Trial Outcomes & Findings for Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children (NCT NCT01429259)

Last Updated: 2018-03-20

Results Overview

Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's total body clearance.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

8 hour dosing interval after 3rd meropenem dose

Results posted on

2018-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	Meropenem 3 Hour Prolonged Infusion All 30 participants will receive meropenem as a 3 hour infusion. meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Meropenem 3 Hour Prolonged Infusion n=30 Participants All 30 participants will receive meropenem as a 3 hour infusion. meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion.
Age, Continuous	12.7 years STANDARD_DEVIATION 2.9 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
Baseline Forced Expiratory Volume in 1st Second (FEV1) (% predicted)	58 % predicted STANDARD_DEVIATION 24 • n=5 Participants
Historical Best FEV1 (% predicted)	71 % predicted STANDARD_DEVIATION 25 • n=5 Participants

PRIMARY outcome

Timeframe: 8 hour dosing interval after 3rd meropenem dose

Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's total body clearance.

Outcome measures

Outcome measures
Measure	Meropenem 3 Hour Prolonged Infusion n=30 Participants All 30 participants will receive meropenem as a 3 hour infusion. meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion.
Population Pharmacokinetics - Total Body Clearance	0.36 L/hr/kg Standard Deviation 0.14

PRIMARY outcome

Timeframe: During 8 hour dosing interval after 3rd meropenem dose

Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's volume of the central compartment.

Outcome measures

Outcome measures
Measure	Meropenem 3 Hour Prolonged Infusion n=30 Participants All 30 participants will receive meropenem as a 3 hour infusion. meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion.
Population Pharmacokinetics - Volume of Central Compartment	0.21 L/kg Standard Deviation 0.15

SECONDARY outcome

Timeframe: 14-21 days

This will be an intention to treat analysis of all 30 participants receiving meropenem as a 3 hour prolonged infusion. Participants will be monitored for any sign of symptom of adverse events throughout the course of the study. An adverse event will be defined as any pathologic or unintended change in the structure (signs), function (symptoms), or chemistry (laboratory values) of the body associated with the use of the study drug.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14-21 days

This will be an intention to treat analysis of all 30 participants receiving meropenem as a 3 hour prolonged infusion. The Cystic Fibrosis Questionnaire-Revised (CFQ-R) will be utilized to assess patient or parent assessments of the burden of the prolonged infusion treatment. The CFQ-R will be administered at the beginning of the study and then within 7 days after completion of meropenem therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14-21 days

Meropenem exposures defined from the population model for each participant will be analyzed as a function of the isolated pathogens meropenem minimum inhibitory concentration (MIC) to define the exposure of meropenem associated with an absolute and relative percent change in the Forced Expiratory Volume (FEV1).

Outcome measures

Outcome data not reported

Adverse Events

Meropenem 3 Hour Prolonged Infusion

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Meropenem 3 Hour Prolonged Infusion n=30 participants at risk All 30 participants will receive meropenem as a 3 hour infusion. meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion.
Blood and lymphatic system disorders Pancytopenia	3.3% 1/30 • Number of events 1 • Adverse Events collected from time of consent until completion of the study, which was 7-14 days after completion of meropenem prolonged infusion. Laboratory (chemistry, complete blood count, liver function tests, urinalysis) systematically collected at baseline and end of therapy. Other adverse events documented when reported by the participant or on findings during physical examination.

Other adverse events

Other adverse events
Measure	Meropenem 3 Hour Prolonged Infusion n=30 participants at risk All 30 participants will receive meropenem as a 3 hour infusion. meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion.
Blood and lymphatic system disorders Leukocytosis	3.3% 1/30 • Adverse Events collected from time of consent until completion of the study, which was 7-14 days after completion of meropenem prolonged infusion. Laboratory (chemistry, complete blood count, liver function tests, urinalysis) systematically collected at baseline and end of therapy. Other adverse events documented when reported by the participant or on findings during physical examination.
Blood and lymphatic system disorders Thrombocythemia	3.3% 1/30 • Adverse Events collected from time of consent until completion of the study, which was 7-14 days after completion of meropenem prolonged infusion. Laboratory (chemistry, complete blood count, liver function tests, urinalysis) systematically collected at baseline and end of therapy. Other adverse events documented when reported by the participant or on findings during physical examination.
Skin and subcutaneous tissue disorders Rash	6.7% 2/30 • Adverse Events collected from time of consent until completion of the study, which was 7-14 days after completion of meropenem prolonged infusion. Laboratory (chemistry, complete blood count, liver function tests, urinalysis) systematically collected at baseline and end of therapy. Other adverse events documented when reported by the participant or on findings during physical examination.
General disorders Fever	6.7% 2/30 • Adverse Events collected from time of consent until completion of the study, which was 7-14 days after completion of meropenem prolonged infusion. Laboratory (chemistry, complete blood count, liver function tests, urinalysis) systematically collected at baseline and end of therapy. Other adverse events documented when reported by the participant or on findings during physical examination.
Immune system disorders C-Reactive Protein Elevation	10.0% 3/30 • Adverse Events collected from time of consent until completion of the study, which was 7-14 days after completion of meropenem prolonged infusion. Laboratory (chemistry, complete blood count, liver function tests, urinalysis) systematically collected at baseline and end of therapy. Other adverse events documented when reported by the participant or on findings during physical examination.
Infections and infestations Clostridium difficile Infection	6.7% 2/30 • Adverse Events collected from time of consent until completion of the study, which was 7-14 days after completion of meropenem prolonged infusion. Laboratory (chemistry, complete blood count, liver function tests, urinalysis) systematically collected at baseline and end of therapy. Other adverse events documented when reported by the participant or on findings during physical examination.
Hepatobiliary disorders Liver Function Test Abnormality	6.7% 2/30 • Adverse Events collected from time of consent until completion of the study, which was 7-14 days after completion of meropenem prolonged infusion. Laboratory (chemistry, complete blood count, liver function tests, urinalysis) systematically collected at baseline and end of therapy. Other adverse events documented when reported by the participant or on findings during physical examination.
Hepatobiliary disorders Hyperbilirubinemia	3.3% 1/30 • Adverse Events collected from time of consent until completion of the study, which was 7-14 days after completion of meropenem prolonged infusion. Laboratory (chemistry, complete blood count, liver function tests, urinalysis) systematically collected at baseline and end of therapy. Other adverse events documented when reported by the participant or on findings during physical examination.

Additional Information

Joseph L. Kuti, Pharm.D.

Hartford Hospital

Phone: 860-972-3612

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place