Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Antibiotic · 1 trial · 1 indication
Pharmacometric analysis of area under the curve at steady state for cohort 1 participants who were dosed with rifampin 10mg/kg Q 24 hours x 4 doses (GA \< 32 weeks, PNA \< 14 days)
Pharmacometric analysis of maximum concentration after first dose for cohort 1 participants who were dosed with rifampin 10 mg/kg Q 24 hours x 4 doses (GA \< 32 weeks, PNA \< 14 days)
Pharmacometric analysis of the clearance for cohort 1 participants who were dosed with rifampin 10 mg/kg Q 24 hours x 4 doses (GA \< 32 weeks, PNA \< 14 days)
Pharmacometric analysis of volume of distribution at steady state for cohort 1 participants who were dosed with rifampin 10 mg/kg Q 24 hours x 4 doses (GA \< 32 weeks, PNA \< 14 days)
| Arm | Type | Description |
|---|---|---|
| Ticarcillin-clavulanate antibiotic | EXPERIMENTAL | Cohort Gestational Age (GA) Postnatal Age (PNA) Dose 1. \<30 weeks \<14 days: 75 mg/kg Q12 hrs x 6 doses 2. \<30 weeks ≥14 days-45 days 75 mg/kg Q 8 hours x 6 doses 3. \<30 weeks \>45 days-90 days 75 mg/kg Q 6 hours x 6 doses Brand name is Timentin. This drug is an antibiotic used to treat a wide variety of bacterial infections. It is a combination of two drugs \& both treat bacterial infections. Ticarcillin is a penicillin-type antibiotic that stops bacterial growth \& clavulanate potassium is an enzyme inhibitor that helps the ticarcillin work better. |
| Rifampin generic antibiotic | EXPERIMENTAL | Cohort GA PNA Dose 1. \<32 weeks \<14 days 10 mg/kg Q 24 hours x 4 doses 2. \<32 weeks ≥14 days-120 days 15 mg/kg Q 24 hours x 4 doses 3. ≥32 weeks \<14 days 15 mg/kg Q 24 hours x 4 doses 4. ≥32 weeks ≥14 days-120 days 20 mg/kg Q 24 hours x 4 doses The brand name is Rifadin, Rimatane. This drug is an antibiotic and a first line antituberculotic and unlabeled use for infections caused by staphylococcus aureus \& staphylococcus epidermis. |
| Clindamycin Generic Antibiotic | EXPERIMENTAL | Cohort GA PNA Dose 1. \<30 weeks \<14 days 10 mg/kg Q 12 hours x 6 doses 2. \<30 weeks ≥14 days-45 days 10 mg/kg Q 8 hours x 6 doses 3. \<30 weeks \>45 days-120 days 10 mg/kg Q 6 hours x 6 doses The brand name is Cleocin. This drug is an antibiotic used to treat a wide variety of bacterial infections and serious infections. |
| Name | Type | Description |
|---|---|---|
| Antibiotic | DRUG | Ticarcillin-clavulanate/Timentin is an antibiotic used to treat a wide variety of bacterial infections. Rifampin/Rifadin/Rimatane is an antibiotic and first line antituberculotic. Clindamycin/Cleocin is an antibiotic used to treat a wide variety of bacterial infections and serious bacterial infections. |
Inclusion Criteria: * Sufficient intravascular access * Suspected systemic infection or receiving 1 of the study drugs per standard of care * informed consent from legal guardian Exclusion Criteria: * history of allergic reaction to study drugs * urine output \<0.5 mL/hr/kg over the prior 24 hour...
Antibiotic is an investigational small molecule being studied for the treatment of systemic infections. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy.
Antibiotic is being developed by Smith & Nephew SNATS, Inc., a company listed on the stock exchange under the ticker symbol SNN. The company is conducting clinical research to evaluate the drug's potential in treating systemic infections.
Antibiotic is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies such as the FDA. The drug is being studied for its safety, tolerability, and pharmacokinetics in patients with systemic infections.
Antibiotic has been studied in one clinical trial with the identifier NCT01728363, titled 'Pharmacokinetics (PK) of Antistaphylococcal Antibiotics in Infants (NICHD-2012-02-Staph Trio)'. This Phase 1 trial was completed and enrolled 63 participants in the United States, focusing on systemic infections.
Antibiotic is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The drug is being studied for the treatment of systemic infections, but it has not yet completed the clinical development process required for regulatory approval.