Status:
COMPLETED
Artesunate in Preemptive Treatment of Human Cytomegalovirus (CMV) in Stem Cell Transplant Recipients
Lead Sponsor:
Hadassah Medical Organization
Collaborating Sponsors:
Institut für Klinische und Molekulare Virologie
University of Erlangen-Nürnberg Medical School
Conditions:
Cytomegalovirus Infections
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Human cytomegalovirus (HCMV) has remained a major cause of morbidity and mortality following allogeneic bone marrow or peripheral blood stem cell transplantation (SCT). The most reliable virological p...
Eligibility Criteria
Inclusion
- Patients aged \> 18 years.
- Patients undergoing matched hematopoietic stem cell transplantation (HSCT), with antigenemia ≥ 1 positive cells/200,000 WBC, and/or CMV DNA load between 2000-10,000 copies/ml.
- Had a tri-lineage hematopoietic engraftment.
- Can take oral medications.
Exclusion
- Not fulfilling the inclusion criteria.
- History of, or active HCMV disease\*.
- Anti-CMV therapy within the past 15 days.
- Haploidentical HSCT.
- Uncontrolled graft-versus-host disease (GVHD).
- Uncontrolled or untreated bacterial, fungal, or viral (non-CMV) infection.
- Patients receiving \> 2mg/kg/day prednisone treatment.
- Severe, uncontrolled diarrhea.
- Evidence of malabsorption.
- Inability to comply with study requirements.
- Known hypersensitivity to artesunate.
- Patients with relative contraindications to artesunate: preexisting cardiac or central nervous system disease
- Pregnant or lactating patients.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00284687
Start Date
July 1 2006
End Date
March 1 2010
Last Update
June 10 2010
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel, 91120