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Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis

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ClinicalTrials.gov Identifier: NCT01420562
Recruitment Status : Unknown
Verified February 2013 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : August 19, 2011
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Tracking Information
First Submitted Date August 16, 2011
First Posted Date August 19, 2011
Last Update Posted Date January 14, 2015
Study Start Date September 2011
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 13, 2015)
Posaconazole plasma levels and area under the curve in patients with different stages of mucositis [ Time Frame: Day 0 (day of transplantation), day +7, day +14 ]
Plasma levels of posaconazole will be determined to calculate the area under the curve. These values will be correlated with the stage of mucositis, which will be assessed using citrulline monitoring in plasma. The stage of mucositis will also be assessed using the Daily Oral Mucositis Score (DMS) and Daily Gut Mucositis Score (DGS).
Original Primary Outcome Measures
 (submitted: August 18, 2011)
Posaconazole plasma levels and area under the curve in patients with different stages of mucositis [ Time Frame: Day 0 (day of transplantation), day +7 and day +14 ]
Plasma levels of posaconazole will be determined to calculate the area under the curve. These values will be correlated with the stage of mucositis, which will be assessed using citrulline monitoring in plasma. The stage of mucositis will also be assessed using the Daily Oral Mucositis Score (DMS) and Daily Gut Mucositis Score (DGS).
Change History Complete list of historical versions of study NCT01420562 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis
Official Title Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis
Brief Summary The goal of this study is to calculate pharmacokinetic parameters and to evaluate the trough levels of posaconazole reached in patients with different stages of mucositis, due to chemotherapy and total body irradiation.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients on the hematology ward who will receive an allogeneic stem cell transplantation.
Condition Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Intervention Procedure: blood sampling
During posaconazole treatment, blood sampling will occur on day 0 (=day of transplantation), day 7 and 14 to correlate posaconazole exposure to severity of mucositis.
Study Groups/Cohorts
  • Posaconazole oral suspension

    One group of patients will receive posaconazole oral suspension as prophylactic agent.

    Blood sampling: At day of transplantation, day 7 and 14, 9 blood samples will be collected to calculate AUC. Moreover, citrulline will be determined to objectively evaluate the severity of mucositis.

    Intervention: Procedure: blood sampling
  • Posaconazole oral tablet

    Once the oral tablet is available for adminstration to patients, a second group of patients will receive these tablets as prophylactic agent.

    Blood sampling: At day of transplantation, day 7 and 14, 9 blood samples will be collected to calculate AUC. Moreover, citrulline will be determined to objectively evaluate the severity of mucositis.

    Intervention: Procedure: blood sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 13, 2015)
55
Original Estimated Enrollment
 (submitted: August 18, 2011)
20
Study Completion Date Not Provided
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients receiving allogeneic stem cell transplantation - Treated with prophylactic posaconazole: oral suspension (200mg three times daily) or tablet (300mg once daily) to prevent invasive fungal infections

Exclusion Criteria:

  • Gastroparesis
  • Vomiting or diarrhea within 2 hours after intake of posaconazole
  • Concomitant administration of potent inducers of the enzyme UGT1A4: carbamazepine,phenytoin, phenobarbital, rifabutin, rifampicin,...
  • Age under 18 years
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT01420562
Other Study ID Numbers ML7267
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Universitaire Ziekenhuizen Leuven
Study Sponsor Universitaire Ziekenhuizen Leuven
Collaborators Not Provided
Investigators
Principal Investigator: Kim Vanstraelen, R.Ph. Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date February 2013