Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000708257
Ethics application status
Approved
Date submitted
28/07/2009
Date registered
17/08/2009
Date last updated
18/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects
Scientific title
A Randomized Open Label Study Comparing the Efficacy, Safety and Tolerability of Oral Administration of Amantadine and Ribavirin and Oseltamivir Versus Oseltamivir to Influenza A Virus Infected Immunocompromised Subjects.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza A 237213 0
Immune compromised 237214 0
Condition category
Condition code
Infection 237531 237531 0 0
Other infectious diseases
Inflammatory and Immune System 239781 239781 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Amantadine treatment for 10 days,
Ribavirin treatment for 10 days and
Oseltamivir treatment for 10 days.
Potential subjects will be advised of treatment schedule and dosage at time of consent.
Intervention code [1] 236912 0
Treatment: Drugs
Comparator / control treatment
Oseltamivir treatment lasting for 10 days. Potential subjects will be advised of treatment schedule and dosage at time of consent.
Control group
Active

Outcomes
Primary outcome [1] 238344 0
To assess the antiviral efficacy of triple combination antiviral drug (TCAD) therapy (ie. amantadine and ribavirin and oseltamivir) compared to oseltamivir in immunocompromised subjects diagnosed with Influenza A. The primary endpoint is clearing of viral shedding as determined by quantitative Reverse Transcription-Polymerase Chain Reaction (RT-PCR) using nasalpharyngeal swabs.
Timepoint [1] 238344 0
Viral load measured at Baseline, Day 2, Day 4, Day 6, Day 8, Day 10, Day 15, Day 20.
Secondary outcome [1] 244752 0
Time to alleviation of influenza clinical symptoms based on symptom survey.
Timepoint [1] 244752 0
Baseline, Day 2, Day 4, Day 6, Day 8, Day 10, Day 15, Day 20, Day 38.
Secondary outcome [2] 244753 0
Proportion of subjects who enter with mild to moderate influenza and progress to severe influenza during randomized study treatment. Severe influenza as defined by the following.
Oxygen saturation less than or equal to 92% on room air or
Severe Tachypnea (respiratory rate greater than or equal to 30 for all ages greater than or equal to 12 years)
New Infiltrate on chest X-ray (or any infiltrate if no prior chest X-ray or not known)
Timepoint [2] 244753 0
Baseline, Day 2, Day 4, Day 6, Day 8, Day 10, Day 15, Day 20, Day 38.
Secondary outcome [3] 244758 0
Proportion of subjects with a treatment-sensitive influenza A strain at baseline who develop a resistant strain during treatment, as measured by in vitro and genotypic assays.
Timepoint [3] 244758 0
Baseline, Day 2, Day 4, Day 6, Day 8, Day 10, Day 15, Day 20.
Secondary outcome [4] 244759 0
Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs) as measured through study physical assessment and laboratory analyses.
Timepoint [4] 244759 0
Baseline, Day 2, Day 4, Day 6, Day 8, Day 10, Day 15, Day 20, Day 38.

Eligibility
Key inclusion criteria
Immunocompromised as defined by one of either: recent solid organ or hematopoietic cell transplantation, chronic Graft Versus Host Disease (GVHD) requiring systemic immunosuppression, taking at least 2 immunosuppressants, undergoing chemotherapy, taking high dose corticosteroids or Human Immunodeficiency Virus (HIV) positive.

Clinical diagnosis of Influenza A infection (mild.moderate or severe)

Onset of illness no more than 3 days prior to study entry.

Subjects (Male and Female) agree to use contraception through 24 weeks after last dose.
Minimum age
1 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of more than 2 doses of antiviral influenza medications since onset of symptoms

Critically ill

Creatinine Clearance less than 30 mL/min

Known genetic hemoglobinopathy

Presence of suspected or diagnosed non influenza infection requiring treatment.

Pschyatric or cognitive illness or recreational drug/alcohol use that would affect patient safety and compliance.

Documented non-influenza viral infection, including respiratory syncytial virus or Influenza B

Women who are pregnant, who are attempting to become pregnant, or who are breast-feeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
125
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1884 0
2145
Recruitment postcode(s) [2] 1885 0
3004
Recruitment postcode(s) [3] 1886 0
2010
Recruitment postcode(s) [4] 1887 0
4029
Recruitment postcode(s) [5] 1888 0
3050

Funding & Sponsors
Funding source category [1] 237310 0
Commercial sector/Industry
Name [1] 237310 0
Adamas Pharmaceuticals, Inc.
Country [1] 237310 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Adamas Pharmaceuticals, Inc
Address
1900 Powell Street, Suite 1050, Emeryville, CA 94608
Country
United States of America
Secondary sponsor category [1] 236795 0
Commercial sector/Industry
Name [1] 236795 0
PPD Australia Pty Ltd.
Address [1] 236795 0
Level 9, 5 Queens Road, Melbourne VIC 3004
Country [1] 236795 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29880 0
Address 29880 0
Country 29880 0
Phone 29880 0
Fax 29880 0
Email 29880 0
Contact person for public queries
Name 13127 0
Caterina Foca
Address 13127 0
Level 9, 5 Queens Road, Melbourne VIC 3004
Country 13127 0
Australia
Phone 13127 0
+613 9804 5211
Fax 13127 0
Email 13127 0
Caterina.Foca@ppdi.com
Contact person for scientific queries
Name 4055 0
Caterina Foca
Address 4055 0
Level 9, 5 Queens Road, Melbourne VIC 3004
Country 4055 0
Australia
Phone 4055 0
+613 9804 5211
Fax 4055 0
Email 4055 0
Caterina.Foca@ppdi.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.