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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00771719
Other study ID # CR015304
Secondary ID NOS-1002
Status Terminated
Phase Phase 1
First received October 9, 2008
Last updated July 27, 2012
Start date October 2008
Est. completion date November 2009

Study information

Verified date July 2012
Source Basilea Pharmaceutica
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to measure the levels of ceftobiprole in the blood, urine and tissues of the lungs during and after administration of four doses of ceftobiprole. Safety of the drug will also be evaluated.


Description:

Patients will receive a intravenous dose of ceftobiprole infused over 4 hours. Multiple blood samples will be obtained to determine the concentration of Ceftobiprole in the blood. Bronchoalveolar lavage (BAL) samples will be collected to determine the concentration of ceftobiprole in the BAL fluid. The penetration of the drug into the lung will be calculated. Four 1000mg administered every 8 hours


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date November 2009
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Informed Consent

- Between 18 and 75 years of age inclusive

- VAP - 48 hours after onset of mechanical ventilation

- BMI 18 - 35 inclusive

- Albumin < 3.3 g/dL or clinical evidence of edema

- Negative Pregnancy test

- Expected survival of at least 7 days

Exclusion Criteria:

- Renal impairment (CrCl < 80 mL/min)

- Known drug allergy (including penicillin, cephalosporin, carbapenems, or other beta-lactams)

- History of seizures

- Sustained shock, unresponsive to sympathomimetics

- Conditions that may have jeopardized adherence to the protocol (NYHA Class 4 cardiac disease, >15% total body burn or significant third degree burn)

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Ceftobiprole
Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Basilea Pharmaceutica

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine and tissues of the lungs) during dosing and 24 hours after last dose infused 2 days No
Secondary Safety will be evaluated throughout the study. Study Duration Yes
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