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| Name | Class |
|---|---|
| Thrasher Research Fund | OTHER |
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This study will determine the concentrations of the antibiotic meropenem when administered as a 3 hour prolonged infusion in children with cystic fibrosis who are hospitalized with an acute pulmonary exacerbation. Safety and practicality of administering meropenem as a 3 hour infusion will be measured.
This study will be conducted at 7 pediatric hospitals in the United States (Columbia University Medical Center, New York, New York; University of North Carolina, Chapel Hill, North Carolina; St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, Connecticut Children's Medical Center, Hartford, Connecticut, Riley Hospital for Children, Indianapolis, Indiana, Nationwide Hospital for Children, Columbus, Ohio, and Children's Medical Center, Dallas, Texas). Cystic Fibrosis children (age 6-17 years) admitted to one of these enrolling sites with an acute exacerbation of his or her pulmonary infection who require antibiotic therapy with meropenem will be eligible. Meropenem will be administered as a 3 hour prolonged infusion and blood concentrations will be measured to determine the population pharmacokinetics in 30 patients, the safety of prolonged infusion meropenem, and the practicality as measured be treatment burden using a questionaire. The population pharmacokinetic model developed will be utilized to determine the optimal dose of meropenem to administer to children with Cystic Fibrosis, and define an exposure response relationship for the drug in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meropenem 3 hour prolonged infusion | Experimental | All 30 participants will receive meropenem as a 3 hour infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| meropenem | Drug | meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Population Pharmacokinetics - Total Body Clearance | Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's total body clearance. | 8 hour dosing interval after 3rd meropenem dose |
| Population Pharmacokinetics - Volume of Central Compartment | Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's volume of the central compartment. | During 8 hour dosing interval after 3rd meropenem dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph L Kuti, Pharm.D. | Hartford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States | ||
| Riley Hospital for Children |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26416780 | Derived | Pettit RS, Neu N, Cies JJ, Lapin C, Muhlebach MS, Novak KJ, Nguyen ST, Saiman L, Nicolau DP, Kuti JL. Population pharmacokinetics of meropenem administered as a prolonged infusion in children with cystic fibrosis. J Antimicrob Chemother. 2016 Jan;71(1):189-95. doi: 10.1093/jac/dkv289. Epub 2015 Sep 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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|
| 14-21 days |
| Practicality of 3 Hour Prolonged Infusion | 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. | 14-21 days |
| Meropenem Pharmacodynamics | 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). | 14-21 days |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Columbia University Medical Center Children's Hospital | New York | New York | 10032 | United States |
| University of North Carolina, North Carolina Children's Hospital | Chapel Hill | North Carolina | 27514 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | United States |
| Children's Medical Center | Dallas | Texas | 75235 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Enrolled participants receiving at least 3 doses of meropenem as a 3 hour prolonged infusion.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Baseline Forced Expiratory Volume in 1st Second (FEV1) (% predicted) | Mean | Standard Deviation | % predicted |
| |||||||||||||||||
| Historical Best FEV1 (% predicted) | The Historical Best FEV1 baseline measure estimates the baseline decline in pulmonary function of the population when not having an acute exacerbation. This value should be greater than the Baseline FEV1 thereby supporting that patients were having an acute pulmonary exacerbation at the start of the study. | Mean | Standard Deviation | % predicted |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Population Pharmacokinetics - Total Body Clearance | Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's total body clearance. | Posted | Mean | Standard Deviation | L/hr/kg | 8 hour dosing interval after 3rd meropenem dose |
|
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| ||||||||||||||||||||||||||
| Primary | Population Pharmacokinetics - Volume of Central Compartment | Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's volume of the central compartment. | Posted | Mean | Standard Deviation | L/kg | During 8 hour dosing interval after 3rd meropenem dose |
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| Secondary | Safety | 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. | Not Posted | 14-21 days | Participants | |||||||||||||||||||||||||||||||
| Secondary | Practicality of 3 Hour Prolonged Infusion | 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. | Not Posted | 14-21 days | Participants | |||||||||||||||||||||||||||||||
| Secondary | Meropenem Pharmacodynamics | 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). | Not Posted | 14-21 days | Participants |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 30 | 7 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | Systematic Assessment | White Blood Cell count decreased from normal to 2.8 thousand cells/microliter; Absolute Neutrophil Count=1960; Hematocrit reduced to 30.2%; Platelets decreased to 39 thousand cells/microliter. This adverse event led to prolongation of hospital stay. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocythemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| C-Reactive Protein Elevation | Immune system disorders | Systematic Assessment |
| ||
| Clostridium difficile Infection | Infections and infestations | Systematic Assessment |
| ||
| Liver Function Test Abnormality | Hepatobiliary disorders | Systematic Assessment | Elevation in aspartate aminotransferase and alanine aminotransferase |
| |
| Hyperbilirubinemia | Hepatobiliary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph L. Kuti, Pharm.D. | Hartford Hospital | 860-972-3612 | joseph.kuti@hhchealth.org |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D011014 | Pneumonia |
| D011552 | Pseudomonas Infections |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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