Suspended

PAPALPosaconazole Levels in Lung Transplant Recipients for Infection Prevention

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What is being tested

Posaconazole

+ Calogen®

+ Posaconazole

Drug
Who is being recruted

Bacterial Infections and Mycoses

+ Infections

+ Mycoses

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 4
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC
Last updated: October 9, 2018
Sourced from a government-validated database.Claim as a partner

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.

NCT01667107
Principal SponsorMerck Sharp & Dohme LLC
Last updated: October 9, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

26 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Bacterial Infections and MycosesInfectionsMycoses

Criteria

3 inclusion criteria required to participate
Able to take oral/nasogastric medication

Females of childbearing potential, males, and the sexual partners of males must use an effective method of birth control during this study and for 6 weeks after completing the study

Scheduled to undergo lung transplantation

4 exclusion criteria prevent from participating
Breastfeeding

Current use of cytochrome P-450 (CYP)-3A4 inhibitors including terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine within 7 days before transplant

Severe liver disease

Treatment with posaconazole within 14 days before transplant

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.

Group II

Experimental
Posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers