A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105)

Fungal Infection Clinical Trial

— PAPAL  

Official title:

A Pharmacokinetic Analysis of Posaconazole in the Plasma and Alveolar Compartment of Lung Transplant Recipients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01667107
• Other study ID #: 5592-105
• Secondary ID: 2012-003140-68
• Status: Terminated
• Phase: Phase 4
• Start date: January 23, 2013
• Est. completion date: January 16, 2014

Study information

• Verified date: September 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This single site study will examine plasma and alveolar compartment (AC) levels of posaconazole in cystic fibrosis (CF) and non-cystic fibrosis (non-CF) lung transplant recipients receiving routine post-operative anti-fungal prophylaxis. Invasive fungal infection rates will be assessed following transplantation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: January 16, 2014
• Est. primary completion date: January 16, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled to undergo lung transplantation

• 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.

Exclusion Criteria:

• Severe liver disease

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

• Treatment with posaconazole within 14 days before transplant

• Breastfeeding

Related Conditions & MeSH terms

• Fungal Infection
• Mycoses

Intervention

Drug:
• Posaconazole

• Calogen®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Reach 90% of the Steady State Serum Concentration of Posaconazole	Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The time to reach 90% of the steady state serum posaconazole concentration was to be estimated from fitting a linear model to the concentration data over time. The data did not permit estimation of the endpoint from the modeling proposed in the protocol.	Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43
Primary	Concentration of Posaconazole in Bronchoalveolar Lavage (BAL) and Serum	Concurrent BAL and serum samples for measurement of posaconazole concentration were to be collected during any clinically-indicated bronchoscopy. A participant could have more than 1 bronchoscopy.	Up to Day 42
Secondary	Percentage of Participants Who Develop Invasive Fungal Infection	Invasive fungal infection was assessed using the Mycoses Study Group/European Organisation for Research and Treatment of Cancer (MSG/EORTC) criteria. Infections counted in the analysis were those classified as 'proven', 'probable', or 'possible' according to the criteria.	Up to Day 84