TCAD vs. Monotherapy for Influenza A in Immunocompromised Patients

Inclusion Criteria

• •1. Age ≥7 years, male or female; AND
• •2. Influenza infection (i.e. upper respiratory tract infection)
• •1. Young age (1-6 years) with any influenza severity, proven or probable influenza A (H1N1)(H274Y); OR
• •2. History of asthma; OR
• •3. Older age (≥ 7 years), with no asthma; AND
• •* moderate to severe influenza; AND/OR
• •1\. Able to provide informed consent, or for whom consent may be provided by guardian 2. Immunocompromised, as defined by one of the following:
• •Recent hematopoietic cell transplantation (HCT) (within 2 years, all conditioning regimens, allogeneic, autologous, syngeneic; after 2 years patients with chronic graft-versus-host disease (GVHD) requiring systemic treatment may be included) or solid organ transplantation
• •Patients taking at least 2 immunosuppressants
• •Patients undergoing combination chemotherapy within the past 3 month 3. One or more of the following:
• •Presence of fever at time of screening of ≥ 38.0°C (≥ 100.0°F) taken orally.
• •presence of at least one constitutional symptom (headache, myalgia, malaise, or fatigue) of any severity (mild, moderate, or severe),
• •presence of at least one respiratory symptoms (e.g. cough, or sore throat) of any severity (mild, moderate, or severe),
• •other flu-like symptoms, where the clinician orders a respiratory virus test including influenza A or B 4. Positive test for influenza A (if available) 5. Onset of illness no more than 5 days prior to diagnosis. 6. Females patients of child-bearing age who are capable of conception (i.e. previously have not undergone surgical sterilization) must meet the following criteria:
• •Have been sexually abstinent or have used contraceptive agents (oral contraceptive or other hormonal contraceptives including vaginal rings or transdermal patches, intrauterine device (IUD), or barrier methods including condoms) during the 4 weeks prior to date of screening (3 months prior to enrollment for oral/hormonal contraceptives)
• •Agree to be sexually abstinent or use contraceptive agents (oral contraceptive or other hormonal contraceptives including vaginal rings or transdermal patches, intrauterine device (IUD), or barrier methods including condoms) from the date of screening through 24 weeks after the last dose of study drug