RECRUITING

Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial studies the effect of baloxavir in combination with oseltamivir in treating severe influenza infection in patients who have previously received a hematopoietic (blood) stem cell transplant or have a hematological malignancy. Baloxavir is an antiviral drug that inhibits the growth of influenza virus, reduces viral load and prevents further influenza infection. Osetamivir is an antiviral drug that blocks enzymes on the surfaces of influenza viruses, interfering with cell release of complete viral particles. Giving baloxavir in combination with oseltamivir may shorten or decrease the intensity of influenza infection compared to oseltamivir alone.

Official Title

Efficacy of Combination Baloxovir and Oseltamivir Therapy in Influenza Infected Immunocompromised Hosts

Quick Facts

Study Start:2021-10-11
Study Completion:2028-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04712539

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Hematopoeitic cell transplant recipients OR hematological malignancy patients
  2. 2. Diagnosed with influenza ⱡ
  3. 3. Evidence of LRTI\* or high risk upper respiratory tract infection (URTI)\*\*
  1. 1. Patient requires mechanical ventilation at time of enrollment
  2. 2. Patient is younger than the age of 12 years old
  3. 3. The patient is unable to tolerate oral therapy
  4. 4. The patient is pregnant at screening ( Positive serum β-HCG (beta-human chorionic gonadotropin) test for women of child-bearing potential).
  5. 5. The patient is on a prohibited medication. These include Influenza antiviral drugs with the exception of oseltamivir and baloxavir (such as peramivir, laninamivir, zanamivir, rimantadine, umifenovir or amantadine) and herbal therapies.
  6. 6. The patient is unable to consent will be excluded

Contacts and Locations

Study Contact

Roy F. Chemaly, MD,MPH
CONTACT
713-792-6830
rfchemaly@mdanderson.org

Principal Investigator

Roy F Chemaly, MD,MPH
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Roy F Chemaly, MD,MPH, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-11
Study Completion Date2028-02-28

Study Record Updates

Study Start Date2021-10-11
Study Completion Date2028-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Influenza