Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria
This study has been completed.
Sponsor:
Cubist Pharmaceuticals
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00055198
First received: February 20, 2003
Last updated: January 30, 2007
Last verified: December 2006
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Bacterial Infections
Drug Information available for:
Daptomycin
U.S. FDA Resources
Further study details as provided by Cubist Pharmaceuticals:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Main Inclusion Criteria:
- Infection caused by Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis, or Enterococcus faecium that requires inpatient hospitalization and treatment with injectable antibiotics**
- Site of infection: complicated skin and skin structure infection; urinary tract infection; intra-abdominal infection; infective endocarditis; or bloodstream infection (including catheter–related).
- Pathogen resistant to, or patient intolerant of: beta-lactams, vancomycin, quinupristin/dalfopristin, or linezolid.
- Unable to receive any other standard commercially available antibacterial therapy for the infection.
Main Exclusion Criteria:
- Creatinine clearance less than 40 mL/min**
- Hemodialysis or peritoneal dialysis
- Admitted to the hospital for drug overdose or other conditions associated with rhabdomyolysis, or is expected to require repeated intramuscular injections
- Creatine phosphokinase (CPK) level greater than 2.5 times above the upper limit of normal (ULN) at screening; if the elevation in CPK can be attributed to an obvious cause (eg, surgery)**
- Central nervous system infection
- Pulmonary infection.
(**) An exemption may be granted for patients not satisfying these criteria following a conversation with the Medical Monitor.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00055198 History of Changes |
| Other Study ID Numbers: | DAP-EAP-02-01 |
| Study First Received: | February 20, 2003 |
| Last Updated: | January 30, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cubist Pharmaceuticals:
|
Gram positive bacterial infections expanded access program resistant infections |
bacteremia Bacterial and fungal infections bacterial infections |
Additional relevant MeSH terms:
|
Bacterial Infections Gram-Positive Bacterial Infections Daptomycin Anti-Bacterial Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013