TCAD vs. Monotherapy for Influenza A in Immunocompromised Patients

NCT ID: NCT00867139

Last Updated: 2013-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-01-31

Brief Summary

The purpose of this study is to assess the safety and tolerability of triple combination antiviral drug (TCAD) for use in immunocompromised patients with Influenza A infection, and to gain data on the effectiveness of TCAD

Conditions

Influenza

Keywords

Influenza; Immunocompromised; Antiviral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TCAD-Randomized Arm

TCAD (amantadine hydrocholoride, ribavirin and oseltamivir phosphate)

Group Type: EXPERIMENTAL

TCAD

Intervention Type: DRUG

TCAD (amantadine hydrocholoride, ribavirin and oseltamivir phosphate)

Neuraminidase Monotherapy Arm

Zanamivir or Oseltamivir

Group Type: ACTIVE_COMPARATOR

Zanamivir or Oseltamivir

Intervention Type: DRUG

Zanamivir or Oseltamivir

TCAD Open Label Arm

TCAD for subjects who cannot tolerate or are ineligible to receive zanamivir

Group Type: OTHER

Open label treatment with TCAD

Intervention Type: OTHER

TCAD(amantadine hydrocholoride, ribavirin and oseltamivir phosphate)

Interventions

TCAD

TCAD (amantadine hydrocholoride, ribavirin and oseltamivir phosphate)

Intervention Type: DRUG

Zanamivir or Oseltamivir

Zanamivir or Oseltamivir

Intervention Type: DRUG

Open label treatment with TCAD

TCAD(amantadine hydrocholoride, ribavirin and oseltamivir phosphate)

Intervention Type: OTHER

Other Intervention Names

Symmetrel; Rebetol; Tamiflu; Relenza; Tamiflu; Symmetrel; Rebetol; Tamiflu

Eligibility Criteria

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

Exclusion Criteria

1. Nausea that prevents taking oral medications

2. Use of antiviral influenza medication within 10 days(unless switched from randomized to open-label TCAD). An exception to this exclusion criterion may be made by site investigators for patients admitted after hours who receive one or two initial doses of antiviral influenza medication prior to enrollment.

3. Creatinine clearance (estimated by serum creatinine) less than 30 ml/min

4. Current clinical evidence of a recognized or suspected uncontrolled non-influenza infectious illness with onset prior to screening

5. Known hypersensitivity to amantadine, ribavirin, oseltamivir or zanamivir

6. Women who are pregnant (positive serum or urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding

7. Psychiatric or cognitive illness, or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance

8. Uncontrolled seizure disorder or history of a seizure activity within 12 months prior to study participation

9. Any significant finding in the patient's medical history or physical exam on Day 1 that, in the opinion of the investigator, would affect patient safety or compliance with the dosing schedule

10. Documented Influenza B viral co-infection

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Boeckh

Member, Vaccine and Infectious Disease Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Boeckh, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

Seattle Children's

Seattle, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Countries

United States

References

Seo S, Englund JA, Nguyen JT, Pukrittayakamee S, Lindegardh N, Tarning J, Tambyah PA, Renaud C, Went GT, de Jong MD, Boeckh MJ. Combination therapy with amantadine, oseltamivir and ribavirin for influenza A infection: safety and pharmacokinetics. Antivir Ther. 2013;18(3):377-86. doi: 10.3851/IMP2475. Epub 2012 Dec 21.

Reference Type: RESULT

PMID: 23264438 (View on PubMed)

Other Identifiers

6895

Identifier Type: OTHER

Identifier Source: secondary_id

2323.00

Identifier Type: -

Identifier Source: org_study_id

NCT00865800

Identifier Type: -

Identifier Source: nct_alias