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An Open Label Randomized Controlled Trial To Prevent the Progression of Respiratory Syncytial Virus Upper Respiratory Tract Infection to Lower Respiratory Tract Infection in Patients After Hematopoietic Stem Cell Transplant


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Bone Marrow Transplant Infection, Infection in Marrow Transplant Recipients, Respiratory Syncytial Virus Infections, Respiratory Syncytial Virus Pneumonia, Cancer, Acute Leukemia

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Trial Information

An Open Label Randomized Controlled Trial To Prevent the Progression of Respiratory Syncytial Virus Upper Respiratory Tract Infection to Lower Respiratory Tract Infection in Patients After Hematopoietic Stem Cell Transplant


Study Groups:

If you are found to be eligible to take part in this study and the study doctor thinks that
the disease requires treatment at this time, you will be randomly assigned (as in the flip
of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to
either group:

- If you are in Group 1, you will receive the inhaled form of ribavirin. You will inhale
ribavirin 3 times a day for 3 hours each time in a tent in a hospital room. You will
receive the drug for up to 10 days.

- If you are in Group 2, you will take capsules of ribavirin 3 times a day for up to 10
days.

If the study doctor does not think that the disease requires treatment at this time, you
will be assigned to Group 3. If you are in Group 3, you will not receive treatment with
ribavirin, but you will have the same tests and procedures at the study visits described
below.

Study Visits:

At all study visits, you will be asked about how you are feeling, about any side effects or
symptoms you may be having, and about any other drugs you may be taking.

On Day 3 (+/- 1 day):

- You will have a physical exam, including measurement of your vital signs

- Your nasal passages will be checked for RSV.

On Days 7 and 14 (+/- 1 day):

- Blood (about 2 teaspoons) will be drawn for routine tests.

- You will have a physical exam, including measurement of your vital signs

- Your nasal passages will be checked for RSV.

Length of Study:

If you are in Groups 1 or 2, you will receive the study drug for up to 10 days. You will no
longer be able to take the study drug if the disease gets worse, if intolerable side effects
occur, or if you are unable to follow study directions. If your doctor thinks you need
treatment longer than 10 days, you will receive that as part of your routine care. This may
mean changing to receiving the drug in inhaled form if you began the study receiving it by
mouth.

All participants will have end-of-study and follow-up visits, as described below.

End-of-Study Visit:

If you are in Groups 1 or 2, the end-of-study visit will be about 14 days after your last
dose of the study drug. If you are in Group 3, the end-of-study visit will take place at
about Day 21. The following tests and procedures will be performed:

- You will have a physical exam, including measurement of your vital signs.

- Blood (about 4 teaspoons) will be drawn for routine tests and to check for RSV
antibodies.

- Your nasal passages will be checked for RSV.

- You will be asked about how you are feeling, about any side effects or symptoms you may
be having, and about any drugs you may be taking.

Follow-Up Visit:

About 60 days after your last dose of study drug, you will have a pulmonary function test to
check your lung function.

This is an investigational study. Ribavirin is FDA approved and commercially available for
the treatment of hepatitis C when given by mouth, and for severe RSV in children when
inhaled. Giving the drug to adults with weak immune systems after a stem cell transplant is
investigational.

Up to 96 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. HSCT patients with either moderate or risks or high risks immunodeficiency based on
immunodeficiency scoring system would be eligible for entry on study if a
nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing
and/or on culture within 72 hours (therapeutic arms). (Please see Appendix E for
definitions and Immunodeficiency Scoring).

2. HSCT patients with low risk immunodeficiency based on immunodeficiency scoring system
would be eligible for entry on study if a nasopharyngeal wash or throat swab specimen
is positive by rapid RSV antigen testing and/or on culture within 72 hours but will
not be randomized to therapeutic arms and will be followed as per standard of care
(control arm).

3. Patients must be at least 18 years of age and able to swallow pills.

4. Patients with RSV infection limited to the URT as documented by negative Chest
radiographic findings within the last 48 hours of enrollment and pulse oxygenation of
more than 90 mm of Hg on room air.

5. Women of child bearing potential with a negative urine or blood pregnancy test within
a month of enrollment (only for patients who are going to be randomised to either
therapeutic arms).

6. Patients with Hemoglobin levels more than or equal to 8 g/dl would be eligible for
the study even if they are currently receiving blood products.

7. Patients may receive up to 2 doses of aerosolized ribavirin (modified regimen) before
enrollment into the study.

8. Patients who will be enrolled on the observational arm should meet inclusion criteria
# 2, 3, and 4 only.

Exclusion Criteria:

1. Patients with previous history of hypersensitivity to ribavirin or its components

2. Women who are pregnant or plan a pregnancy within 8 weeks after completion of
treatment (only for patients who are going to be randomised to either therapeutic
arms).

3. Patients with evidence of RSV LRI as documented by a positive rapid RSV antigen
testing and/or culture on nasal washes AND new or progressive infiltrates on chest
radiographic studies suggestive of viral etiology and/or pulse oxygen less than 90 mm
of Hg on room air.

4. Patients with positive RSV by rapid antigen testing and/or culture in bronchoalveolar
lavage regardless of the chest radiographic findings.

5. Patients who are considered to be moderately or severely anemic as per the NCI
classification will not be included in the study, i.e patients with hemoglobin level
less than 8 g/dl

6. Patient with Total Bilirubin and Aspartate Aminotransferase (AST) or Alanine
Aminotransferase (ALT) three times the upper limit of normal.

7. Male partners of women who are pregnant (only for patients who are going to be
randomised to either therapeutic arms).

8. Patients with known history of autoimmune hepatitis, Hepatitic C or those with
hemoglobinopathies (eg, thalassemia major, sickle cell anemia).

9. Patients with creatinine clearance of less than or equal to 50 ml/Min

10. Patients taking didanosine, azathioprine, or nucleoside reverse transcriptase
inhibitors

11. Patients who will be enrolled on the observational arm should not meet exclusion
criteria #3 and 4 only.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Progression to Lower Respiratory Tract Infection (LRI)

Outcome Description:

Progression to LRI (i.e., pneumonia) by day 14 after the completion of therapy evaluated by nasal washes repeated on day 3 ±1 day, day 7 (± 2 days), day 14 (+ 2 days), and by day 14 + 2 days after end of therapy; Blood specimens drawn by 14 + 2 days after end of therapy.

Outcome Time Frame:

14 days

Safety Issue:

No

Principal Investigator

Roy F. Chemaly, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2011-0813

NCT ID:

NCT01502072

Start Date:

December 2011

Completion Date:

Related Keywords:

  • Bone Marrow Transplant Infection
  • Infection in Marrow Transplant Recipients
  • Respiratory Syncytial Virus Infections
  • Respiratory Syncytial Virus Pneumonia
  • Cancer
  • Acute Leukemia
  • Ribavirin
  • Ribavirin Aerosol
  • Respiratory Syncytial Virus
  • RSV
  • upper respiratory tract infection
  • URI
  • Lower respiratory tract Infection
  • LRI
  • pneumonia
  • aerosolized ribavirin
  • HSCT
  • Hematopoietic stem cell transplantation
  • oral ribavirin therapy
  • Leukemia
  • Pneumonia
  • Respiratory Syncytial Virus Infections
  • Respiratory Tract Infections
  • Virus Diseases

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030