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NCT Number: NCT00138112

Trial of Prophylactic Versus Empirical Vancomycin for the Prevention of 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.

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Key information

Conditions

Streptococcal Sepsis Hematologic Diseases Hematologic Malignancies Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Empirical Vancomycin

Drug

Prophylactic Vancomycin

Drug

Primary outcomes

  1. To compare prophylactic with empirical vancomycin administration for reducing early viridans streptococcal bacteremia in allogeneic hematopoietic stem cell transplant (HSCT) patients

Secondary outcomes

  1. To examine the safety and tolerability for each vancomycin administration approach

  2. To measure the incidence of vancomycin-resistant enterococcal (VRE) infections for patients managed with each of the two vancomycin administration approaches

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Randomized Trial of Prophylactic Versus Empirical Vancomycin for the Prevention of Early Viridans Streptococcal Sepsis After Hematopoietic Cell Transplantation

Important dates

Study start
2003
Study completion
2005
First posted
Aug 30, 2005
Registry last updated
Sep 8, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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