NCT00016081

Brief Summary

RATIONALE: Antivirals such as ribavirin are used to treat infections caused by viruses. It is not yet known if ribavirin is more effective than standard therapy in preventing pneumonia in patients who have respiratory syncytial virus (RSV) infection following stem cell transplantation. PURPOSE: Randomized phase III trial to compare the effectiveness of ribavirin with that of standard therapy in preventing pneumonia in patients who have RSV infection following stem cell transplantation.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Mar 1998

Longer than P75 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1998

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2001

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

March 30, 2010

Status Verified

March 1, 2010

Enrollment Period

5 years

First QC Date

May 6, 2001

Last Update Submit

March 26, 2010

Conditions

Infection

Keywords

infection

Interventions

ribavirinDRUG

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Confirmed upper respiratory tract respiratory syncytial virus (RSV) infection documented in nasopharyngeal-throat specimen by rapid antigen test (ELISA), IFA, or shell vial) * Signs or symptoms of upper respiratory tract infection (e.g., rhinorrhea and/or low-grade fever (under 101 degrees F with or without evidence of a sore throat) * Received prior stem cell transplantation (SCT) and meet one of the following criteria: * Between start of conditioning (preparative) regimen and day 90 after allogeneic, autologous, or syngeneic SCT * Between days 91 and 180 after unrelated or HLA mismatch-related allogeneic SCT * Between days 91 and 180 after SCT with graft-versus-host disease requiring systemic steroids expected to continue throughout study * No radiographic evidence of pneumonia PATIENT CHARACTERISTICS: Age: * 2 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Pulmonary: * Oxygen saturation 92-100% by pulse oximeter * Normal respiratory rate for age Other: * No prior adverse reactions to ribavirin * No clinical status that would preclude study * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior immunotherapy for RSV * No prior or concurrent RSV hyperimmune globulin or monoclonal antibodies Chemotherapy: * Not specified Endocrine therapy: * See Disease Characteristics Radiotherapy: * Not specified Surgery: * Not specified Other: * No prior antiviral drugs with anti-RSV activity * Bronchodilator treatment allowed for patients with asthma or a history of reactive airway disease and/or who develop bronchospasm * Concurrent ganciclovir, foscarnet, or IV immunoglobulin allowed * No mechanical ventilation * No other concurrent anti-viral drugs with anti-RSV activity

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35233, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Ribavirin

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Michael Boeckh, MD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2001

First Posted

January 27, 2003

Study Start

March 1, 1998

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

March 30, 2010

Record last verified: 2010-03

Locations

US(4)