COMBISTRAT: AmBisome® in Combination With Caspofungin for the Treatment of Invasive Aspergillosis

NCT00334412 | Completed Phase 4

• 1 other identifier: GS-FR-131-0106
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 randomized clinical trials are needed.

Conditions

Invasive Aspergillosis

Outcome Measures

Primary Outcomes (1)

• To assess efficacy of AmBisome® in combination with caspofungin (Cancidas®) versus AmBisome® high dose regimen in the treatment of Invasive Aspergillosis diagnosed by modified EORTC criteria in immunocompromised patients as probable or proven and deter

Secondary Outcomes (5)

• To evaluate and compare the safety and tolerability of the two arms.

• To determine the survival rates and rates of infection relapse at 4 weeks post-treatment for patients treated with each of the two treatment regimens.

• To determine the survival rate at 12 weeks after study entry for patients treated with each of the two treatment regimens.

• To determine and compare the time to favorable response and time to maximal overall response for each of the two treatment regimens.

• To compare the efficacy of each arm versus historical data on conventional amphotericin B and voriconazole for the treatment of Invasive Aspergillosis.

Interventions

Ambisome DRUG

caspofungin DRUG

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Gilead Sciences

Paris, 75015, France

Location

MeSH Terms

Interventions

liposomal amphotericin B; Caspofungin

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Lamine Mahi, MD

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 5, 2006
• First Posted: June 7, 2006
• Study Start: March 1, 2004
• Study Completion: May 1, 2006
• Last Updated: July 9, 2015

Record last verified: 2015-07

Locations

FR (1)