MDACC Study Summary 2005-0622

Study Summary
No. 2005-0622:.......Infection......Issam Raad......Infectious Disease

Study Summary Title



Study Summary Number:	2005-0622

Study Title:	Phase II, Open-Label Study to Evaluate the Safety and Efficacy of Daptomycin in the Treatment of Catheter-Related Staphylococcus aureus Bloodstream Infections

Physician

New Patient Referral



Name:	Issam Raad	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Infectious Disease	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-7943 Contact us about clinical trials

General Information



Disease Group:	Infection	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	End of Treatment ( EOT) will be performed within 7-14 days after the last dose of study is administered. A Last Follow-UP (LFU) evaluation will be performed within 32 (+/-7) days after the last dose of study drug is administered.

Treatment Agents:	Daptomycin	Home Care:	Home infusion of study drug is allowed, if possible

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	The duration of study drug therapy will be at least 10 days. The study drug can be administered in both Inpatient and Outpatient Basis and/or home administration if possible


Description/ Intervention:	The goal of this clinical research study is to learn if Daptomycin can help to control catheter-related bloodstream infections (CBRSI) with or without exchange of the central venous catheter (CVC) over guide wire . The safety of this treatment will also be studied.

Study Objectives / Outcomes

Evaluate the efficacy and safety of daptomycin given for treatment of catheter-related bloodstream infections due to S. aureus bacteria with or without exchange of the CVC over guide wire in comparison with a historical control group of catheter-related S. aureus bacteremia treated with standard therapy (Vancomycin) or other active agents against staph aureus (such as beta-lactam antibiotics).

Study Status Information



Study Activation / Registration Date:	05/30/2006

IRB Review and Approval Date:	12/07/2005

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Male or non-pregnant, non-lactating females with an age of greater than or equal to 18 years.

2) The suspected culprit on exchangeable CVC is tunnel ( including implanted ports) or non-tunneled catheter, antibiotic or non-antibiotic coated catheter inserted in the subclavian, jugular or femoral vein.

3) Patients must have at least two signs of sepsis from the list below, in any combination, within 48 hours prior to Daptomycin therapy and no other source for the bacteremia other than CVC: (a) Core temperature =/>38.0 degrees C or =/<36.0 degrees C, measured orally, rectally, tympanically or via a central catheter. If axcillary add 0.5 degrees C to the measured temperature; (b) Pulse rate =/> 100 beats/min.; (c) Respiratory rate =/> 20/min; (d) WBC count =/>12,000/mm^3 or =/<4,000/mm^3 differential count showing >10% band forms; (e) Systolic blood pressure=/ <90 mm Hg

4) Patients with suspected or definite diagnosis of uncomplicated CVC-related gram-positive bacteremia that includes at least one positive blood culture for S aureus. (If the positive blood culture is drawn through the CVC, then at least >15 colonies/ml will be required or the differential time of positive ( DTP) of CVC at least 2 hours earlier than the peripheral culture)

5) Signed informed consent

6) No apparent source for the clinical manifestation of bacteremia other than the catheter

Exclusion Criteria:

1) Creatinine clearance <30 mL/min at the time gram positive bacteremia was diagnosed unless the patient is on dialysis

2) Bilirubin >4x the upper limit of normal at the time gram positive bacteremia was diagnosed

3) Treatment with an antibiotic effective against Gram-positive bacterial infections for more than 48 hours within 72 hours of study medication initiation, unless treatment failed.

4) Documented S. aureus bacteremia within last 3 months due to source other than CVC.

5) Patients who have participated in another investigational anti-infective study within 30 days

6) History of hypersensitivity to lipopeptides

7) Presence of additional source of infection with same organism cultured from blood, eg. endocarditis (as evidenced by vegetations on an echocardiogram), septic thrombosis

8) Conditions with markedly decreased albumin in plasma (<1.5 g/dl), e.g., cirrhosis, nephritic syndrome, end-stage renal disease

9) Anticipated prolonged therapy >4 weeks

10) Prosthetic endovascular material

11) Oliguria defined as urine output of <20 cc/hour averaged over 24 hours.

12) Possible complicated CRBSI with persistent bacteremia for more than 48 hours on active antimicrobial therapy (such as osteomyelitis, endocarditits, and septic thrombosis.)

13) Evidence of catheter site purulence as evidenced by purulent discharge.

14) Patients with diagnosis of pneumonia that is related to S. aureus organism

15) Patients taking concomitant "statins" (HMG-CoA reductase inhibitors)

16) CPK >10X max-normal in asymptomatic patients and CPK >5 max-normal in symptomatic patients.

Links

Registration Number: NCT00507247
Study Information on Clinical Trials Registry (clinicaltrials.gov)