Rapamycin and Infection-related Illness

Condition(s) studied

Investigational drug(s) / intervention(s)

Observational procedures: Patients at the Hoskinson Health and Wellness Clinic qualifying for treatment with Rapamune (Sirolimus) receive a prescription from their physician during clinic visits as part of their standard health care. This study will evaluate the safety, monitor the adverse reactions and observe the preliminary effectiveness of physician-prescribed medical treatment with oral rapamycin \[Rapamune (Sirolimus)\] in a total of 15 adults, 18 years and older toward preventing and lowering the severity of infectious disease or infection-related illness.

Study summary

Conduct a 6-month observational pilot clinical trial to evaluate the safety, monitor the adverse reactions and observe the preliminary effectiveness of medical treatment with oral rapamycin \[Rapamune (Sirolimus)\] in a total of 15 adults, 18 years and older toward preventing and lowering the severity of infectious disease or infection-related illness.

Rapamune (Sirolimus) is not approved by the United States Food and Drug Administration (FDA) to prevent and lessen the severity of infection-related illness or infectious disease. Rapamune (Sirolimus) is approved by the FDA for other indications.

The main procedures in the study include:

* Blood tests to examine cholesterol, lipids, blood platelet counts, inflammation and infection-related health parameters
* Questionnaires to examine brain function, mental health, symptoms, overall health status and quality of life
* Electrocardiogram (ECG to measure heart function)
* Resting diastolic and systolic blood pressure

Eligibility

Primary outcome measure(s)

• The incidence and severity of infectious disease or infection-related illness — Prior to and 3 and 6 months following the initiation of the observational study
  The Primary Endpoint is the incidence and severity of infectious disease or infection-related illness prior to and 3 and 6 months following the initiation of the observational study measured by: * CBC * WBC * Neutrophils * Lymphocytes * Eosinophils * Basophils * Monocytes * CRP * PCT * ESR * ANC * Incidence of infection-related hospitalizations

Trial sites (1)

Other trials for the same condition