Streptococcal SepsisPhase 3NCT00138112
Trial of Prophylactic Versus Empirical Vancomycin for the Prevention of Streptococcal Sepsis After Hematopoietic Cell Transplantation
A Phase 3 study testing Empirical Vancomycin and Prophylactic Vancomycin in people with Streptococcal Sepsis and Hematologic Malignancies, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This is a randomized 2-arm study to compare two different times of giving the drug vancomycin. Half of the patients will begin vancomycin two days before a bone marrow transplant. The other half will get it as soon as they have the first fever. Streptococci are bacteria that live in one's mouth and gut. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Streptococcal Sepsis, Hematologic Malignancies
- What is being tested?
- Empirical Vancomycin and Prophylactic Vancomycin
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Nov 2005
- Phase
- Phase 3
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
- Adult patients undergoing allogeneic HSCT for hematologic malignancies or other disorders
- Conditioning regimen that includes high-dose total body irradiation (TBI) (>1200 cGy)
- The ability to understand and the willingness to sign the Institutional Review Board (IRB)-approved Informed Consent, including the Research Authorization component of the Informed Consent form.
Who cannot join
- Non-TBI conditioning regimen
- Prior history of hypersensitivity to vancomycin (excluding history of "Red Man Syndrome")
- Fever or infection that requires intravenous vancomycin or oral/intravenous linezolid between day-7 and day-3 before hematopoietic stem cell transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Randomized Trial of Prophylactic Versus Empirical Vancomycin for the Prevention of Early Viridans Streptococcal Sepsis After Hematopoietic Cell Transplantation
This is a randomized 2-arm study to compare two different times of giving the drug vancomycin. Half of the patients will begin vancomycin two days before a bone marrow transplant. The other half will get it as soon as they have the first fever.
Streptococci are bacteria that live in one's mouth and gut. These bacteria can escape into the blood when the lining of the mouth and gut weakens from cancer therapy. This can make the person who is undergoing a bone marrow transplant very sick. All patients who get this infection are treated with antibiotics. Vancomycin is one drug that is used to treat this bloodstream infection once it is diagnosed. Studies have shown that giving vancomycin before a bone marrow transplant seems to prevent this infection. However, giving vancomycin too soon may increase the chance that the kidneys will be irritated. It may also increase the chance that other bacteria will become resistant to this drug. We, the investigators at Memorial Sloan-Kettering Cancer Center, do not know if waiting to start vancomycin until the patient has a first fever can also prevent this infection.
Read the detailed description
The primary objective of this study is as follows:
- To compare prophylactic with empirical vancomycin administration for reducing early viridans streptococcal bacteremia in allogeneic hematopoietic stem cell transplant (HSCT) patients.
The secondary objectives of the study are:
- To examine the safety and tolerability for each vancomycin administration approach.
- To measure the incidence of vancomycin-resistant enterococcal (VRE) infections for patients managed with each of the two vancomycin administration approaches.
- Conditions
- Streptococcal Sepsis, Hematologic Malignancies
- Being tested
- Empirical Vancomycin, Prophylactic Vancomycin
- Keywords
- Streptococcal Sepsis, Hematopoietic Stem Cell Transplantation, Hematologic Malignancies, Streptococci, Transplant
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empirical VancomycinDrug
Prophylactic VancomycinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare prophylactic with empirical vancomycin administration for reducing early viridans streptococcal bacteremia in allogeneic hematopoietic stem cell transplant (HSCT) patients
Secondary outcomes (2)
To examine the safety and tolerability for each vancomycin administration approach
To measure the incidence of vancomycin-resistant enterococcal (VRE) infections for patients managed with each of the two vancomycin administration approaches
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startNov 2003
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcal SepsisStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Susan Seo, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138112
- Sponsor's protocol ID
- 03-142
- Status last verified
- Sep 2006
- First submitted
- 26 Aug 2005
- Last updated
- 8 Sep 2006
- Results posted
- No