Trial Outcomes & Findings for Intermittent Use of Aerosolized Ribavirin for Treatment of RSV (NCT NCT00500578)

Last Updated: 2012-08-01

Results Overview

Treatment failure defined as progression to pneumonia within 7 days of initial treatment with aerosolized ribavirin. Patients considered as a failure or to have an unfavorable response if there develop signs and symptoms of pneumonia during therapy either evidenced by chest-xray or clinically, meaning they did reach the primary endpoint.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

51 participants

Primary outcome timeframe

6 Years

Results posted on

2012-08-01

Participant Flow

Fifty patients were enrolled between October 2003 and March 2008, either from the outpatient settings or inpatients. Eligible patients were randomized to either Arm 1 (Standard regimen: 6gm over 18 hours every 24 hours) or Arm 2 (Modified regimen: 6gm over 3 hours every 8 hours).

Only one patient was excluded from the trial after enrollment and before starting the intervention because his Chest X-Ray was read later on as positive for infiltrates.

Participant milestones

Participant milestones
Measure	Standard Schedule - Ribavarin Aerosolized Ribavirin 6 gm over 18 hours every 24 hours	Modified Schedule - Ribavarin Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
Overall Study STARTED	18	32
Overall Study COMPLETED	18	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intermittent Use of Aerosolized Ribavirin for Treatment of RSV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Schedule - Ribavarin n=18 Participants Aerosolized Ribavirin 6 gm over 18 hours every 24 hours	Modified Schedule - Ribavarin n=32 Participants Aerosolized Ribavirin 6 gm over 3 hours every 8 hours	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	27 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Age Continuous	47.9 years STANDARD_DEVIATION 11.44 • n=5 Participants	46.7 years STANDARD_DEVIATION 14.35 • n=7 Participants	47.16 years STANDARD_DEVIATION 13.39 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	20 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	32 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Years

Population: The analysis was carried out per protocol. All patients enrolled were included in the final analysis except one patient who was a screen failure.

Outcome measures

Outcome measures
Measure	Standard Schedule - Ribavarin n=18 Participants Aerosolized Ribavirin 6 gm over 18 hours every 24 hours	Modified Schedule - Ribavarin n=32 Participants Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
Occurrences of Pneumonia	4 Participants	3 Participants

Adverse Events

Standard Schedule - Ribavarin

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Modified Schedule - Ribavarin

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard Schedule - Ribavarin n=18 participants at risk Aerosolized Ribavirin 6 gm over 18 hours every 24 hours	Modified Schedule - Ribavarin n=32 participants at risk Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
Gastrointestinal disorders Diarrhea	5.6% 1/18 • Number of events 1 • 6 Years	12.5% 4/32 • Number of events 6 • 6 Years
Renal and urinary disorders Bladder Spasm	0.00% 0/18 • 6 Years	3.1% 1/32 • Number of events 1 • 6 Years
Skin and subcutaneous tissue disorders Acute Graft Versus Host Disease	5.6% 1/18 • Number of events 1 • 6 Years	0.00% 0/32 • 6 Years
Skin and subcutaneous tissue disorders Chronic Graft Versus Host Disease	5.6% 1/18 • Number of events 1 • 6 Years	0.00% 0/32 • 6 Years
Blood and lymphatic system disorders Neutropenia	0.00% 0/18 • 6 Years	3.1% 1/32 • Number of events 1 • 6 Years
Blood and lymphatic system disorders Anemia	5.6% 1/18 • Number of events 1 • 6 Years	6.2% 2/32 • Number of events 2 • 6 Years
Renal and urinary disorders Elevated creatinine	0.00% 0/18 • 6 Years	3.1% 1/32 • Number of events 1 • 6 Years
Blood and lymphatic system disorders Hyperglycemia	0.00% 0/18 • 6 Years	3.1% 1/32 • Number of events 1 • 6 Years
Hepatobiliary disorders Elevated Transaminase Level	5.6% 1/18 • Number of events 1 • 6 Years	0.00% 0/32 • 6 Years
Hepatobiliary disorders Elevated Bilirubin level	5.6% 1/18 • Number of events 1 • 6 Years	0.00% 0/32 • 6 Years

Other adverse events

Adverse event data not reported

Additional Information

Roy F Chemaly, MD/MPH, MBA /Associate Professor

UT MD Anderson Cancer Center

Phone: 713-745-1116

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place