Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177723
Status:
COMPLETED
Last Update Posted:
2008-12-17
First Post:
2005-09-13
Brief Title:
Towards Reducing Resistance and Hematological Toxicity of Linezolid
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Towards Reducing Resistance and Hematological Toxicity of Linezolid
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will evaluate and improve the performance of pharmaco-statistical models previously developed in the compassionate use program in patients being treated with linezolid under clinical usage conditions This study will also develop a sensitive and specific tool that may be used to predict patients at risk of hematological toxicity based on factors including linezolid concentration and duration of therapy and use these models to better understand the determinants of toxicity with linezolid and define better strategies to manage toxicity or reduce its occurrence
Detailed Description:
Epidemiologic information to be collected
At baseline upon signing informed consent the following information will be collected Demographic data - age sex height weight state of birth previous pathology reports associated with the bacteria the subject has contracted laboratory results current medication use and any other prior medical problemshistory The following outcome measures will be assessed a time to resolution of fever b time to normalization of white blood cell count c time to microbiologic eradication of infection d mortality at 28 days following onset of infection
Blood work to be collected
Hematological parameters
Patients included in this study will be required to have blood samples taken to determine their platelet count and hemoglobin at baseline prior to the first dose of linezolid weekly whilst receiving linezolid and at end of linezolid treatment Monitoring of hematological parameters is recommended as part of the standard of care for patients being treated with linezolid for greater than 2 weeks This information will be collected from the participants medical record and become part of the research record
Pharmacokinetic samples
On doses 4 or 5 of Linezolid administration blood samples will be obtained from the patients vein prior to the first dose of the day of intravenous IV or oral Linezolid Subsequent samples of blood will be obtained over an eight hour period following dose administration 2 hours 4 hours and 8 hours after dose administration About 5 ml or one teaspoon will be obtained by the bedside nurse for each blood sample for a total of 20 ml or 4 teaspoonfuls The GCRC staff will travel to the patients hospital unit and obtain the blood samples when necessary If the patient is an outpatient the patient will be asked to come to the GCRC to have the blood samples withdrawn
If the samples are not obtained prior to the first dose of medicine on days 2 or 3 of dose administration blood can be obtained from the patients vein around two separate doses on day 2 and 3 and day 3 and 4 Blood will be obtained from the patients vein prior to taking the next dose of IV or oral Linezolid and two hours after the medicine has been administered About 10 ml or two teaspoonfuls will be obtained by the bedside nurse for each blood sample for a total of 20 ml or 4 teaspoonfuls
If the patient develops a decrease in hematologic parameters defined as Hb 10 gdL WBC 25 ANC 15 or platelets 100 blood will be collected from the patients vein immediately before a linezolid dose and two hours after the medicine has been administered At these levels the clinicians caring for the patient will be advised that the frequency of hematologic monitoring should increase to three times weekly If the following hematologic parameters occur the clinician will be advised by the investigators to consider utilizing an alternative antibiotic Hb 8 mgdL WBC 15 ANC 10 platelets 50 It is acknowledged that the investigators are not responsible for the care of the patient and that many factors may influence the clinicians decision to continue or to switch linezolid therapy The management decisions will be made by the patients clinical team and NOT the investigators
The blood samples will be processed and stored in a - 80 C freezer in a secured laboratory under the supervision of the principal investigator These samples will then be used to determine the amount of Linezolid that reached the participants blood following dose administration
All samples will be analyzed to obtain the amount of Linezolid found in the blood No genetic testing will be performed on any of the samples being obtained The biologic samples blood will be under the control of the principal investigator of this research project To protect confidentiality all personal identifiers ie name social security number and birth date will be removed de-identified and replaced with a specific code number The information linking these code numbers to the corresponding subjects identities will be kept in a separate secure location The investigators on this study will keep the samples indefinitely Part of the biologic samples will be sent to Dr Craig Rayner at Monash University of Australia All samples sent outside of the UPMC facility will be de-identified Samples sent to Monash University will be kept in Dr Rayners laboratory If a subject withdraws and provides the request in writing samples collected and not already processed will be destroyed All samples at UPMC will be kept in the investigators laboratory located in Scaife Hall Room 812 3550 Terrace Street
All patients will be seen at the UPMC facility while they are inpatients
If a subject is removed from Linezolid clinically subjects will not be required to prolong the use of Linezolid and the subjects hospitalization will not be prolonged if not clinically indicated
At baseline upon signing informed consent the following information will be collected Demographic data - age sex height weight state of birth previous pathology reports associated with the bacteria the subject has contracted laboratory results current medication use and any other prior medical problemshistory The following outcome measures will be assessed a time to resolution of fever b time to normalization of white blood cell count c time to microbiologic eradication of infection d mortality at 28 days following onset of infection
Blood work to be collected
Hematological parameters
Patients included in this study will be required to have blood samples taken to determine their platelet count and hemoglobin at baseline prior to the first dose of linezolid weekly whilst receiving linezolid and at end of linezolid treatment Monitoring of hematological parameters is recommended as part of the standard of care for patients being treated with linezolid for greater than 2 weeks This information will be collected from the participants medical record and become part of the research record
Pharmacokinetic samples
On doses 4 or 5 of Linezolid administration blood samples will be obtained from the patients vein prior to the first dose of the day of intravenous IV or oral Linezolid Subsequent samples of blood will be obtained over an eight hour period following dose administration 2 hours 4 hours and 8 hours after dose administration About 5 ml or one teaspoon will be obtained by the bedside nurse for each blood sample for a total of 20 ml or 4 teaspoonfuls The GCRC staff will travel to the patients hospital unit and obtain the blood samples when necessary If the patient is an outpatient the patient will be asked to come to the GCRC to have the blood samples withdrawn
If the samples are not obtained prior to the first dose of medicine on days 2 or 3 of dose administration blood can be obtained from the patients vein around two separate doses on day 2 and 3 and day 3 and 4 Blood will be obtained from the patients vein prior to taking the next dose of IV or oral Linezolid and two hours after the medicine has been administered About 10 ml or two teaspoonfuls will be obtained by the bedside nurse for each blood sample for a total of 20 ml or 4 teaspoonfuls
If the patient develops a decrease in hematologic parameters defined as Hb 10 gdL WBC 25 ANC 15 or platelets 100 blood will be collected from the patients vein immediately before a linezolid dose and two hours after the medicine has been administered At these levels the clinicians caring for the patient will be advised that the frequency of hematologic monitoring should increase to three times weekly If the following hematologic parameters occur the clinician will be advised by the investigators to consider utilizing an alternative antibiotic Hb 8 mgdL WBC 15 ANC 10 platelets 50 It is acknowledged that the investigators are not responsible for the care of the patient and that many factors may influence the clinicians decision to continue or to switch linezolid therapy The management decisions will be made by the patients clinical team and NOT the investigators
The blood samples will be processed and stored in a - 80 C freezer in a secured laboratory under the supervision of the principal investigator These samples will then be used to determine the amount of Linezolid that reached the participants blood following dose administration
All samples will be analyzed to obtain the amount of Linezolid found in the blood No genetic testing will be performed on any of the samples being obtained The biologic samples blood will be under the control of the principal investigator of this research project To protect confidentiality all personal identifiers ie name social security number and birth date will be removed de-identified and replaced with a specific code number The information linking these code numbers to the corresponding subjects identities will be kept in a separate secure location The investigators on this study will keep the samples indefinitely Part of the biologic samples will be sent to Dr Craig Rayner at Monash University of Australia All samples sent outside of the UPMC facility will be de-identified Samples sent to Monash University will be kept in Dr Rayners laboratory If a subject withdraws and provides the request in writing samples collected and not already processed will be destroyed All samples at UPMC will be kept in the investigators laboratory located in Scaife Hall Room 812 3550 Terrace Street
All patients will be seen at the UPMC facility while they are inpatients
If a subject is removed from Linezolid clinically subjects will not be required to prolong the use of Linezolid and the subjects hospitalization will not be prolonged if not clinically indicated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None