Bloodstream InfectionPhase 2NCT00467272
Catheter Related - Gram Positive Bloodstream Infections
A Phase 2 study testing Daptomycin in people with Bloodstream Infection, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: -Evaluate the clinical efficacy and safety of Daptomycin given for treatment of catheter-related bloodstream infections (CRBSI) due to gram positive bacteremia in the context of standard of care antimicrobial therapy consisting mainly of Vancomycin with or without initial treatment with beta lactam… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bloodstream Infection
- 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
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 tunneled or non-tunnel (including ports and PICC) and antibiotic or non-antibiotic coated catheter inserted in the subclavian, jugular, peripheral 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, tympanic ally or via a central catheter. If auxiliary add 0.5 degrees C to the measured temperature; b. Pulse rate =/> 100 beats/min.; c. Respiratory rate =/> 20/min.; d. white blood cell (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 probable or definite diagnosis of uncomplicated CVC-related gram positive bacteremia that includes at least one positive blood culture for Coagulase Negative Staphylococci (CNS), Staphylococcus aureus (SA), Enterococci, Corynebacterium, and Propionibacterium (If the positive blood culture is drawn through the CVC for skin flora such as CNS, Corynebacterium, Propionibacterium, Micrococcus and Bacillus, then at least >15 colonies/ml will be required or the 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 (may have local signs and symptoms at the catheter site).
Who cannot join
- Estimated Serum Creatinine Clearance <30 mL/min (according to Cock-Gault-formula)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, such as vancomycin, linezolid, tigecycline or daptomycin, effective against resistant gram positive bacterial infections, such as methicillin resistant staphylococci, for more than 48 hours within 72 hours of study medication initiation, unless treatment failed that is defined as a persistent fever, leukocytosis, and/or repeated positive blood cultures (CVC and peripheral) for 72 hours or longer of appropriate antibiotics treatment other than Daptomycin.
- Documented gram positive bacteremia within last 1 month 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 13Show 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.
- Prosthetic valve.
- 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).
- Patients with diagnosis of pneumonia that is due to S. aureus organism, e.g, S. aureus from sputum or bronchial cultures.
- 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.
About this study
Official title: Phase II, Open-Label Study to Evaluate the Safety and Efficacy of Daptomycin in the Treatment of Catheter-Related Gram Positive Bloodstream Infections
Primary Objective:
-Evaluate the clinical efficacy and safety of Daptomycin given for treatment of catheter-related bloodstream infections (CRBSI) due to gram positive bacteremia in the context of standard of care antimicrobial therapy consisting mainly of Vancomycin with or without initial treatment with beta lactam antibiotics.
Read the detailed description
THE STUDY DRUG:
Daptomycin is an antibiotic designed to treat a variety of bacterial infections that are difficult to treat.
STUDY TREATMENT:
If you are found to be eligible to take part in this study, you will be given daptomycin by vein over 30 minutes every 24 hours for at least 7-14 days, depending on the type of bacteria that you have.
The central venous catheter (CVC) will either be removed, or it will be exchanged over a guide wire. The decision to remove or exchange the CVC and timing of the placement of the CVC will be decided by your primary physician and the willingness of you to remove or exchange your infected CVC. This will be done within 96 hours after your first positive blood culture (first blood drawn that showed bacteria). A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure.
If the study doctor and/or your primary doctor suspects that you have a mixed infection (2 or more certain types of bacteria) or pneumonia, you will also be treated with different types of antibiotics, by vein or mouth, in combination with the study drug. These antibiotics may include aztreonam, cefepime, imipenem, meropenem, ciprofloxacin hydrochloride, bactrim, and/or amoxicillin/clavulanate (a combination antibiotic).
If you are discharged from the hospital before completing the study medication, arrangements will be made to provide infusions on an outpatient basis (by a nurse, yourself, or a family member). You and/or a family member will be taught (by a nurse) how to take the study medication at home. Before you are discharged from the hospital, you will receive the kits that include enough supplies for you and/or a family member to give daptomycin by vein. If medication will be given at home, a prescription will be given to you to pick up your medication from the pharmacy before you discharge from the hospital. If possible, your primary doctor may arrange for you to receive medication at the M. D. Anderson outpatient treatment center, or a nurse will be scheduled to visit you at home to give you the medication.
STUDY TESTS/PROCEDURES:
During each week of treatment, you will have the following exams/procedures performed once a week.
- You will have blood drawn (about 1 tablespoon) for routine tests. It may be drawn from the CVC, if the CVC is still in place. The CVC exit site will be examined at each visit until you have no more signs or symptoms of infection.
- You will also have blood drawn (about 1 tablespoon) for a blood culture every other day until it no longer shows signs of infection.
- You will be asked about any symptoms or illnesses that you may have experienced since your last visit.
LENGTH OF STUDY:
Participation on this study will last for no more than 60 days (about 2 months).
- Conditions
- Bloodstream Infection
- Being tested
- Daptomycin
- Keywords
- Catheter-Related Bloodstream Infections, Bloodstream Infection, Daptomycin, Cubicin, CRBSI
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
Also called Cubicin
6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for SA and at least 7 days for enterococci and CNS, Corynebacterium, and Propionibacterium.
| Study group | Role | What they receive |
|---|---|---|
| Daptomycin | Experimental | Daptomycin 6 mg/kg intravenous (IV) every 24 hours for at least 7-14 days, depending on the type of bacteria. Receives: Drug: Daptomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response Within 48 Hours
Number of participants with clinical response within 48 hours from initiation of Daptomycin, estimated by Bayesian posterior credible interval. Clinical response defined as resolution of clinical signs and symptoms within 48 hours from initiating the study drug.
Measured: Within 48 hours from initiating the study drug
Clinical Response Within 7 Days
Number of participants with clinical response within 1 week from initiation of Daptomycin, estimated by Bayesian posterior credible interval. Clinical response defined as resolution of clinical signs and symptoms within 7 days from initiating the study drug.
Measured: Within 7 days from initiating the study drug
Microbiological Response Within 48 Hours
Number of participants with microbiological response within 48 hours from initiation of Daptomycin. Microbiological response defined as eradication of the microorganism from the bloodstream (negative blood cultures).
Measured: Within 48 hours from initiating the study drug
Microbiological Response Within 7 Days
Number of participants with microbiological response within 7 days from initiation of Daptomycin. Microbiological response defined as eradication of the microorganism from the bloodstream (negative blood cultures).
Measured: Within 7 days from initiating the study drug
Secondary outcomes (2)
Relapse
Number of participants with relapse was defined as the recurrence of bacteremia within the first 3 months.
Measured: Within 3 months from initiating the study drug
Number of Participants With Overall Response
Overall response = symptom resolution within 3 days (since using antibiotic) + microbiological resolution within 3 days + no infection-related death + no infection-related late complications + no relapse. Infection-related late complication was defined as the development of deep-seated infection that was not present or suspected at the onset of bacteremia but was subsequently diagnosed after 1 week from initiation of study drug.
Measured: Within 3 days from initiating the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bloodstream InfectionStudies 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
- 30 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
- NCT00467272
- Sponsor's protocol ID
- 2006-0958
- Status last verified
- Jan 2021
- First submitted
- 26 Apr 2007
- Last updated
- 8 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. 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 Gram Positive Bloodstream Infections
- ClinicalTrials.gov ID
- NCT00467272
- Acronym / sponsor ID
- 2006-0958
- Conditions
- Bloodstream Infection
- Keywords
- Catheter-Related Bloodstream Infections, Bloodstream Infection, Daptomycin, Cubicin, CRBSI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 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
- Mar 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Apr 2007 (estimated)
- Results
- Posted 8 Feb 2021
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 clinical efficacy and safety of Daptomycin given for treatment of catheter-related bloodstream infections (CRBSI) due to gram positive bacteremia in the context of standard of care antimicrobial therapy consisting mainly of Vancomycin with or without initial treatment with beta lactam antibiotics.
Detailed description
THE STUDY DRUG:
Daptomycin is an antibiotic designed to treat a variety of bacterial infections that are difficult to treat.
STUDY TREATMENT:
If you are found to be eligible to take part in this study, you will be given daptomycin by vein over 30 minutes every 24 hours for at least 7-14 days, depending on the type of bacteria that you have.
The central venous catheter (CVC) will either be removed, or it will be exchanged over a guide wire. The decision to remove or exchange the CVC and timing of the placement of the CVC will be decided by your primary physician and the willingness of you to remove or exchange your infected CVC. This will be done within 96 hours after your first positive blood culture (first blood drawn that showed bacteria). A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure.
If the study doctor and/or your primary doctor suspects that you have a mixed infection (2 or more certain types of bacteria) or pneumonia, you will also be treated with different types of antibiotics, by vein or mouth, in combination with the study drug. These antibiotics may include aztreonam, cefepime, imipenem, meropenem, ciprofloxacin hydrochloride, bactrim, and/or amoxicillin/clavulanate (a combination antibiotic).
If you are discharged from the hospital before completing the study medication, arrangements will be made to provide infusions on an outpatient basis (by a nurse, yourself, or a family member). You and/or a family member will be taught (by a nurse) how to take the study medication at home. Before you are discharged from the hospital, you will receive the kits that include enough supplies for you and/or a family member to give daptomycin by vein. If medication will be given at home, a prescription will be given to you to pick up your medication from the pharmacy before you discharge from the hospital. If possible, your primary doctor may arrange for you to receive medication at the M. D. Anderson outpatient treatment center, or a nurse will be scheduled to visit you at home to give you the medication.
STUDY TESTS/PROCEDURES:
During each week of treatment, you will have the following exams/procedures performed once a week.
- You will have blood drawn (about 1 tablespoon) for routine tests. It may be drawn from the CVC, if the CVC is still in place. The CVC exit site will be examined at each visit until you have no more signs or symptoms of infection.
- You will also have blood drawn (about 1 tablespoon) for a blood culture every other day until it no longer shows signs of infection.
- You will be asked about any symptoms or illnesses that you may have experienced since your last visit.
LENGTH OF STUDY:
Participation on this study will last for no more than 60 days (about 2 months).
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: DaptomycinDaptomycin 6 mg/kg intravenous (IV) every 24 hours for at least 7-14 days, depending on the type of bacteria. |
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 tunneled or non-tunnel (including ports and PICC) and antibiotic or non-antibiotic coated catheter inserted in the subclavian, jugular, peripheral 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, tympanic ally or via a central catheter. If auxiliary add 0.5 degrees C to the measured temperature; b. Pulse rate =/> 100 beats/min.; c. Respiratory rate =/> 20/min.; d. white blood cell (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 probable or definite diagnosis of uncomplicated CVC-related gram positive bacteremia that includes at least one positive blood culture for Coagulase Negative Staphylococci (CNS), Staphylococcus aureus (SA), Enterococci, Corynebacterium, and Propionibacterium (If the positive blood culture is drawn through the CVC for skin flora such as CNS, Corynebacterium, Propionibacterium, Micrococcus and Bacillus, then at least >15 colonies/ml will be required or the time of positive (DTP) of CVC at least 2 hours earlier than the peripheral culture).
- Signed informed consent.
Key exclusion criteria (13 listed)
- Estimated Serum Creatinine Clearance <30 mL/min (according to Cock-Gault-formula)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, such as vancomycin, linezolid, tigecycline or daptomycin, effective against resistant gram positive bacterial infections, such as methicillin resistant staphylococci, for more than 48 hours within 72 hours of study medication initiation, unless treatment failed that is defined as a persistent fever, leukocytosis, and/or repeated positive blood cultures (CVC and peripheral) for 72 hours or longer of appropriate antibiotics treatment other than Daptomycin.
- Documented gram positive bacteremia within last 1 month 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: Cubicin6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for SA and at least 7 days for enterococci and CNS, Corynebacterium, and Propionibacterium. | Drug | Daptomycin |
Primary outcome
Clinical Response Within 48 Hours
Time frame: Within 48 hours from initiating the study drug
Number of participants with clinical response within 48 hours from initiation of Daptomycin, estimated by Bayesian posterior credible interval. Clinical response defined as resolution of clinical signs and symptoms within 48 hours from initiating the study drug.
Clinical Response Within 7 Days
Time frame: Within 7 days from initiating the study drug
Number of participants with clinical response within 1 week from initiation of Daptomycin, estimated by Bayesian posterior credible interval. Clinical response defined as resolution of clinical signs and symptoms within 7 days from initiating the study drug.
Microbiological Response Within 48 Hours
Time frame: Within 48 hours from initiating the study drug
Number of participants with microbiological response within 48 hours from initiation of Daptomycin. Microbiological response defined as eradication of the microorganism from the bloodstream (negative blood cultures).
Microbiological Response Within 7 Days
Time frame: Within 7 days from initiating the study drug
Number of participants with microbiological response within 7 days from initiation of Daptomycin. Microbiological response defined as eradication of the microorganism from the bloodstream (negative blood cultures).
2 secondary outcomes
Relapse
Time frame: Within 3 months from initiating the study drug
Number of Participants With Overall Response
Time frame: Within 3 days from initiating the study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center Official WebsiteLink provided by the sponsor.
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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 Bloodstream Infection, 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 13 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 8 Feb 2021. 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?
Yes. Results are posted in the registry (first posted 8 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Within 48 Hours (time frame: Within 48 hours from initiating the study drug). The study lists 4 primary outcomes in all. 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 8 Feb 2021.