Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
NCT ID:
NCT04816968
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 to 90 years.
* Ability to understand and sign informed consent.
* Treatment infection responsive to Cefepime, Meropenem or Piperacillin / Tazobactam, Vancomycin.
* Absence of allergies to Cefepime, Meropenem or Piperacillin / Tazobactam, Vancomycin.
* Evidence of clinical response to treatment with Cefepime, Meropenem or Piperacillin / Tazobactam, Vancomycin and at least 3 days of apyrexia with current infusion antibiotic therapy.
* Good tolerance to ongoing antibiotic treatment with Cefepime, Meropenem or Piperacillin / Tazobactam, Vancomycin.
Exclusion Criteria:
* Inability for any reason (e.g. absence of caregiver) to manage the elastomeric pump and access the hospital on a daily basis.
* Lack of adequate venous access.
* Inability to hydrate themselves properly orally.
* Infection involving the central nervous system.
* Creatinine\> 2 mg / dL.
* Neutrophil granulocytes ≤ 1000 / µL.
* Platelets ≤ 20000 / µL.
* "aspartate amino transferase" and "alanine amino transferase" \> 100 U / L.
* Bilirubin\> 3 mg / dL.
* Presence of any comorbidities that, in the opinion of the physician, could compromise the safe execution of antibiotic home continuous infusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04816968
Study Brief:
Protocol Section:
NCT04816968