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HIV 感染および HIV 非感染 MDR-TB の小児における多剤耐性結核 (MDR-TB) のための最適化された多剤バックグラウンドレジメン (OBR) と組み合わせたデラマニドの薬物動態、安全性、および忍容性の評価

2026年5月31日 更新者：National Institute of Allergy and Infectious Diseases (NIAID)

HIV 感染者および HIV 患者における多剤耐性結核 (MDR-TB) に対する最適化された多剤耐性結核 (OBR) と組み合わせたデラマニドの薬物動態、安全性、忍容性を評価する第 I/II 相非盲検単群試験-MDR-TBに感染していない子供

この研究では、抗結核 (TB) 薬デラマニド (DLM) の薬物動態、安全性、および忍容性を、HIV 感染および多剤耐性結核 (MDR-TB) に対する最適化された多剤併用療法 (OBR) と組み合わせて評価します。 HIVに感染していないMDR-TBの子供。

調査の概要

状態

完了

条件

介入・治療

詳細な説明

この研究の目的は、MDR-TB の HIV 感染児および HIV 非感染児における MDR-TB に対する抗結核薬 DLM と OBR の組み合わせの薬物動態、安全性、および忍容性を評価することです。

参加者は、12 歳から 18 歳未満、6 歳から 12 歳未満、3 歳から 6 歳未満、または 0 歳から 3 歳未満の 4 つの年齢コホートのいずれかに登録されます。 すべての参加者は、年齢層と体重に応じて 24 週間投与される DLM を受け取ります。

研究訪問は研究登録時に行われます。 2週目と4週目。 40週まで4週間ごと;および 48、60、72、および 96 週目。 訪問には身体検査が含まれる場合があります。血液、尿、および喀痰の採取;胸部X線;心電図 (ECG);聴力検査;順守評価;受容性アンケート。

研究の種類

介入

入学 (実際)

37

段階

  • フェーズ2
  • フェーズ 1

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

  • インド
    • Maharashtra
      • Pune、Maharashtra、インド、411001
        • Byramjee Jeejeebhoy Medical College (BJMC) CRS
  • タンザニア
      • Moshi、タンザニア
        • Kilimanjaro Christian Medical Centre (KCMC)
  • 南アフリカ
    • Gauteng
      • Johannesburg、Gauteng、南アフリカ
        • Sizwe CRS
    • North West
      • Klerksdorp、North West、南アフリカ、2574
        • PHRU Matlosana CRS
    • Western Cape
      • Cape Town、Western Cape、南アフリカ、7505
        • Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS

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

14年歳未満 (子)

健康ボランティアの受け入れ

いいえ

説明

包含基準:

  • -親（または法定後見人）は、子供の研究参加について書面によるインフォームドコンセントを喜んで提供することができます。 さらに、施設の治験審査委員会/倫理委員会 (IRB/EC) のポリシーおよび手順に従って同意が必要な子供については、子供は、研究への参加に対して書面による同意を喜んで提供することができます。
  • 入学時の年齢が18歳未満
  • -HIVに感染していない、またはHIVに感染している（この基準の詳細については、プロトコルを参照してください）
  • -HIV感染の場合：登録の少なくとも2週間前に標準治療の抗レトロウイルス療法（ART）レジメンを開始した（注：エファビレンツ[EFV]、ネビラピン[NVP]、ブーストされたプロテアーゼ阻害剤[PI]、またはインテグラーゼストランドトランスファーを含むレジメン阻害剤 [INSTI] は許可されます)

  • 次のように分類される MDR-TB が確認された、または可能性が高い:

    • 確定多剤耐性結核（またはリファンピシン一剤耐性結核[RMR-TB]、前広範囲薬剤耐性[XDR]またはXDR-TB）：

      • 結核と一致する胸部X線写真に基づく胸腔内（肺）結核、および/または以下のいずれかの形態の胸郭外結核：
      • 1) 末梢結核リンパ節炎
      • 2) 胸水または線維性胸膜病変
      • 3) ステージ1の結核性髄膜炎
      • 4) 粟粒結核および腹部結核
      • 5) その他の非播種性結核病 (以下の除外基準も参照)
      • と
      • 培養法または分子法 (Xpert MTB/RIF を含む) による臨床検体からの結核菌の微生物学的確認
      • と
      • 遺伝子型（分子）または表現型の方法によって示された薬剤耐性であり、以下のいずれかの耐性パターンがある：
      • MDR-TB（リファンピシンとイソニアジドの両方に対する耐性）
      • RMR-TB、または追加のイソニアジド (INH) 耐性が確認されていない場合 (すなわち、分離された Xpert MTB/RIF リファンピシン耐性)
      • Pre-XDR-TB (MDR-TB とフルオロキノロンまたは二次注射剤に対する耐性)
      • XDR-TB (MDR-TB プラスフルオロキノロンと二次注射の両方に対する耐性)
      • 注: したがって、RMR-TB、MDR-TB、pre-XDR-TB、および XDR-TB は、プロトコルの目的でまとめて「MDR-TB」と呼ばれます。

    • MDR-TB（またはRMR、プレXDRまたはXDR-TB）の可能性があり、以下にリストされている胸腔内および/または胸腔外結核を含む：

      • 十分に記録された結核の臨床症状または徴候に基づく胸腔内（肺）結核の推定診断、および結核と一致する胸部レントゲン写真、および/または以下の胸部外結核のいずれかの形態：
      • 末梢結核リンパ節炎
      • 胸水または線維性胸膜病変
      • ステージ 1 TB 髄膜炎
      • 粟粒結核および腹部結核、
      • -他の非播種性結核病（以下の除外基準も参照）
      • と
      • 次のいずれかです。
      • MDR-TB感染源と確認された症例*（RMR-TB、XDR-TB前、XDR-TB）への暴露
      • 一次レジメンに反応しなかったことが文書化されており、遵守が十分に文書化されている場合。
      • と
      • MDR-TBの治療が臨床的に決定されました
      • * 胸腔外結核を伴うまたは胸腔外結核を伴わない胸腔内結核の症例として定義される確定 MDR-TB ソース症例、培養または分子的方法 (Xpert MTB/RIF を含む) による臨床検体からの結核菌の微生物学的確認、および薬剤耐性が実証された症例上記の耐性パターンのいずれかを使用して、遺伝子型（分子）または表現型の方法によって。
  • -登録前30日以内に2.8 g / dLを超えるアルブミンレベル
  • カリウムが 3.4 を超え 5.6 mmol/L 未満。 -登録前30日以内に0.59mmol / Lを超えるマグネシウム。 注: 電解質を補充することができ、資格基準を満たすために再チェックを行うことができます。
  • 5歳以上の子供のBMI Zスコアが-3より大きい;長さ/高さの体重 スクリーニング時の5歳未満の子供のZスコアが-3より大きい（最新の世界保健機関のスコアを使用）
  • -スクリーニング時の体重が3kg以上
  • -通常の治療決定に従って、適切な最適化されたバックグラウンドレジメン（OBR）MDR-TB治療レジメンを開始しましたが、登録の少なくとも2週間前から8週間以内であり、サイト調査官の意見では、レジメンによく耐えています登録。 注: 適切な OBR MDR-TB 治療レジメンは、既知の場合は感染分離株の感受性、既知の場合は過去の治療歴に基づいた要素を含むものとして定義されます。 このレジメンは、プロトコルに記載されている OBR MBR-TB 治療ガイドラインにも従う必要があります。
  • 男性で、女性パートナーの妊娠につながる可能性のある性行為に従事している場合: バリア避妊法 (すなわち、 男性用コンドーム) 研究の最初の 28 週間 (すなわち、DLM の中止後 4 週間まで) を通して。
  • 初潮に達し、文書化された滅菌手順（子宮摘出術、両側卵巣摘出術、または卵管摘出術）を受けていないと定義された、女性で生殖能力のある場合：登録前の14日以内のスクリーニングでの妊娠検査が陰性。
  • 女性の場合、生殖能力があり（プロトコルで定義）、妊娠につながる可能性のある性行為に従事している場合: 妊娠を避け、DLM を受けている間および DLM を中止してから 1 か月間、次の形式の避妊のいずれかを使用することに同意します: コンドーム、横隔膜または子宮頸管キャップ、子宮内避妊器具 (IUD)、ホルモンベースの避妊。 選択した方法は、登録前に開始する必要があります。

除外基準:

  • -ニトロイミダゾールまたはニトロイミダゾール誘導体に対する既知のアレルギー
  • -プロトコルに記載されている禁止薬物の積極的な使用、登録後3日以内

  • 参加者は、母体のレポートと利用可能な医療記録に基づいて、サイトの調査員または被指名人によって決定される、次のいずれかの病歴があります。

    • Torsade de Pointesのリスクを高める投薬または心疾患（心不全、冠動脈疾患）の病歴を必要とする重大な心不整脈
    • -スクリーニング時の重大な胃腸（GI）、代謝、神経精神医学、腎臓または内分泌疾患であり、調査員の意見では、治験への安全な参加および/または主要評価項目の評価を妨げる
    • 以前の DLM またはプレトマニド暴露
    • 注: 参加者は、登録前に最大 14 + 3 日間 (つまり、最大 17 日間) の DLM を受け取ることができます。
  • -異常な心電図（ECG）（QTcF [フレデリシア補正を使用して補正されたQT間隔の平均値、3回実行されたECGでの補正] 450ミリ秒以上、房室ブロック、または120ミリ秒以上の延長QRSを含む）
  • -スクリーニング時に、16歳以上の参加者のカルノフスキースコアが30％未満、または16歳未満の参加者のランスキープレイスコアが30％未満
  • -研究調査員の意見では、研究への参加を妨げる可能性がある、および/またはDLMの使用に伴う安全上の懸念を引き起こす可能性のあるアルコール摂取
  • 登録時に母乳育児を計画している授乳中
  • -結核性髄膜炎（TBM）ステージ2または3、またはスクリーニング時の骨関節結核
  • -スクリーニング時に、薬理学的レジメンを含む他の試験に同時登録
  • HIV 感染者で 2 歳未満の場合: 登録時に授乳中

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：処理
  • 割り当て：非ランダム化
  • 介入モデル：単一グループの割り当て
  • 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
実験的：Cohort 1 (>=12 to < 18 years)
Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB.
薬：Delamanid

Administered orally; dosing based on participants' weight.

≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation)

他の名前：
  • DLM
薬：Optimized multidrug background regimen (OBR) for children with MDR-TB
Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks.
実験的：Cohort 2 (>=6 to < 12 years)
Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB.
薬：Delamanid

Administered orally; dosing based on participants' weight.

≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation)

他の名前：
  • DLM
薬：Optimized multidrug background regimen (OBR) for children with MDR-TB
Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks.
実験的：Cohort 3 (>=3 to < 6 years)
Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB.
薬：Delamanid

Administered orally; dosing based on participants' weight.

≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation)

他の名前：
  • DLM
薬：Optimized multidrug background regimen (OBR) for children with MDR-TB
Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks.
実験的：Cohort 4 (>=0 to < 3 years)
Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB.
薬：Delamanid

Administered orally; dosing based on participants' weight.

≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation)

他の名前：
  • DLM
薬：Optimized multidrug background regimen (OBR) for children with MDR-TB
Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks.

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
Percentage of Participants With Adverse Events of ≥ Grade 3 Severity
時間枠：Measured from entry through Week 24
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). 95% CIconfidence interval (CI) computed using exact Clopper-Pearson method.
Measured from entry through Week 24
Percentage of Participants With Adverse Events of ≥ Grade 3 Assessed by the Core Team to be at Least Possibly Related to the Study Drug
時間枠：Measured from entry through Week 24
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). 95% CI computed using exact Clopper-Pearson method.
Measured from entry through Week 24
Percentage of Participants Who Were Terminated From Study Treatment Due to a Drug-related Adverse Event
時間枠：Measured from entry through Week 24
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1. 95% CI computed using exact Clopper-Pearson method.
Measured from entry through Week 24
Percentage of Participants With Absolute Corrected QT Interval by Fridericia (QTcF) ≥ 500 Msec
時間枠：Entry, weeks 2, 8, 12, 16, 20, and 24
Evaluation of the Electrocardiogram (ECG) QTcF was performed per protocol. ECGs conducted at these visits were performed in triplicate (if possible). Consultation with the protocol cardiologist was available and encouraged for any abnormal or equivocal ECG findings and/or questions related to cardiac toxicities and assessment. Participants were counted if they had QTcF ≥ 500 msec at any study visit from entry to Week 24. 95% CI computed using exact Clopper-Pearson method.
Entry, weeks 2, 8, 12, 16, 20, and 24
Percentage of Participants Who Died Through Week 24
時間枠：Measured from entry through Week 24
Death due to all causes included. 95% CI computed using exact Clopper-Pearson method.
Measured from entry through Week 24
Geometric Mean of Area Under the Concentration Versus Time Curve (AUC0-24h) DLM
時間枠：Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose

PK parameter was determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model

The starting population PK model was developed on data from Otsuka study 232 and 233 (1). NONMEM was used when developing the final model for the population in this study.

  • Developed a population PK model as part of the final PK analysis
  • Data used in the population PK analysis included the semi-intensive PK visit (week 0, 2 and 8) and sparse PK visits (week 4, 12, 16, 24 and 28).
Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
Geometric Mean of Area Under the Concentration Versus Time Curve (AUC0-24h) DM-6705
時間枠：Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose

PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model

The starting population PK model was developed on data from Otsuka study 232 and 233 (1). NONMEM was used when developing the final model for the population in this study.

  • Developed a population PK model as part of the final PK analysis
  • Data used in the population PK analysis included the semi-intensive PK visit (week 0, 2 and 8) and sparse PK visits (week 4, 12, 16, 24 and 28).
Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
Geometric Mean of Area of Maximal Concentration (Cmax) DLM
時間枠：Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
Geometric Mean of Area of Maximal Concentration (Cmax) DM-6705
時間枠：Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
Median Time of Maximal Concentration (Tmax) DLM
時間枠：Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
Median Time of Maximal Concentration (Tmax) DM-6705
時間枠：Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
Median Oral Clearance (Cl/F) DLM
時間枠：Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
Median Oral Clearance (Cl/F) DM-6705
時間枠：Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
Median Volume of Distribution (Vd) DLM
時間枠：Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
Median Volume of Distribution (Vd) DM-6705
時間枠：Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
Median Mean Absorption Time (MAT) DLM
時間枠：Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
Median Terminal Half-life (t1/2) DLM
時間枠：Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
Median Terminal Half-life (t1/2) DM-6705
時間枠：Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants With Adverse Events ≥ Grade 3 Severity
時間枠：Measured from entry through Week 72 post DLM
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). A higher grade indicates worse outcome. 95% CI computed using exact Clopper-Pearson method.
Measured from entry through Week 72 post DLM
Percentage of Participants With Adverse Events ≥ Grade 3 Severity Assessed by the Core Team to be at Least Possibly Related to the Study Drug
時間枠：Measured from entry through Week 72 post DLM
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). A higher grade indicates worse outcome. 95% CI computed using exact Clopper-Pearson method.
Measured from entry through Week 72 post DLM
Percentage of Participants With Absolute Corrected QT Interval by Fridericia (QTcF) ≥ 500 Msec
時間枠：Screening, Entry, weeks 2, 8, 12, 16, 20, 24 and week 28
Evaluation of the Electrocardiogram (ECG) QTcF was performed per protocol. ECGs conducted at these visits should be performed in triplicate (if possible). Consultation with the protocol cardiologist was available and encouraged for any abnormal or equivocal ECG findings and/or questions related to cardiac toxicities and assessment. Participants were counted as having an outcome if they had QTcF ≥ 500 msec at any study visit from entry to Week 28. 95% CI computed using exact Clopper-Pearson method.
Screening, Entry, weeks 2, 8, 12, 16, 20, 24 and week 28
Percentage of Participants Who Died Through Week 72 Post DLM
時間枠：Measured from entry through Week 72 post DLM
Death due to all causes included. 95% CI computed using exact Clopper-Pearson method.
Measured from entry through Week 72 post DLM
Percentage of Participants With Adverse Events ≥ Grade 2 Severity
時間枠：Measured from entry through Week 72 post DLM
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). A higher grade indicates worse outcome. 95% CI computed using exact Clopper-Pearson method.
Measured from entry through Week 72 post DLM
Percentage of Participants With Adverse Events ≥ Grade 2 Severity Assessed by the Core Team to be at Least Possibly Related to the Study Drug.
時間枠：Measured from entry through Week 72 post DLM
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). A higher grade indicates worse outcome. 95% CI computed using exact Clopper-Pearson method.
Measured from entry through Week 72 post DLM
Count of Participants With Change in QTcF Interval From Baseline of Greater Than 60 ms
時間枠：Entry, weeks 2, 8, 12, 16, 20, 24, and week 28
Evaluation of the Electrocardiogram (ECG) QTcF was performed per protocol. ECGs conducted at these visits should be performed in triplicate (if possible). Consultation with the protocol cardiologist was available and encouraged for any abnormal or equivocal ECG findings and/or questions related to cardiac toxicities and assessment. Participants were counted if they had QTcF was greater than 60 msec at any study visit from entry to Week 28.
Entry, weeks 2, 8, 12, 16, 20, 24, and week 28
Percentage of Participants (Overall) With TB Treatment Outcomes
時間枠：Measured from entry through Week 72 post DLM
Site investigator assessment of participant TB treatment outcomes through last study visit were entered into the eCRF. Treatment outcomes in children were defined as bacteriologic cure, probable cure, death, treatment failure, TB recurrence, and loss to follow-up as per protocol.
Measured from entry through Week 72 post DLM
Number of Participants Who Had Permanently Discontinued Study Drug Whilst on Study Due to Intolerance or Refusal to Take Medication
時間枠：Measured from entry through Week 24
Participants were assessed for tolerability of the study drug during the study by their intolerance or refusal to take the medications
Measured from entry through Week 24
Frequency of Cumulative Responses to Taste of Study Drug in an Acceptability Assessment
時間枠：Assessments conducted at weeks 2, 8 and 24
Acceptability assessments were assessed by Study Staff at study visits and by Participant Caregiver whilst at home. The participants had the option of taking the study drug either as dispersible tablet or tablet formulation.
Assessments conducted at weeks 2, 8 and 24
Frequency of Cumulative Responses to Formulation of Study Drug in an Acceptability Assessment
時間枠：Assessments conducted at weeks 2, 8 and 24
Acceptability assessments were assessed by Study Staff at study visits and by Participant Caregiver whilst at home. The participants had the option of taking the study drug either as dispersible tablet or tablet formulation. At a visit, the participant could have been taking a dispersible tablet and at the next visit the same participant could have been taking a tablet formulation.
Assessments conducted at weeks 2, 8 and 24
Frequency of Cumulative Responses to Taste of Dispersible Tablet Doses in an Acceptability Assessment
時間枠：Assessments conducted at weeks 2, 8 and 24
Acceptability assessments were assessed by Study Staff at study visits and by Participant Caregiver whilst at home. Participants' dose formulations were not restrictive as at each visit, the participant was given the option of taking the study drug as either a dispersible tablet or tablet formulation. At a visit, the participant could have been taking a dispersible tablet and at the next visit the same participant could have been taking a tablet formulation.
Assessments conducted at weeks 2, 8 and 24
Frequency of Cumulative Responses to Administration of Dispersible Tablet Doses in an Acceptability Assessment
時間枠：Assessments conducted at weeks 2, 8 and 24
Acceptability assessments were assessed by Study Staff at study visits and by Participant Caregiver whilst at home. Participants' dose formulations were not restrictive as at each visit, the participant was given the option of taking the study drug as either a dispersible tablet or tablet formulation. At a visit, the participant could have been taking a dispersible tablet and at the next visit the same participant could have been taking a tablet formulation.
Assessments conducted at weeks 2, 8 and 24
Frequency of Cumulative Responses to Taste of Tablet Doses in an Acceptability Assessment
時間枠：Assessments conducted at weeks 2, 8 and 24
Acceptability assessments were assessed by Study Staff at study visits and by Participant Caregiver whilst at home. Participants' dose formulations were not restrictive as at each visit, the participant was given the option of taking the study drug as either a dispersible tablet or tablet formulation. At a visit, the participant could have been taking a dispersible tablet and at the next visit the same participant could have been taking a tablet formulation.
Assessments conducted at weeks 2, 8 and 24
Frequency of Cumulative Responses to Administration of Tablet Doses in an Acceptability Assessment
時間枠：Assessments conducted at weeks 2, 8 and 24
Acceptability assessments were assessed by Study Staff at study visits and by Participant Caregiver whilst at home. Participants' dose formulations were not restrictive as at each visit, the participant was given the option of taking the study drug as either a dispersible tablet or tablet formulation. At a visit, the participant could have been taking a dispersible tablet and at the next visit the same participant could have been taking a tablet formulation.
Assessments conducted at weeks 2, 8 and 24
Age Effect on Bioavailability DLM
時間枠：Approximately Week 2
Plasma concentrations are used to determine age effect on bioavailability. The age covariate describes the fold change in bioavailability for each respective age group of 0-1 year and 1-2 years, with participants aged >2 to <18 years used as the reference group. Study arms were combined for the analysis of age effect.
Approximately Week 2
Age Effect on Fraction Metabolised From Delaminid to DM-6705
時間枠：Approximately Week 2
Plasma concentrations are used to determine age effect on bioavailability. The age covariate describes the fold change in bioavailability for each respective age group of 0-1 year and 1-2 years, with participants aged >2 to <18 years used as the reference group. Study arms were combined for the analysis of age effect.
Approximately Week 2
Dose Effect on Bioavailability DLM
時間枠：Approximately Week 2
Plasma concentrations are used to determine dose effect on bioavailability. For doses > 50 mg the bioavailability is described by F=(dose/100)-0.66. The participants receiving the dose 100 mg are the reference group and the dose effect of doses 15-20mg, 25mg and 50mg on the bioavailability are compared to the reference group and the fold change is presented. Study arms were combined for the analysis of dose effect.
Approximately Week 2

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。

スポンサー

National Institute of Allergy and Infectious Diseases (NIAID)

協力者

Otsuka Pharmaceutical Development & Commercialization, Inc.

捜査官

  • スタディチェア：Ethel Weld, MD、Johns Hopkins University
  • スタディチェア：Anthony Garcia-Prats, MD、University of Wisconsin, Madison

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

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 (実際)

2019年2月18日

一次修了 (実際)

2025年4月22日

研究の完了 (実際)

2025年5月29日

試験登録日

最初に提出

2017年5月1日

QC基準を満たした最初の提出物

2017年5月3日

最初の投稿 (実際)

2017年5月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月25日

QC基準を満たした最後の更新が送信されました

2026年5月31日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • IMPAACT 2005
  • 20721 (レジストリ識別子：DAIDS-ES Registry Number)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

匿名化後に公開される結果の根底にある個々の参加者データ。

IPD 共有時間枠

出版後 3 か月から始まり、NIH による国際母性小児青年エイズ臨床試験 (IMPAACT) ネットワークの資金提供期間を通じて利用できます。

IPD 共有アクセス基準

  • 誰と？

    • IMPAACT ネットワークによって承認されたデータの使用について、方法論的に適切な提案を行う研究者。

  • どのような種類の分析に使用しますか?

    • IMPAACT ネットワークによって承認された提案の目的を達成するため。

  • データはどのようなメカニズムで利用可能になりますか?

    • 研究者は、https://www.impaactnetwork.org/resources/study-proposals.htm の IMPAACT「データ要求」フォームを使用して、データへのアクセス要求を送信できます。 承認された提案の研究者は、データを受け取る前に IMPAACT データ使用契約に署名する必要があります。

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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。

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条件

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