Clinical trial NCT00016081: Ribavirin Compared With Standard Care in Treating Patients With Respiratory Syncytial Virus Following Stem Cell Transplantation
Official title: A Randomized Phase III Study To Evaluate The Safety And Efficacy Or Ribavirin Inhaled Solution In Preventing Progression Of Upper Respiratory Tract Respiratory Syncytial Virus (RSV) Infection To RSV Pneumonia In Blood And Bone Marrow Transplant (BMT) Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infection
Keywords: infection
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: OBJECTIVES:

* Compare the efficacy of aerosolized ribavirin vs standard supportive therapy, in terms of preventing progression of upper respiratory tract respiratory syncytial virus (RSV) infection to pneumonia, in patients with RSV following stem cell transplantation.
* Determine the safety of aerosolized ribavirin in this patient population.

OUTLINE: This is a randomized, investigator-blind, controlled, multicenter study. Patients are stratified according to engraftment status (pre vs post) and transplant type (HLA matched-related allogeneic, syngeneic, or autologous vs HLA mismatched-related or unrelated allogeneic). Patients are randomized to one of two treatment arms.

* Arm I: Patients receive standard supportive care for immunocompromised patients with upper respiratory tract infections. Patient also receive aerosolized ribavirin by face mask, mist, or oxygen tent over 2 hours 3 times daily on days 1-10.
* Arm II: Patients receive standard supportive care as in arm I. Treatment continues in the absence of progression to pneumonia or unacceptable toxicity.

Patients are followed at days 14 and 28.

PROJECTED ACCRUAL: A total of 90 patients (45 per arm) will be accrued for this study.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Comprehensive Cancer Center
state: Alabama
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Saint Louis
country: United States
facility: Siteman Cancer Center
state: Missouri
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Michael Boeckh, MD
role: STUDY_CHAIR
References: