Oral Antibiotic Pharmacokinetics in Young Infants
2026年9月8日 更新者：University of Colorado, Denver
Characterizing Absorption Kinetics of Oral Antibiotics in Young Infants to Enhance Precision Dosing
This observational study will characterize the pharmacokinetics of linezolid in young infants.
Participants will receive linezolid either as part of routine clinical care or as a single, one-time study dose.
Blood samples collected following linezolid administration will be used to measure drug concentrations and describe how linezolid is absorbed, distributed, metabolized, and eliminated in this population.
Clinical information, including demographic characteristics, laboratory values, and treatment details, will also be collected.
The results will be used to develop pharmacokinetic models to improve linezolid dosing recommendations and support precision dosing in young infants.
調査の概要
状態
まだ募集していません
介入・治療
詳細な説明
Young infants are at increased risk for serious bacterial infections, yet limited pharmacokinetic data are available to guide evidence-based dosing of oral linezolid in this population. Developmental changes in drug absorption, distribution, metabolism, and elimination during early infancy contribute to variability in drug exposure, making it difficult to optimize dosing using existing recommendations.
This prospective pharmacokinetic study will enroll young infants who receive linezolid either as part of routine clinical care or as a single, one-time study dose. Blood samples will be collected to measure plasma linezolid concentrations, and demographic, clinical, laboratory, and medication data will be collected from the medical record. These data will be used to develop pharmacokinetic models and evaluate sources of variability in linezolid exposure, including developmental and clinical factors.
The results of this study are expected to improve the understanding of oral linezolid pharmacokinetics in young infants and support the development of model-informed dosing strategies to optimize antibiotic exposure, maximize treatment effectiveness, and minimize toxicity in this vulnerable population.
研究の種類
介入
入学 (推定)
40
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Colorado
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Aurora、Colorado、アメリカ、80045
- University of Colorado, Denver
-
コンタクト：
- Andrew S Haynes, MD
- 電話番号：720-777-6783
- メール：andrew.haynes@childrenscolorado.org
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主任研究者：
- Andrew S Haynes, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Hospitalized neonate or young infant ≤90 days postnatal age at screening
- Weight ≥2 kg
- Receiving systemic antibiotic therapy
- Tolerating enteral medication(s) and/or enteral feeds
- Group 1: Receiving oral linezolid as part of routine clinical care.
- Group 2: Receiving systemic antibiotic therapy but not prescribed linezolid clinically and eligible to receive a single oral study dose.
Exclusion Criteria:
- Known hypersensitivity or allergy to linezolid
- Renal dysfunction (defined by age-appropriate serum creatinine and/or urine output)
- Hepatic dysfunction (AST or ALT ≥3x age-specific upper limit of normal or clinically significant hepatic failure)
- Gastrointestinal disorders expected to significantly impair drug absorption (e.g., short bowel syndrome, severe malabsorption)
- Severe anemia or other condition that precludes study-required blood sampling
- Extracorporeal support or other devices expected to substantially alter drug pharmacokinetics (e.g., extracorporeal membrane oxygenation [ECMO]).
- Therapeutic hypothermia
- Ongoing clinical instability that, in the opinion of the treating team or principal investigator (PI), would make study participation unsafe (e.g., escalating vasoactive support or rapidly worsening organ dysfunction).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Group 1: Routine Clinical Linezolid
Participants receiving linezolid as part of routine clinical care will undergo pharmacokinetic blood sampling and clinical data collection.
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実験的：Group 2: Single Study Dose of Linezolid
Participants will receive a single study-administered dose of linezolid (10 mg/kg/dose enterally) followed by pharmacokinetic blood sampling and clinical data collection.
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Linezolid is administered either as part of routine clinical care or as a single, one-time study dose (10 mg/kg/dose enterally), depending on study arm.
Participants undergo pharmacokinetic blood sampling after linezolid administration to characterize drug disposition in young infants.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Area under the plasma linezolid concentration versus time curve from 0 to 24 hours (AUC0-24)
時間枠：From 0 to 24 hours after administration of an enteral linezolid dose
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Area under the plasma linezolid concentration versus time curve from 0 to 24 hours (AUC0-24) will be estimated using plasma linezolid concentrations collected after enteral administration of linezolid (either routine clinical dosing or a single study dose) and pharmacokinetic modeling.
AUC0-24 will be reported in mcg hour per mL.
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From 0 to 24 hours after administration of an enteral linezolid dose
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Apparent clearance of linezolid (CL/F)
時間枠：From 0 to 12 hours after administration an enteral linezolid dose
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Apparent clearance of linezolid following enteral administration (either routine clinical dosing or a single study dose) will be estimated from plasma linezolid concentrations using population pharmacokinetic modeling.
Apparent clearance will be reported in L/hour.
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From 0 to 12 hours after administration an enteral linezolid dose
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Apparent volume of distribution of linezolid (V/F)
時間枠：From 0 to 12 hours after administration of an enteral linezolid dose
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Apparent volume of distribution of linezolid following enteral administration (either routine clinical dosing or a single study dose) will be estimated from plasma linezolid concentrations using population pharmacokinetic modeling.
Apparent volume of distribution will be reported in L per kilogram of body weight.
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From 0 to 12 hours after administration of an enteral linezolid dose
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Absorption rate constant of linezolid (Ka)
時間枠：From 0 to 12 hours after administration of an enteral linezolid dose
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The absorption rate constant of linezolid following enteral administration (either routine clinical dosing or a single study dose) will be estimated from plasma linezolid concentrations using population pharmacokinetic modeling.
The absorption rate constant will be reported in 1/hour.
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From 0 to 12 hours after administration of an enteral linezolid dose
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Concentrations of Linezolid and Primary Metabolites in Plasma
時間枠：From 0 to 12 hours after administration of an enteral linezolid dose
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Measure plasma concentrations of linezolid and its primary metabolites at prespecified sampling time points following routine clinical dosing or a single study dose.
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From 0 to 12 hours after administration of an enteral linezolid dose
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Percentage of participants achieving the prespecified linezolid pharmacodynamic target
時間枠：From 0 to 12 hours after administration of an enteral linezolid dose
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Pharmacodynamic target attainment will be determined using model-estimated linezolid exposure and a prespecified pharmacodynamic target based on the AUC0-24/MIC ratio.
The specific target threshold will be defined in the study analysis plan based on available pharmacodynamic data.
The outcome will be reported as the percentage of participants achieving the prespecified target.
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From 0 to 12 hours after administration of an enteral linezolid dose
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Percentage of Participants Experiencing One or More Adverse Events or Serious Adverse Events
時間枠：From signing the informed consent form through study completion, up to 5 days
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Adverse events and serious adverse events will be assessed from signing the informed consent form through study completion, up to 5 days.
The incidence, severity, and type of adverse events and serious adverse events will be assessed.
The outcome will be reported as the percentage of participants experiencing one or more adverse events or serious adverse events.
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From signing the informed consent form through study completion, up to 5 days
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Difference between PBPK model predicted and observed linezolid plasma concentrations
時間枠：From 0 to 12 hours after administration of an enteral linezolid dose
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PBPK model predicted plasma linezolid concentrations will be compared with observed plasma linezolid concentrations collected at prespecified sampling time points.
Predictive performance will be summarized using the ratio of predicted to observed concentrations.
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From 0 to 12 hours after administration of an enteral linezolid dose
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2027年1月1日
一次修了 (推定)
2029年12月31日
研究の完了 (推定)
2030年12月31日
試験登録日
最初に提出
2026年8月6日
QC基準を満たした最初の提出物
2026年9月8日
最初の投稿 (実際)
2026年9月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月11日
QC基準を満たした最後の更新が送信されました
2026年9月8日
最終確認日
2026年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。