Status:
COMPLETED
COMBISTRAT: AmBisome® in Combination With Caspofungin for the Treatment of Invasive Aspergillosis
Lead Sponsor:
Gilead Sciences
Conditions:
Invasive Aspergillosis
Eligibility:
All Genders
10+ years
Phase:
PHASE4
Brief Summary
Combination therapy of caspofungin and amphotericin B could be a useful treatment option in invasive fungal disease, but before it can be routinely recommended; carefully controlled and well-designed ...
Detailed Description
Efficacy and toxicity of caspofungin in combination with AmBisome® as primary or salvage treatment of invasive aspergillosis has already been assessed in patients with hematologic malignancies. Forty-...
Eligibility Criteria
Inclusion
- Adults and children \> 10 years old.
- The patient is able to understand and has signed a written informed consent OR the parent or legal guardian is able to understand and has signed a written informed consent, which must be obtain prior to the initiation of any study procedures.
- Immunocompromised due to hematologic malignancies, chemotherapy-induced neutropenia, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy (≥ 20 mg Prednisone or equivalent for ≥ 3 weeks) or treatment with other immunosuppressant medications.
- Evidence of Proven or Probable Invasive Aspergillosis, by modified EORTC criteria (Appendix 2), as modified below: • Proven Invasive Aspergillosis • Histopathologic or cytopathologic examination showing hyphae consistent with the presence of aspergillus from needle aspiration or biopsy specimen with evidence of associated tissue damage (either microscopically or unequivocally by imaging); or • Positive culture result for aspergillosis from a sample obtained by sterile procedure from normally sterile and clinically or radiologically abnormal site consistent with infection, excluding urine and mucous membranes • Probable Invasive Aspergillosis • At least 1 host factor criterion; and • 1 microbiological criterion; and
- 1 major (or 2 minor) clinical criteria from abnormal site consistent with infection; and • No other pathogens detected to account for the clinical or radiographic signs of infection
- Or (Modification of EORTC Criteria): • Patients with recent Neutropenia (absolute neutrophil count \< 500 cells/mm3 within 14 days of study enrollment); and • Chest CT scan positive for "Halo" or "Air Crescent" Sign (see Section 4.2.1, Diagnostic Considerations, below) and • No other pathogens detected to account for the clinical or radiographic signs of infection
- Females of childbearing potential must be surgically incapable of pregnancy, or practicing an acceptable method of birth control with a negative pregnancy test (blood or urine) at baseline.
Exclusion
- Life expectancy \< 30 days
- Allogenic stem cell transplant in the 6 previous months
- Chronic invasive fungal infection, defined as signs/symptoms of invasive fungal infection present for \> 4 weeks preceding entry into study
- Prior anti-fungal systemic therapy of ≥ 96 hours for the current, documented IA. (On the other hand, is permissible prior systemic anti-fungal therapy for prophylaxis or as empiric therapy for febrile neutropenia).
- Use of another investigational, unlicensed drug within 30 days of screening or concurrent participation in another clinical trial using an investigational, unlicensed drug • Serum creatinine \> 2x upper limit of normal (ULN)
- Serum ALT or AST \> 5 x ULN
- Pregnant or lactating women
- History of allergy or serious adverse reaction to any polyene anti-fungal agent or echinochandin derivatives
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00334412
Start Date
March 1 2004
End Date
May 1 2006
Last Update
July 9 2015
Active Locations (1)
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1
Gilead Sciences
Paris, France, 75015