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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
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Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| solithromycin | Experimental | oral dosing (capsules and powder for suspension) by weight once per day intravenous dosing by weight once per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| solithromycin | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) of solithromycin in children and adolescents | 5 to 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Cohen-Wolkowiez, MD | Duke Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72202 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31318840 | Derived | Beechinor RJ, Cohen-Wolkowiez M, Jasion T, Hornik CP, Lang JE, Hernandez R, Gonzalez D. A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication. Ther Drug Monit. 2019 Dec;41(6):761-765. doi: 10.1097/FTD.0000000000000670. | |
| 29891609 | Derived | Gonzalez D, James LP, Al-Uzri A, Bosheva M, Adler-Shohet FC, Mendley SR, Bradley JS, Espinosa C, Tsonkova E, Moffett K, Marquez L, Simonsen KA, Stoilov S, Boakye-Agyeman F, Jasion T, Hornik CP, Hernandez R, Benjamin DK Jr, Cohen-Wolkowiez M. Population Pharmacokinetics and Safety of Solithromycin following Intravenous and Oral Administration in Infants, Children, and Adolescents. Antimicrob Agents Chemother. 2018 Jul 27;62(8):e00692-18. doi: 10.1128/AAC.00692-18. Print 2018 Aug. |
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| Orange |
| California |
| 92868 |
| United States |
| Palo Alto | California | 94305 | United States |
| San Diego | California | 92123 | United States |
| Jacksonville | Florida | 32209 | United States |
| Tampa | Florida | 33606 | United States |
| Chicago | Illinois | 60611 | United States |
| Iowa City | Iowa | 52242 | United States |
| Wichita | Kansas | 67214 | United States |
| Louisville | Kentucky | 40202 | United States |
| Shreveport | Louisiana | 71103 | United States |
| Baltimore | Maryland | 21201 | United States |
| St Louis | Missouri | 63110 | United States |
| Omaha | Nebraska | 68198 | United States |
| Hackensack | New Jersey | 07601 | United States |
| Albuquerque | New Mexico | 87131 | United States |
| Albany | New York | 12208 | United States |
| Brooklyn | New York | 11203 | United States |
| Chapel Hill | North Carolina | 27599 | United States |
| Cleveland | Ohio | 44103 | United States |
| Toledo | Ohio | 43606 | United States |
| Portland | Oregon | 97239 | United States |
| Memphis | Tennessee | 38105-3678 | United States |
| Nashville | Tennessee | 37232 | United States |
| Austin | Texas | 78723 | United States |
| Houston | Texas | 77030 | United States |
| Splendora | Texas | 77372 | United States |
| Richmond | Virginia | 23298 | United States |
| Seattle | Washington | 98105 | United States |
| Morgantown | West Virginia | 26506 | United States |
| Milwaukee | Wisconsin | 53226 | United States |
| Plovdiv | 4002 | Bulgaria |
| Rousse | 7002 | Bulgaria |
| Sofia | 1606 | Bulgaria |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C547755 | solithromycin |
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