E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment or prophylaxis against Gram-positive infections |
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E.1.1.1 | Medical condition in easily understood language |
Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052891 |
E.1.2 | Term | Skin bacterial infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Part A 1. To describe the single-dose pharmacokinetics (PK) of IV tedizolid phosphate and its active metabolite, tedizolid, when administered to pediatric subjects, aged 28 days to <24 months (Group 1 [Cohorts 1 and 2 combined]), full-term neonates aged birth to <28 days (Group 2), and preterm neonates aged birth to <28 days (Group 3). 2. To describe the multiple-dose PK of IV tedizolid phosphate and its active metabolite, tedizolid, when administered to full-term neonates aged birth to <28 days (Group 2), and preterm neonates aged birth to <28 days (Group 3). Part B 3. To describe the single-dose PK of tedizolid following oral suspension of tedizolid phosphate administration to pediatric subjects aged 28 days to <24 months (Group 4), full-term neonates aged birth to <28 days (Group 5), and preterm neonates aged birth to <28 days (Group 6).
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E.2.2 | Secondary objectives of the trial |
Part A 1. To evaluate the safety and tolerability of IV tedizolid phosphate administration in pediatric subjects aged 28 days to <24 months (Group 1 [Cohorts 1 and 2 combined]), full-term neonates aged birth to <28 days (Group 2), and preterm neonates aged birth to <28 days (Group 3). Part B 2. To evaluate the safety and tolerability of oral suspension tedizolid phosphate administration in pediatric subjects aged 28 days to <24 months (Group 4), full-term neonates aged birth to <28 days (Group 5), and preterm neonates aged birth to <28 days (Group 6).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Be a male or female aged birth to <24 months 2. Be hospitalized and receiving prophylaxis for or have a confirmed or suspected infection with gram-positive bacteria and receiving concurrent antibiotic treatment with gram-positive antibacterial activity. The most recent dose of concurrent antibiotic treatment should be administered within 24 hours prior to randomization, except for concurrent long-acting antibiotics that are administered once (eg, dalbavancin, oritavancin). 3. Be at least 1 kg in weight. 4. Be in stable condition as determined from medical history, physical examination, electrocardiogram (ECG [minimally 5-lead]; ECG not required for neonates), vital signs, and clinical laboratory evaluations. 5. Have no cardiac or electrocardiogram (ECG) finding which in the opinion of the investigator would limit the subject’s ability to complete and/or participate in this clinical study. For neonates, an ECG is not required, but ECG data will be collected if available. 6. Have serum creatinine within 1.5 × upper limit of the reference range based on age. 7. Have parents willing to adhere to the prohibitions and restrictions specified in this protocol. 8. Have sufficient vascular access to receive trial drug (for subjects enrolled in Part A) and allow for blood draws required by the protocol. 9. Have consent: Parents or subjects’ legally acceptable representative(s) provide documented informed consent indicating that they understand the purpose of and procedures required for the study and are willing to have their child participate in the study. 10. Be able to receive medication by mouth, for subjects to be dosed with oral suspension; dose administration via feeding tube is acceptable. |
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E.4 | Principal exclusion criteria |
1. Has a history of seizures, other than febrile seizures, clinically significant cardiac arrhythmia or condition, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results, as determined by the investigator. 2. Has any acute or chronic condition that, in the opinion of the investigator, would limit the subject’s ability to complete and/or participate in this clinical study. 3. Has used rifampin within 14 days prior to dosing. 4. Has used or will be using proton pump inhibitors, H2 blockers, or antacids (for subjects in Part B, ie, oral suspension dose) at any time from 24 hours prior to dosing through 24 hours after dosing. 5. Recent (3-month) history or current infection with viral hepatitis or other significant hepatic disease. 6. Has a history of drug allergy or hypersensitivity to oxazolidinones. 7. Has had significant blood loss (≥5% of total blood volume) for Groups 2, 3, 5, and 6 and significant blood loss within 4 weeks for Groups 1 and 4 before the Screening Visit. Total blood volume can be estimated as 80 mL per kg of body weight. 8. Need for oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during administration of oral study drug. (Administration during the follow-up period is allowed, as is administration during treatment with IV study drug.) 9. Use of MAOIs or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), and serotonin 5-hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within 14 days prior to study, or planned use while on study. 10. Has received another investigational product within the 30 days prior to enrollment. 11. Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
The pharmacokinetic variables for tedizolid phosphate and tedizolid (AUC 0-last, AUC 0-inf, Cmax, Tmax, apparent terminal t½,) are of interest. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Safety endpoints will include all types of adverse experiences, in addition to laboratory safety tests, and vital signs. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At scheduled Visits until follow up phone contact. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Pharmacokinetic and Safety Study |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Colombia |
Ukraine |
United States |
Bulgaria |
Norway |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |