Europas førende søgning efter kliniske forsøg

Amoxicillin Sodium

Clinical trials are studying Amoxicillin Sodium in different infection settings to see how well it works and how safe it is. The trials include adults, children, pregnant women, and critically ill patients. They mainly look at treatment success, infection control, and shorter or longer antibiotic courses.

Table of Contents

Overview of the Amoxicillin Sodium trials

These trials study Amoxicillin Sodium in different infection settings, mostly as part of treatment plans for bacterial infections. The research asks practical questions such as whether a shorter course works as well as a longer one, and whether treatment can be guided by the patient’s clinical response.[1][4]

Several studies compare Amoxicillin Sodium with other antibiotics or with other treatment strategies. The trial data also show that Amoxicillin Sodium is sometimes used together with other drugs, depending on the infection being studied.[1][5]

Conditions being studied

The trials cover a wide range of infections and patient groups. These include infection of osteosynthesis material after long bone fracture, febrile urinary tract infection, enterococcal bacteremia, erysipelas of the lower limbs, community-acquired pneumonia, ventilator-associated pneumonia, catheter-related bloodstream infection, and systemic infections in critically ill children.[1][3][4][5][6][8]

Other studies include adults with chemotherapy-related fever, children with chronic pouchitis, pregnant women with premature rupture of membranes, elderly patients hospitalized for viral infection, and patients with periprosthetic joint infection or medication-related osteonecrosis of the jaw.[2][3][6][5][7][9][10]

Who can take part

The target populations differ by study. Some trials are for adults only, such as adults with lower-limb erysipelas, community-acquired pneumonia, or haematology patients expected to develop short-lasting neutropenia, which means a low white blood cell count for less than 7 days.[4][5][3]

Other studies include children, such as pediatric chronic pouchitis and critically ill children with systemic infections. Some trials also include special groups like pregnant women with premature rupture of membranes, older adults with viral infections, and young adults and adults treated with CAR-T cell therapy for blood cancers.[3][5][7][8][10]

In several studies, patients must have a specific infection confirmed or strongly suspected, such as infection with Escherichia coli in febrile urinary tract infection or uncomplicated bacteremia caused by E. faecalis or E. faecium.[3][4]

Trial phases and study designs

Most Amoxicillin Sodium trials in the source data are Phase 3 studies, which usually compare treatments in larger groups of patients. There is also a smaller Phase 2 study on febrile urinary tract infection, and some studies are marked as low-intervention, meaning the treatment plan is closer to usual care and the study mainly observes outcomes.[1][4][3][5][5]

Several trials are randomized, which means patients are assigned by chance to one treatment group or another. Some are open-label, which means both the study team and the patient know which treatment is given.[1][5][6]

Some studies are non-inferiority trials. This means the researchers want to show that a shorter or simpler treatment is not meaningfully worse than the standard treatment.[4][3][5]

Main outcomes and endpoints

The main outcomes focus on how well the infection improves and whether treatment can be safely shortened or optimized. Common endpoints include clinical success, clinical cure, remission, fever control, disappearance of infection signs, and no need to change antibiotics.[1][4][3][4][5]

Some studies measure more specific results, such as the proportion of patients with vaginal delivery within 24 hours, the number of days alive without antibiotics, or survival at day 28. Other trials measure whether blood levels of antibiotics reach a target level, or whether patients recover without relapse.[5][6][7][8]

A few studies also include patient-reported outcomes, such as satisfaction, quality of life, or health-related costs. In the periprosthetic joint infection study, the main endpoint is a cost-utility analysis, which compares treatment costs with quality-adjusted life years, a way to combine length and quality of life.[6][9]

Selected trial highlights

Osteosynthesis material infection after long bone fracture. This Phase 3 study compares different antimicrobial treatment durations after surgical debridement, either with the implant kept in place or removed. The main outcome looks at clinical failure and fracture healing using the REBORNE scale.[1]

Febrile urinary tract infection. This Phase 2 multicenter trial studies whether oral step-down treatment with pivmecillinam is not worse than standard care after initial treatment. The main endpoint is clinical response at the test-of-cure visit 7 days after treatment ends.[3]

Uncomplicated enterococcal bacteremia. This Phase 3 trial compares 7-day and 14-day antibiotic regimens. The main endpoint is clinical success at test of cure in the intention-to-treat population, meaning all enrolled patients are considered in the analysis as planned.[4]

Lower-limb erysipelas. This Phase 3 study tests whether a short 5-day course is not worse than the usual 10-day course. The main endpoint is complete remission at day 12 plus or minus 2 days, based on fever, skin symptoms, and no extra antibiotics for cellulitis.[5]

Community-acquired pneumonia. This Phase 3 trial in adults treated in the community studies stopping antibiotics based on clinical response rather than a fixed duration. The main endpoint is cure at day 15 after treatment starts.[6]

Critically ill children with systemic infections. This Phase 3 study looks at early model-informed precision dosing of beta-lactam antibiotics, including Amoxicillin, and asks whether more children reach the therapeutic target at 48 hours.[8]

What the results may mean for patients

These studies are not about the basic science of Amoxicillin Sodium. They are about how it is used in real patients with different infections, and whether certain treatment plans work better, last shorter, or reduce antibiotic use.[1][4][6]

For patients, the most important message is that the trials aim to improve infection care by testing treatment length, treatment choice, and treatment response in specific groups. The results may help doctors choose the best plan for a given infection and patient type.[1][3][5]

Trial ID Phase Condition studied Status Enrollment
NCT05294796 Phase 3 Infection of osteosynthesis material after long bone fracture Authorised 364
2025-520995-24-00 Phase 3 Chemotherapy-induced fever in adult haematology patients Authorised 1526
2023-503447-33-00 Phase 2 Febrile urinary tract infection Authorised 560
NCT05394298 Phase 3 Uncomplicated enterococcal bacteremia Authorised 284
NCT07104552 Phase 3 Lower-limb erysipelas in adults Authorised 656
NCT04166110 Phase 3 Community-acquired pneumonia Authorised 500
NCT05696093 Phase 3 Ventilator-associated pneumonia Completed 628
NCT05117398 Phase 3 Catheter-related bloodstream infections due to Staphylococcus aureus Authorised 406
NCT02735707 Phase 3 Acute respiratory tract infection / community-acquired pneumonia platform Authorised 3471
NCT2024-516447-12-00 Phase 3 Systemic infections in critically ill children Authorised 58

FAQ

  • What kinds of studies include Amoxicillin Sodium? Most studies are interventional trials, which means patients receive a planned treatment and the results are compared. The trials look at infection treatment, treatment length, and how well patients recover.
  • Which patients are being studied? The trials include many groups, such as adults with bone, joint, lung, urinary, or skin infections, children with pouchitis or severe infections, pregnant women with premature rupture of membranes, and critically ill patients. Some studies also include older adults and people with blood infections.
  • What phases are the Amoxicillin Sodium trials in? The trials are mainly in Phase 2 and Phase 3, with some low-intervention studies. Phase 2 usually looks at early proof of benefit, while Phase 3 compares treatments in larger groups.
  • What outcomes do these trials measure? Common outcomes include clinical cure, remission, fever control, infection signs, relapse, and days without antibiotics. Some studies also measure quality of life, cost, or drug levels in the blood.
  • Is Amoxicillin Sodium always the main treatment being tested? No. In some trials it is one of several treatment options, while in others it is part of a comparison group or background treatment. The main goal is to see which treatment plan works best for the studied infection.

Igangværende kliniske forsøg for Amoxicillin Sodium

  • Sammenligning af dalbavancin med standardantibiotisk behandling hos patienter med proteseledsinfektion – et randomiseret studie af effekt og livskvalitet

    Rekrutterer

    1 1 1 1
    Undersøgte lægemidler:
    Danmark

  • Undersøgelse af pivmecillinam som oral behandling sammenlignet med standardbehandling hos patienter med Escherichia coli-forårsaget febril urinvejsinfektion

    Rekrutterer

    1 1 1
    Undersøgte lægemidler:
    Norge Sverige

  • Sammenligning af bakterievacciner og antibiotika til behandling af infektioner i hofte- eller knæproteser

    Rekrutterer

    1 1 1 1
    Undersøgte lægemidler:
    Spanien

  • Kan tidlig stop af antibiotika gavne ældre patienter indlagt med virusinfektion?

    Rekrutterer

    1 1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Frankrig

  • Undersøgelse af GNT0003 og imlifidase hos voksne med svært Crigler-Najjar syndrom og eksisterende anti-AAV8 antistoffer

    Rekrutterer

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Frankrig

  • Sammenligning af engangsdosis dalbavancin med standardbehandling ved blodforgiftning fra kateter med Staphylococcus aureus-bakterier

    Rekrutterer

    1 1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Frankrig

  • Test af skræddersyet antibiotika-behandling ved svær KOL-forværring ved hjælp af PCR-test og procalcitonin

    Rekrutterer

    1 1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Frankrig

  • Undersøgelse af præcis dosering af beta-laktam antibiotika (amoxicillin-klavulansyre, piperacillin-tazobactam og meropenem) hos kritisk syge børn med systemiske infektioner

    Rekrutterer

    1 1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Belgien

  • Test af forskellige behandlinger mod lungebetændelse hos hospitalsindlagte patienter

    Rekrutterer

    1 1 1 1
    Undersøgte lægemidler:
    Belgien Kroatien Tjekkiet Estland Frankrig Tyskland +7

  • Sammenligning af kort og lang antibiotisk behandling ved infektion i metalimplantater efter knoglebrud

    Rekrutterer

    1 1 1 1
    Undersøgte lægemidler:
    Spanien

Ordliste

  • Interventional trial: A study where researchers give one or more planned treatments and then measure the results.
  • Phase 2: An early study phase that looks at whether a treatment seems to work and whether it appears acceptable in a smaller group.
  • Phase 3: A larger study phase that compares treatments more carefully to see which works better or is not worse than another option.
  • Non-inferiority: A study goal showing that one treatment is not meaningfully worse than another standard treatment.
  • Clinical cure: A patient no longer has the main signs and symptoms of the infection being studied.
  • Remission: A clear improvement or disappearance of disease signs, often used when symptoms become much better or go away.
  • Primary outcome: The main result the researchers want to measure.
  • Enrollment: The number of people planned to take part in the study.
  • Debridement: An operation to clean infected or damaged tissue.
  • Implant retention: Keeping an implanted device in place during treatment instead of removing it.
  • Relapse: When the infection comes back after it seemed better.
  • Quality-adjusted life years (QALYs): A way to measure both how long people live and how good their health is during that time.

Referencer

  1. https://kliniske-forsoeg.dk/forsog/sammenligning-af-kort-og-lang-antibiotisk-behandling-ved-infektion-i-metalimplantater-efter-knoglebrud/
  2. https://clinicaltrials.gov/study/2025-520995-24-00
  3. https://clinicaltrials.gov/study/2023-503447-33-00
  4. https://kliniske-forsoeg.dk/forsog/sammenligning-af-7-versus-14-dages-antibiotika-til-behandling-af-ukompliceret-enterokokinfektion-i-blodet/
  5. https://kliniske-forsoeg.dk/forsog/sammenligning-af-kort-og-normal-behandlingstid-med-amoxicillin-mod-rosen-hudinfektion-pa-benene/
  6. https://kliniske-forsoeg.dk/forsog/undersoegelse-af-individualiseret-antibiotisk-behandlingsvarighed-hos-voksne-med-samfundserhvervet-lungebetaendelse-med-kombinationsbehandling-af-antibiotika/
  7. https://clinicaltrials.gov/study/2024-515695-13-00
  8. https://clinicaltrials.gov/study/2024-516447-12-00
  9. https://clinicaltrials.gov/study/2025-522088-13-00
  10. https://clinicaltrials.gov/study/2025-521571-30-00