NCT00500578

Brief Summary

Primary Objectives:

  1. 1.To determine whether aerosolized ribavirin is effective when given at an intermittent dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection (URI) and whether it can prevent progression to pneumonia.
  2. 2.To determine the effect of this regimen on persistence of viral shedding.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

September 16, 2010

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

5.9 years

First QC Date

July 10, 2007

Results QC Date

June 1, 2010

Last Update Submit

July 27, 2012

Conditions

Hematological Malignancies

Keywords

Hematological MalignanciesRespiratory InfectionRespiratory Syncytial VirusRSVRibavirinVirazole

Outcome Measures

Primary Outcomes (1)

  • Occurrences of Pneumonia

    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.

    6 Years

Study Arms (2)

1: Standard Schedule - Ribavirin

EXPERIMENTAL

Aerosolized Ribavirin 6 grams over 18 hours every 24 hours

Drug: Ribavirin

2: Modified Schedule - Ribavirin

EXPERIMENTAL

Aerosolized Ribavirin 2 grams over 3 hours every 8 hours

Drug: Ribavirin

Interventions

RibavirinDRUG

Arm 1 = 6 Grams Over 18 hours Every 24 Hours

Also known as: Virazole
1: Standard Schedule - Ribavirin

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with these underlying malignancies will be eligible for this study: Autologous BMT patients, Allogeneic BMT patients, and patients with hematological malignancy.
  • Patients must be at least 5 years of age.
  • Only patients with infection limited to the URT will be eligible for entry on study
  • Patients will be eligible for entry on study if a nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing or by a positive culture for RSV.

You may not qualify if:

  • Patients with evidence of RSV LRTI as documented by a positive rapid RSV antigen testing or by a positive culture for RSV from a nasopharyngeal wash or throat swab AND new infiltrates on chest radiograph and/or abnormal blood gas determination
  • Patients with hypersensitivity to ribavirin or its components
  • Pregnant women. Participants must practice birth control during the study if they are sexually active. If the participant is pregnant, she may not be enrolled on this study. Mothers should refrain from breast-feeding during the study to avoid injury to their children.
  • Patients with positive RSV by rapid testing or culture in bronchoalveolar lavage regardless of the chest radiographic results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Chemaly RF, Torres HA, Munsell MF, Shah DP, Rathod DB, Bodey GP, Hosing C, Saifan C, Raad II, Champlin RE. An adaptive randomized trial of an intermittent dosing schedule of aerosolized ribavirin in patients with cancer and respiratory syncytial virus infection. J Infect Dis. 2012 Nov;206(9):1367-71. doi: 10.1093/infdis/jis516. Epub 2012 Aug 22.

    PMID: 22927454DERIVED

Related Links

MeSH Terms

Conditions

Hematologic NeoplasmsRespiratory Tract Infections

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesInfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

The interpretation of our data is limited by our study's open-label design, which may bias assessments of tolerability or toxicity but would be less likely to bias assessments of therapeutic endpoints.

Results Point of Contact

Title
Roy F Chemaly, MD/MPH, MBA /Associate Professor
Organization
UT MD Anderson Cancer Center
rfchemaly@mdanderson.org
713-745-1116

Study Officials

  • Roy F. Chemaly, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 12, 2007

Study Start

February 1, 2003

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

August 1, 2012

Results First Posted

September 16, 2010

Record last verified: 2012-07

Locations

US(1)