Trial · NCT06462235
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Predicted Plasma Concentration (Cmax) of ATM and AVI | Up to Day 15 | Cmax is the maximum plasma concentration of ATM and AVI as population pharmacokinetic (popPK) analysis predicts. |
| Primary | Area under the Concentration-Time Curve (AUC) of ATM-AVI | Up to Day 15 | AUC is a measure of the plasma concentration of ATM and AVI overtime as popPK analysis predicts. |
| Primary | Plasma Elimination Half-Life (t1/2) | Up to Day 15 | Half-life is the time measured for the plasma concentration of ATM and AVI to decrease by one half as popPK analysis predicts. |
| Primary | Apparent Clearance (CL) | Up to Day 15 | ATM and AVI clearance is a quantitative measure of the rate at which ATM and AVI are removed from the blood (rate at which ATM and AVI are metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed. |
| Primary | Plasma concentrations of ATM and AVI by nominal sampling time | Up to Day 15 | Plasma concentrations of ATM and AVI on Day 1 and at steady state (Day 2 or later) will be summarized by the nominal sampling time using descriptive statistics (eg number, mean, standard deviation). |
| Primary | Proportion of Participants reporting Adverse Events (AE) | Baseline up to Day 50 | Proportion of participant AE reports of vital signs, physical examinations, and clinical laboratory tests overall and by age cohort. For each AE the last assessment made prior to the first dose of study drug will be defined as the baseline. |
| Primary | Proportion of Participants reporting Serious Adverse Events (SAE) | Baseline up to Day 50 | Proportion of participant SAE reports of vital signs, physical examinations, and clinical laboratory tests overall and by age cohort. For each SAE the last assessment made prior to the first dose of study drug will be defined as the baseline. |
| Primary | Proportion of Participants reporting AEs leading to discontinuation of study drug | Baseline up to Day 50 | Proportion of Participants reporting AEs leading to discontinuation of study drug from baseline. For each discontinuation the last assessment made prior to the first dose of study drug will be defined as the baseline. |
| Primary | Proportion of Participants reporting AEs resulting in death | Baseline up to Day 50 | Proportion of Participants reporting AE resulting in death from baseline. For each death the last assessment made prior to the first dose of study drug will be defined as the baseline. |
| Primary | Proportion of Participants reporting liver injury and acute kidney injury | Baseline up to Day 50 | Proportion of Participants reporting liver injury and acute kidney injury from baseline. For each report of liver and acute kidney injury the last assessment made prior to the first dose of study drug will be defined as the baseline. |
| Secondary | Part B: Proportion of participants with each clinical outcome and with a favorable clinical outcome at end of IV study treatment (EOIV) | Up to 15 days after start of IV study treatment | Clinical Cure is defined baseline signs and symptoms improved such that no further antimicrobial treatment is required for an aerobic gram-negative baseline infection. Participants who receive treatment for gram-positive organisms or adjunctive therapy for Pseudomonas aeruginosa, as allowed per protocol, can still have a response of cure. Clinical improvement is defined as baseline signs and symptoms sufficiently improved to allow switching to an oral antibiotic treatment. A favorable outcome is clinical cure or clinical improvement. Failure is defined as a requirement for further antibiotic treatment, including following premature discontinuation due to an adverse event, or death after receiving at least 48 hours of treatment. Indeterminant is defined as data not available for evaluation of efficacy for any reason. |
| Secondary | Part B: Proportion of participants with each clinical outcome and with a favorable clinical outcome at end of treatment (EOT) | Within 48 hours after last dose of oral switch treatment | EOT is only applicable for participants switched to an oral antibiotic treatment. Possible outcomes are cure, failure, or indeterminant. |
| Secondary | Part B: Proportion of participants with each clinical outcome and with a favorable clinical outcome at test of cure (TOC) | 7-14 days after the last study treatment | Possible outcomes are cure, failure, or indeterminant. |
| Secondary | Part B: Proportion of participants with a favorable microbiological response at TOC | 7-14 days after the last study treatment | A favorable response is eradication or presumed eradication. Eradication is absence of the causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication is when a repeat culture was not performed and the clinical response is cure. |
| Secondary | Part B: Counts and proportions of pathogens with each per-pathogen microbiological response at EOIV/EOT | Up to 15 days after start of IV study treatment | Possible outcomes are eradication, presumed eradication, persistence, presumed persistence or indeterminate. Presumed eradication/persistence based on repeat culture not performed and clinical outcome of cure/failure. Persistence is the causative pathogen is still present from an appropriately obtained specimen at the site of the infection. Indeterminant includes participant lost to follow-up or death after receiving less than 48 hours of study treatment. |
| Secondary | Part B: Counts and proportions of pathogens with each per-pathogen microbiological response at TOC | 7-14 days after the last study treatment | Possible outcomes are eradication, presumed eradication, persistence, presumed persistence or indeterminate. |
| Secondary | Part B: Counts and proportions of participants with emergent infections (new infections or superinfections) during the study | Through study completion, up to Day 50 | Superinfection is defined as emergence of a new pathogen associated with worsening signs and symptoms of infection and a requirement for additional antibiotics during the period up to and including EOIV/EOT. New infection is defined as emergence of a new pathogen associated with worsening signs and symptoms of infection and a requirement for additional antibiotics during the period after EOIV/EOT. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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