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Sponsored by: |
Cubist Pharmaceuticals |
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Information provided by: | Cubist Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00055198 |
The purpose of this study is to provide daptomycin, an antibiotic, to patients who are failing conventional therapy, or who cannot take approved antibiotics for one reason or another.
Condition | Intervention | Phase |
---|---|---|
Gram-Positive Bacterial Infections |
Drug: daptomycin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study |
Official Title: | A Compassionate Use Protocol for Intravenous Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria That Cannot be Adequately Treated With Currently Available Therapy |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
(**) An exemption may be granted for patients not satisfying these criteria following a conversation with the Medical Monitor.
Study ID Numbers: | DAP-EAP-02-01 |
Study First Received: | February 20, 2003 |
Last Updated: | January 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00055198 |
Health Authority: | United States: Food and Drug Administration |
Gram positive bacterial infections expanded access program resistant infections |
bacteremia Bacterial and fungal infections bacterial infections |
Daptomycin Bacterial Infections Mycoses Gram-Positive Bacterial Infections Bacteremia |
Anti-Infective Agents Anti-Bacterial Agents Communicable Diseases |
Therapeutic Uses Infection Pharmacologic Actions |