Bacterial Infections
Conditions
Brief summary
The purpose of this study is to evaluate the pharmacokinetics of a single dose of intravenous or oral omadacycline in children and adolescents with suspected or confirmed bacterial infections.
Interventions
Single dose of 100 mg omadacycline IV in 100 mL of normal saline
Single dose of 300 mg omadacycline PO (2 x 150 mg tablets)
Sponsors
Paratek Pharmaceuticals Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects, age 8 to \< 18 (inclusive) who have written and signed parental/legal authorized representative (LAR) informed consent and pediatric assent. * Currently hospitalized with a suspected or confirmed bacterial infection and receiving or planned to receive systemic antibiotic therapy other than omadacycline. * Weight within the 5th and 95th percentile for age and sex. * Subjects must not be pregnant or nursing at the time of enrollment, and must agree to use a highly effective birth control method during the study
Exclusion criteria
* Evidence of a medical condition that may pose a safety risk or impair study participation. * Confirmed or suspected SARS-CoV-2 infection. * Has a history of hypersensitivity or allergic reaction to any tetracycline antibiotic. * Has received an investigational drug within the past 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Volume of Distribution During the Terminal Phase (Vz) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Blood samples were collected and analyzed to determine Vz. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Systemic Clearance (CL) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Blood samples were collected and analyzed to determine CL. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 48hours (AUC0-48) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Blood samples were collected and analyzed to determine the AUC(0-48). Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| AUC(0-48) of Omadacycline After Oral Administration | Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing | Blood samples were collected and analyzed to determine the AUC0-48. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of Omadacycline After IV Infusion | Pre-dose (At least 15 minutes prior to IV infusion), and 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Blood samples were collected and analyzed to determine the AUClast. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| AUClast of Omadacycline After Oral Administration | Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing | Blood samples were collected and analyzed to determine the AUClast. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Blood samples were collected and analyzed to determine AUC0-inf. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| AUC0-inf of Omadacycline After Oral Administration | Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing | Blood samples were collected and analyzed to determine AUC0-inf. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Maximum Observed Plasma Concentration (Cmax) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Blood samples were collected and analyzed to determine Cmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Cmax of Omadacycline After Oral Administration | Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing | Blood samples were collected and analyzed to determine Cmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Blood samples were collected and analyzed to determine Tmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Tmax of Omadacycline After Oral Administration | Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing | Blood samples were collected and analyzed to determine Tmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Elimination Half-life Associated With the Terminal Slope of the Semilogarithmic Concentration-time Curve (t1/2) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Blood samples were collected and analyzed to determine t1/2 and was calculated by using formula. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| t1/2 of Omadacycline After Oral Administration | Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing | Blood samples were collected and analyzed to determine t1/2. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Changes in Physical Examination | Up to Day 2 | A comprehensive physical examination was conducted, encompassing general appearance, skin, neck, eyes, ears, nose, throat, lungs, heart, abdomen, lymph nodes, extremities, and brief neurological exam. |
| Number of Participants With Change From Baseline in Hematology Parameters | Up to Day 2 | Blood samples were collected for the assessment of complete blood count (CBC) including hemoglobin, hematocrit, leukocytes, platelets, mean cell volume, platelet count, white blood cell counts, and differential to include the absolute counts for neutrophils, lymphocytes, eosinophils, monocytes and basophils. |
| Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs), by Relationship to the Study Drug. | Up to Day 7 | An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was any event that had not been present before exposure to the study drug, or any event that had already been present but worsened in intensity or frequency after exposure. |
| Number of Participants Reporting TEAE by Severity | Up to Day 7 | An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was any event that had not been present before exposure to the study drug, or any event that had already been present but worsened in intensity or frequency after exposure. |
| Number of Participants With Change From Baseline in Serum Chemistry Parameters | Up to Day 2 | Blood samples were collected for the assessment of blood glucose, urea, creatinine, sodium, potassium, chloride, bicarbonate, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP), total bilirubin, total protein, albumin, creatine phosphokinase (CK), calcium, phosphate, cholesterol, urate, amylase, lipase and gamma-glutamyl transpeptidase (GGT). |
| Number of Participants With Change From Baseline in Vital Signs | Up to Day 2 | Vital signs included blood pressure, heart rate, and oral body temperature and were collected at the specified timepoints. Vital signs were measured after participants had remained in a supine position for at least 5 minutes using an automated calibrated device. |
| Number of Participants Reporting TEAE, Serious Adverse Events (SAEs) and AE Leading to Discontinuation of Study Drug | Up to Day 7 | An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was any event that had not been present before exposure to the study drug, or any event that had already been present but worsened in intensity or frequency after exposure. An SAE was any adverse event that resulted in death, required hospitalization, persistent or significant disability, congenital anomaly. |
Countries
United States
Contacts
STUDY_DIRECTORAmy Manley
Paratek Pharmaceuticals Inc
Participant flow
Recruitment details
This was an open-label, multi-center study in children and adolescent participants with suspected or confirmed bacterial infections who had received concomitant systemic antibacterial therapy. The study consisted of 2 age cohorts: Cohort 1 (adolescents): 12 to \< 18 years of age and Cohort 2 (children): 8 to \< 12 years of age
Pre-assignment details
A total of 23 participants were enrolled in the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 12.7 years STANDARD_DEVIATION 2.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 7 | 0 / 6 | 0 / 4 |
| other Total, other adverse events | 3 / 6 | 4 / 7 | 4 / 6 | 3 / 4 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 | 0 / 6 | 0 / 4 |
Outcome results
None listed