Trial · NCT05217537
Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections
NCT05217537, Phase 1, Completed, Paratek Pharmaceuticals Inc; results first posted 2026-03-09
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections. Trials, record NCT05217537. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05217537
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections
- NCT number
- NCT05217537
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 23 participants, actual
- Lead sponsor
- Paratek Pharmaceuticals Inc
- Conditions
- Bacterial Infections
- Interventions
- Omadacycline Injection [Nuzyra], Omadacycline Oral Tablet
- First posted
- 2022-02-01
- Last updated
- 2026-03-09
- Results first posted
- 2026-03-09
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Pharmacokinetic Evaluable Population include all participants who received study drug and have at least one evaluable pharmacokinetic parameter. | hours*nanograms per milliliter (h*ng/ml) | GEOMETRIC_MEAN |
| PRIMARY | 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 | Pharmacokinetic Evaluable Population. Only those participants with data available at specified time points have been presented. | h*ng/ml | GEOMETRIC_MEAN |
| PRIMARY | 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 | Pharmacokinetic Evaluable Population | h*ng/ml | GEOMETRIC_MEAN |
| PRIMARY | 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 | Pharmacokinetic Evaluable Population | h*ng/ml | GEOMETRIC_MEAN |
| PRIMARY | 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 | Pharmacokinetic Evaluable Population | h*ng/ml | GEOMETRIC_MEAN |
| PRIMARY | 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 | Pharmacokinetic Evaluable Population. Only those participants with data available at specified time points have been presented. | h*ng/ml | GEOMETRIC_MEAN |
| PRIMARY | 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 | Pharmacokinetic Evaluable Population | nanograms/milliliter (ng/ml) | GEOMETRIC_MEAN |
| PRIMARY | 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 | Pharmacokinetic Evaluable Population | ng/ml | GEOMETRIC_MEAN |
| PRIMARY | 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 | Pharmacokinetic Evaluable Population | hours | MEDIAN |
| PRIMARY | 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 | Pharmacokinetic Evaluable Population | hours | MEDIAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group208
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 48hours (AUC0-48) of Omadacycline After IV Infusion | Adolescents, Cohort 1: 100 mg IV Omadacycline | 8990 | Geometric Coefficient of Variation 27.3 | hours*nanograms per milliliter (h*ng/ml) | |
| Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 48hours (AUC0-48) of Omadacycline After IV Infusion | Children, Cohort 2: 100 mg IV Omadacycline | 13300 | Geometric Coefficient of Variation 40.1 | hours*nanograms per milliliter (h*ng/ml) | |
| AUC(0-48) of Omadacycline After Oral Administration | Adolescents, Cohort 1: 300 mg Oral Omadacycline | 6860 | Geometric Coefficient of Variation 81.5 | h*ng/ml | |
| AUC(0-48) of Omadacycline After Oral Administration | Children, Cohort 2: 300 mg Oral Omadacycline | 17900 | Geometric Coefficient of Variation NA | h*ng/ml | |
| AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of Omadacycline After IV Infusion | Adolescents, Cohort 1: 100 mg IV Omadacycline | 9010 | Geometric Coefficient of Variation 27.4 | h*ng/ml | |
| AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of Omadacycline After IV Infusion | Children, Cohort 2: 100 mg IV Omadacycline | 13300 | Geometric Coefficient of Variation 40.2 | h*ng/ml | |
| AUClast of Omadacycline After Oral Administration | Adolescents, Cohort 1: 300 mg Oral Omadacycline | 6550 | Geometric Coefficient of Variation 91.6 | h*ng/ml | |
| AUClast of Omadacycline After Oral Administration | Children, Cohort 2: 300 mg Oral Omadacycline | 9860 | Geometric Coefficient of Variation 84.9 | h*ng/ml | |
| AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of Omadacycline After IV Infusion | Adolescents, Cohort 1: 100 mg IV Omadacycline | 9720 | Geometric Coefficient of Variation 28.1 | h*ng/ml | |
| AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of Omadacycline After IV Infusion | Children, Cohort 2: 100 mg IV Omadacycline | 14100 | Geometric Coefficient of Variation 38.5 | h*ng/ml |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adolescents, Cohort 1: 100 mg IV Omadacycline | 6 | |
| Overall Study | STARTED | Adolescents, Cohort 1: 300 mg Oral Omadacycline | 7 | |
| Overall Study | STARTED | Children, Cohort 2: 100 mg IV Omadacycline | 6 | |
| Overall Study | STARTED | Children, Cohort 2: 300 mg Oral Omadacycline | 4 | |
| Overall Study | COMPLETED | Adolescents, Cohort 1: 100 mg IV Omadacycline | 6 | |
| Overall Study | COMPLETED | Adolescents, Cohort 1: 300 mg Oral Omadacycline | 7 | |
| Overall Study | COMPLETED | Children, Cohort 2: 100 mg IV Omadacycline | 6 | |
| Overall Study | COMPLETED | Children, Cohort 2: 300 mg Oral Omadacycline | 4 | |
| Overall Study | NOT COMPLETED | Adolescents, Cohort 1: 100 mg IV Omadacycline | 0 | |
| Overall Study | NOT COMPLETED | Adolescents, Cohort 1: 300 mg Oral Omadacycline | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events92
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Adolescents, Cohort 1: 100 mg IV Omadacycline | 1 | 6 | 1 |
| other | Constipation | Gastrointestinal disorders | Adolescents, Cohort 1: 300 mg Oral Omadacycline | 0 | 7 | 0 |
| other | Constipation | Gastrointestinal disorders | Cohort 2 Children 100 mg IV Omadacycline | 1 | 6 | 1 |
| other | Constipation | Gastrointestinal disorders | Cohort 2 Children 300 mg Oral Omadacycline | 0 | 4 | 0 |
| other | Nausea | Gastrointestinal disorders | Adolescents, Cohort 1: 100 mg IV Omadacycline | 0 | 6 | 0 |
| other | Nausea | Gastrointestinal disorders | Adolescents, Cohort 1: 300 mg Oral Omadacycline | 1 | 7 | 1 |
| other | Nausea | Gastrointestinal disorders | Cohort 2 Children 100 mg IV Omadacycline | 1 | 6 | 1 |
| other | Nausea | Gastrointestinal disorders | Cohort 2 Children 300 mg Oral Omadacycline | 1 | 4 | 1 |
| other | Vomiting | Gastrointestinal disorders | Adolescents, Cohort 1: 100 mg IV Omadacycline | 0 | 6 | 0 |
| other | Vomiting | Gastrointestinal disorders | Adolescents, Cohort 1: 300 mg Oral Omadacycline | 1 | 7 | 1 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adolescents, Cohort 1: 100 mg IV Omadacycline | 0 | 6 |
| Total, all-cause mortality | Adolescents, Cohort 1: 300 mg Oral Omadacycline | 0 | 7 |
| Total, all-cause mortality | Cohort 2 Children 100 mg IV Omadacycline | 0 | 6 |
| Total, all-cause mortality | Cohort 2 Children 300 mg Oral Omadacycline | 0 | 4 |
| Total, other adverse events | Adolescents, Cohort 1: 100 mg IV Omadacycline | 3 | 6 |
| Total, other adverse events | Adolescents, Cohort 1: 300 mg Oral Omadacycline | 4 | 7 |
| Total, other adverse events | Cohort 2 Children 100 mg IV Omadacycline | 4 | 6 |
| Total, other adverse events | Cohort 2 Children 300 mg Oral Omadacycline | 3 | 4 |
| Total, serious adverse events | Adolescents, Cohort 1: 100 mg IV Omadacycline | 0 | 6 |
| Total, serious adverse events | Adolescents, Cohort 1: 300 mg Oral Omadacycline | 0 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05217537
GET https://conductscience.org/api/trials/v1/NCT05217537/registered?page=2