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Respiratory Syncytial Virus - RSV Protocol

NCT01502072 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-02-15

Study results available
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Summary

The goal of this clinical research study is to learn if ribavirin can help to control RSV in patients with immune systems that have been weakened by a stem cell transplant. Researchers also want to compare the effectiveness of the drug when it is given by mouth to when it is inhaled. The safety of the drug in both methods of delivery will be studied.

Ribavirin is designed to prevent the RSV virus from making more copies of itself in the body.

Conditions

  • Bone Marrow Transplant Infection
  • Infection in Marrow Transplant Recipients
  • Respiratory Syncytial Virus Infections
  • Respiratory Syncytial Virus Pneumonia
  • Cancer
  • Acute Leukemia

Interventions

DRUG

Ribavirin

Modified schedule of 60 milligrams/milliliter for 3-hour period 3 times/day for at least 5 days by aerosolization via a SPAG-2 generator via a face mask.

DRUG

Ribavirin

One time loading dose of 10 mg/kg oral dose then 20 mg/kg orally (rounded to the nearest 200 mg dose) divided into three doses per day (max 1800 mg/day).

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Roy F. Chemaly, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-28
Primary Completion
2020-02-01
Completion
2020-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01502072 on ClinicalTrials.gov