PAPALPosaconazole Levels in Lung Transplant Recipients for Infection Prevention
Posaconazole
+ Calogen®
+ Posaconazole
Bacterial Infections and Mycoses
+ Infections
+ Mycoses
Prevention Study
Summary
Study start date: January 23, 2013
Actual date on which the first participant was enrolled.This study focuses on lung transplant recipients, specifically those with and without cystic fibrosis (CF). The main goal is to understand how a drug called posaconazole behaves in their bodies, particularly in the plasma and the alveolar compartment (AC) of the lungs. Posaconazole is an antifungal medication given routinely after transplantation to prevent fungal infections. By studying its behavior, the research aims to improve post-transplant care and reduce the risk of fungal infections in these patients. During the study, participants receive posaconazole as part of their routine post-operative care. To measure the drug's concentration, samples are taken from both the plasma and the lungs during any clinically-indicated bronchoscopy, a procedure where a thin tube is inserted into the lungs. Participants may have more than one bronchoscopy. Additionally, blood samples are collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. These samples help determine the time it takes for the drug to reach 90% of its steady state concentration in the serum, providing valuable insights into how quickly the drug becomes effective.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.26 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives