Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00055198
  4. Details
NCT00055198 Clinical Trial

Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria

Gram-Positive Bacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00055198
Other study ID # 3009-012
Secondary ID DAP-EAP-02-01
Status Terminated
Phase Phase 3
First received February 20, 2003
Last updated June 12, 2017
Start date December 19, 2002
Est. completion date January 26, 2004

Study information
Verified date June 2017
Source Cubist Pharmaceuticals LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 75
Est. completion date January 26, 2004
Est. primary completion date January 26, 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• daptomycin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cubist Pharmaceuticals LLC
See also
  Status Clinical Trial Phase
Completed NCT01412801 - Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings Phase 2
Completed NCT00501150 - Oral Antibiotic Treatment at Home Instead of Intravenous Treatment in Hospital for Resistant Gram Positive Infections N/A
Terminated NCT00108433 - Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections Phase 3
Not yet recruiting NCT06444802 - Model-informed Precision Dosing for Linezolid Phase 3
Terminated NCT00529282 - A Study of Ceftobiprole in Patients With Fever and Neutropenia. Phase 3
Completed NCT00079976 - Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA) Phase 3
Terminated NCT00835783 - Validation Study of Combined Positron Emission Tomography/Computer Tomography to Diagnose Infection and Inflammation N/A
Completed NCT00081744 - Study Comparing Tigecycline to Imipenem/Cilastatin in Complicated Intra-Abdominal Infections in Hospitalized Subjects Phase 3
Completed NCT03747497 - Contezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection Phase 2
Active, not recruiting NCT04911270 - Clinical Decision Support Tool for Vancomycin Dosing in Children N/A
Completed NCT02750761 - A Study of Oral and Intravenous (IV) Tedizolid Phosphate in Hospitalized Participants, Ages 2 to <12 Years, With Confirmed or Suspected Bacterial Infection (MK-1986-013) Phase 1
Completed NCT00406198 - Impact of Continuous Venovenous Haemofiltration on Organ Failure During the Early Phase of Severe Sepsis Phase 4
Completed NCT03560440 - Evaluation of the Dosing Regimen of Vancomycin in Pediatric Patients
Completed NCT00147511 - Time To Efficacy and Onset Of Action Of Linezolid Phase 4
Terminated NCT00240747 - Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients Phase 3
Not yet recruiting NCT04917380 - The Clinical Character，Risk and Prognosis of Post-neurosurgical Intracranial Infection With Different Pathogens.
Completed NCT00736554 - What is the Prevalence of Methicillin-Resistant Staphylococcus Aureus in Skin and Soft Tissue Infections Presenting to the Emergency Departments of a Canadian Academic Health Care Center? N/A
Completed NCT03361163 - Controlled Human Infection for Vaccination Against Streptococcus Pyogenes Phase 1
Completed NCT00167960 - Study Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit Phase 4
Completed NCT00874367 - Early-Onset Sepsis Surveillance Study N/A