Staphylococcus AureusPhase 2NCT00507247
Daptomycin in the Treatment of Catheter-Related Staphylococcus Aureus
A Phase 2 study testing Daptomycin in people with Staphylococcus Aureus, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: 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 central venous catheter (CVC) over guide wire in comparison with a historical control group of catheter-related S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus
- What is being tested?
- Daptomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Sep 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-lactating females with an age of greater than or equal to 18 years.
- The suspected culprit on exchangeable central venous catheter (CVC) is tunnel ( including implanted ports) or non-tunneled catheter, antibiotic or non-antibiotic coated catheter inserted in the subclavian, jugular or femoral vein.
- 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 axillary add 0.5 degrees C to the measured temperature; (b) Pulse rate =/> 100 beats/min.; (c) Respiratory rate =/> 20/min; (d) white blood count (WBC) count =/>12,000/mm^3 or =/<4,000/mm^3 differential count showing >10% band forms; (e) Systolic blood pressure=/ <90 mm Hg
- 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)
- Signed informed consent
- No apparent source for the clinical manifestation of bacteremia other than the catheter
Who cannot join
- Creatinine clearance <30 mL/min at the time gram positive bacteremia was diagnosed unless the patient is on dialysis
- Bilirubin >4 times the upper limit of normal at the time gram positive bacteremia was diagnosed
- 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.
- Documented S. aureus bacteremia within last 3 months due to source other than CVC.
- Patients who have participated in another investigational anti-infective study within 30 days
- History of hypersensitivity to lipopeptides
Show all 16Show fewer
- Presence of additional source of infection with same organism cultured from blood, eg. endocarditis (as evidenced by vegetations on an echocardiogram), septic thrombosis
- Conditions with markedly decreased albumin in plasma (<1.5 g/dl), e.g., cirrhosis, nephritic syndrome, end-stage renal disease
- Anticipated prolonged therapy >4 weeks
- Prosthetic endovascular material
- Oliguria defined as urine output of <20 cc/hour averaged over 24 hours.
- Possible complicated CRBSI with persistent bacteremia for more than 48 hours on active antimicrobial therapy (such as osteomyelitis, endocarditis, and septic thrombosis.)
- Evidence of catheter site purulence as evidenced by purulent discharge.
- Patients with diagnosis of pneumonia that is related to S. aureus organism
- Patients taking concomitant "statins" (HMG-CoA reductase inhibitors)
- creatine phosphokinase (CPK) >10 times max-normal in asymptomatic patients and CPK >5 max-normal in symptomatic patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase II, Open-Label Study to Evaluate the Safety and Efficacy of Daptomycin in the Treatment of Catheter-Related Staphylococcus Aureus Bloodstream Infections
Primary Objective:
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 central venous catheter (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).
Read the detailed description
Daptomycin is a new antibiotic. It may be effective against a variety of bacterial infections that are difficult to treat.
Aztreonam, Cefepime, Carbapenems and Augmentin are antibiotics that are used to treat certain types of bacteria.
If you are found to be eligible to take part in this study, you will be given daptomycin by vein for at least 10 days, depending on your certain type of bacteria. You will receive Daptomycin by vein for 30 minutes every 24 hours.
The CVC associated with CRBSI (catheter-related bloodstream infection = CR-BSI) from all enrolled patients will either be removed or be exchanged over guide wire for a new CVC within 96 hours of onset of the first blood culture. Your primary doctor will decide whether to remove or exchange the CVC with the willingness of you.
If the study doctor and/or your primary physician knows or thinks that you have a mixed infection (both "gram positive" and "gram negative") or may have infection in lungs (pneumonia), you may also be treated with the antibiotic drugs Aztreonam, Cefepime, Carbapenems, or Augmentin by vein or by mouth in combination with the study drug Daptomycin.
During each week of treatment, blood (about 1 tablespoon) will be drawn for routine lab tests. The blood sample may be drawn from the CVC, if the CVC is still in place. In addition, blood (about 1 tablespoon) will be drawn every other day until it no longer shows signs of infection. The catheter exit site may be examined at each visit until you have no more signs or symptoms of infection. If you are discharged from the hospital before completing the study medication, arrangements will be made to provide infusions on an out-patient basis or home infusion.
During each week of treatment, you will be asked about any symptoms or illnesses that you have experienced. In addition, you will be asked to inform the study doctor and/or study staff of any medications or therapies that you are taking while on study. You will be taken off study if the infection gets worse or intolerable side effects occur.
Participation on this study will last for a no more than 60 days. If you have been discharged from the hospital, the end of treatment visit will take place within 7 -14 days of the last day of study drug. You will need to return for the visit on an outpatient basis.
At this visit, you will have a physical exam, including measurement of vital signs (heart rate, temperature, and blood pressure). Blood samples (about 1 tablespoon) will be drawn for routine test and to check for infection. The blood sample may be drawn from the CVC, if the CVC is still in place. The CVC exit site will be examined. You will be asked about any symptoms or illnesses that you may have experienced. In addition, you will be asked to inform the study doctor and/or study staff of any medications or therapies that you are taking.
You will have a follow-up exam between 32 (+/- 7) days after your last dose of study drug. You will have a physical exam, including measurement of vital signs (heart rate, temperature, and blood pressure). Blood (about one tablespoon) will be drawn for routine tests and to check for infection. The blood samples may be drawn from the CVC, if the CVC is still in place. The CVC exit site may be examined. You will be asked about any symptoms or illnesses that you may have experienced. In addition, you will be asked to inform the study doctor and/or study staff of any medications or therapies that you are taking. Participation on this study will end once you complete the follow-up visit.
This is an investigational study. Daptomycin is approved by the FDA for the treatment of skin and soft tissue infection. However, for the use described in this study and at this dose level, Daptomycin is authorized by the FDA for use in research only. About 50 patients will take part in this study. All will be enrolled at the University of Texas (UT) MD Anderson Cancer Center (MDACC).
- Conditions
- Staphylococcus Aureus
- Being tested
- Daptomycin
- Keywords
- Catheter-Related Infection, Bloodstream Infections, Staphylococcus Aureus, Daptomycin
- Medical subject headings
- Staphylococcal Infections, Catheter-Related Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
Also called Cubicin
6mg/kg/day IV for at least 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Daptomycin | Experimental | 6mg/kg/day intravenous (IV) for 10 days Receives: Drug: Daptomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response Rate
Clinical response of Daptomycin administered for treatment of catheter-related bloodstream infections due to Staphylococcus Aureus bacteria, evaluated within 7 weeks of initiating Daptomycin therapy.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study startMay 2006
- Primary completionOct 2007
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Responsible party
- Sponsor
- Investigators
- Issam Raad, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507247
- Sponsor's protocol ID
- 2005-0622
- Other IDs
- NCI-2010-00722
- Status last verified
- Nov 2014
- First submitted
- 24 Jul 2007
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open-Label Study to Evaluate the Safety and Efficacy of Daptomycin in the Treatment of Catheter-Related Staphylococcus Aureus Bloodstream Infections
- ClinicalTrials.gov ID
- NCT00507247
- Acronym / sponsor ID
- 2005-0622
- Conditions
- Staphylococcus Aureus
- Keywords
- Catheter-Related Infection, Bloodstream Infections, Staphylococcus Aureus, Daptomycin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Study start
- May 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 26 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
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 central venous catheter (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).
Detailed description
Daptomycin is a new antibiotic. It may be effective against a variety of bacterial infections that are difficult to treat.
Aztreonam, Cefepime, Carbapenems and Augmentin are antibiotics that are used to treat certain types of bacteria.
If you are found to be eligible to take part in this study, you will be given daptomycin by vein for at least 10 days, depending on your certain type of bacteria. You will receive Daptomycin by vein for 30 minutes every 24 hours.
The CVC associated with CRBSI (catheter-related bloodstream infection = CR-BSI) from all enrolled patients will either be removed or be exchanged over guide wire for a new CVC within 96 hours of onset of the first blood culture. Your primary doctor will decide whether to remove or exchange the CVC with the willingness of you.
If the study doctor and/or your primary physician knows or thinks that you have a mixed infection (both "gram positive" and "gram negative") or may have infection in lungs (pneumonia), you may also be treated with the antibiotic drugs Aztreonam, Cefepime, Carbapenems, or Augmentin by vein or by mouth in combination with the study drug Daptomycin.
During each week of treatment, blood (about 1 tablespoon) will be drawn for routine lab tests. The blood sample may be drawn from the CVC, if the CVC is still in place. In addition, blood (about 1 tablespoon) will be drawn every other day until it no longer shows signs of infection. The catheter exit site may be examined at each visit until you have no more signs or symptoms of infection. If you are discharged from the hospital before completing the study medication, arrangements will be made to provide infusions on an out-patient basis or home infusion.
During each week of treatment, you will be asked about any symptoms or illnesses that you have experienced. In addition, you will be asked to inform the study doctor and/or study staff of any medications or therapies that you are taking while on study. You will be taken off study if the infection gets worse or intolerable side effects occur.
Participation on this study will last for a no more than 60 days. If you have been discharged from the hospital, the end of treatment visit will take place within 7 -14 days of the last day of study drug. You will need to return for the visit on an outpatient basis.
At this visit, you will have a physical exam, including measurement of vital signs (heart rate, temperature, and blood pressure). Blood samples (about 1 tablespoon) will be drawn for routine test and to check for infection. The blood sample may be drawn from the CVC, if the CVC is still in place. The CVC exit site will be examined. You will be asked about any symptoms or illnesses that you may have experienced. In addition, you will be asked to inform the study doctor and/or study staff of any medications or therapies that you are taking.
You will have a follow-up exam between 32 (+/- 7) days after your last dose of study drug. You will have a physical exam, including measurement of vital signs (heart rate, temperature, and blood pressure). Blood (about one tablespoon) will be drawn for routine tests and to check for infection. The blood samples may be drawn from the CVC, if the CVC is still in place. The CVC exit site may be examined. You will be asked about any symptoms or illnesses that you may have experienced. In addition, you will be asked to inform the study doctor and/or study staff of any medications or therapies that you are taking. Participation on this study will end once you complete the follow-up visit.
This is an investigational study. Daptomycin is approved by the FDA for the treatment of skin and soft tissue infection. However, for the use described in this study and at this dose level, Daptomycin is authorized by the FDA for use in research only. About 50 patients will take part in this study. All will be enrolled at the University of Texas (UT) MD Anderson Cancer Center (MDACC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daptomycin | Experimental | Drug: Daptomycin6mg/kg/day intravenous (IV) for 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or non-pregnant, non-lactating females with an age of greater than or equal to 18 years.
- The suspected culprit on exchangeable central venous catheter (CVC) is tunnel ( including implanted ports) or non-tunneled catheter, antibiotic or non-antibiotic coated catheter inserted in the subclavian, jugular or femoral vein.
- 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 axillary add 0.5 degrees C to the measured temperature; (b) Pulse rate =/> 100 beats/min.; (c) Respiratory rate =/> 20/min; (d) white blood count (WBC) count =/>12,000/mm^3 or =/<4,000/mm^3 differential count showing >10% band forms; (e) Systolic blood pressure=/ <90 mm Hg
- 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)
- Signed informed consent
Key exclusion criteria (16 listed)
- Creatinine clearance <30 mL/min at the time gram positive bacteremia was diagnosed unless the patient is on dialysis
- Bilirubin >4 times the upper limit of normal at the time gram positive bacteremia was diagnosed
- 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.
- Documented S. aureus bacteremia within last 3 months due to source other than CVC.
- Patients who have participated in another investigational anti-infective study within 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaptomycinAlso: Cubicin6mg/kg/day IV for at least 10 days. | Drug | Daptomycin |
Primary outcome
Clinical Response Rate
Time frame: 7 weeks
Clinical response of Daptomycin administered for treatment of catheter-related bloodstream infections due to Staphylococcus Aureus bacteria, evaluated within 7 weeks of initiating Daptomycin therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Staphylococcus Aureus
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Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
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A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Issam Raad, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daptomycin in people with Staphylococcus Aureus, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Response Rate (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016.