 1 study. The target groups include adults, children, pregnant women, and critically ill patients. Some trials compare Ampicillin Sodium with other antibiotics, while others measure drug levels in blood or cerebrospinal fluid. The main outcomes include cure, treatment failure, survival, kidney injury, pregnancy length, and antibiotic exposure in the body.
Trial overview
The clinical trials for Ampicillin Sodium focus on infection treatment and on how the drug is handled in the body. The studies include both treatment trials and pharmacokinetic studies, which means studies that measure drug levels in body fluids.
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. One trial also studies Ampicillin in children with an external ventricular drain and measures its levels in cerebrospinal fluid.
Conditions and patient groups
The target populations are different in each study. 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.
- 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.
- Sepsis: patients with suspected community acquired sepsis, where the trial compares narrow-spectrum therapy with broader antibiotics and checks safety and non-inferior results.
- Enterococcal infections: patients with Enterococcus faecalis infective endocarditis or uncomplicated bacteremia caused by E. faecalis or E. faecium.
- Urinary tract infection: patients with febrile or complicated urinary tract infection, including hospitalised adults.
- Pregnancy: women with twin pregnancy and women with preterm premature rupture of membranes.
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. There is also one Phase 2 trial and one Phase 1 trial.
Several studies are described as interventional, meaning the research team assigns the treatment plan and then measures the result. 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.
Some trials are designed as non-inferiority studies, which ask whether one approach works almost as well as another standard approach. 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.
What the trials measure
The main outcomes are different depending on the disease being studied. Some trials measure cure or treatment success, while others measure treatment failure, death, kidney injury, pregnancy length, or antibiotic concentrations in the body.
- Clinical cure is used in urinary tract infection studies and means the symptoms and fever improve without needing extra antibiotic treatment.
- Treatment failure is used in endocarditis research and means the infection comes back after treatment ends.
- Death and acute kidney injury are measured in the sepsis trial to compare safety and outcomes between treatment strategies.
- 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.
- Pregnancy latency in the PROM study means the time from membrane rupture to delivery, with the goal of extending pregnancy beyond 7 days.
Study details by trial
NCT04166110 studies adults with community acquired pneumonia in the community setting. 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.
2024-515791-12-00 is a Phase 1 study in children with an external ventricular drain. 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.
NCT06712641 is a Phase 3 trial in suspected community acquired sepsis. 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.
2024-511719-40-00 studies Enterococcus faecalis infective endocarditis in Phase 3. 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.
NCT05394298 is a Phase 3 trial in uncomplicated bacteremia caused by E. faecalis or E. faecium. It compares 7-day and 14-day treatment plans and measures clinical success at test of cure in the intention-to-treat population.
2024-516232-10-00 is a Phase 3 study in critically ill patients with serious infections. 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.
2024-518564-12-00 studies pregnant women with twin pregnancy in Phase 3. The trial measures antibiotic concentration in maternal blood, cord blood, and placenta-related spaces, and it also checks whether twin siblings have different levels.
2024-520237-77-00 is a Phase 3 trial in preterm premature rupture of membranes. It tests whether tailored antibiotic and steroid treatment based on IL-6 in amniotic fluid can prolong pregnancy compared with standard treatment.
2024-520251-24-00 is a Phase 3 study in hospitalised adults with complicated urinary tract infections. 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.
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.
- The studies cover a wide range of patients, from children to adults and pregnant women.
- Most trials are late-stage studies, so they are designed to compare Ampicillin Sodium-related treatment plans with standard care or other options.
- The main results being tracked are practical outcomes like cure, recurrence, survival, safety, and whether enough antibiotic reaches the target site.