タンザニアにおける臨床的重度感染症の幼児への亜鉛補給
タンザニアにおける臨床的重度感染症の幼児に対する亜鉛サプリメントの試験
Bacterial infections among young infants, including sepsis, meningitis, and pneumonia, continue to cause a substantial number of deaths globally. Zinc supplementation in combination with standard antibiotic therapy may represent a new intervention to reduce mortality and improve treatment outcomes for young infants with clinical severe infection.
The Investigators will conduct a randomized, double-blind, placebo-controlled trial of zinc supplementation among young infants 0-59 days with severe clinical infection. The trial will enroll 3,250 Tanzanian infants hospitalized with clinical severe infection as defined by WHO Integrated Management of Childhood Illness (IMCI) guidelines. Enrolled infants will receive standard clinical management including antibiotics and will be randomized to receive either a 14-day course of twice-daily 5 mg elemental zinc (10 mg per day) or a matching placebo regimen.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Christopher R Sudfeld, ScD
- 電話番号：(617) 432-5051
- メール：csudfeld@hsph.harvard.edu
研究場所
-
-
-
Dar es Salaam、タンザニア
- 募集
- Muhimbili University of Health and Allied Sciences
-
コンタクト：
- Karim P Manji, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Young infants aged 0-59 days
- Diagnosis of clinical severe infection (CSI)
- Ability to feed enterally
- Intend to stay in the study area for 90 days
- Provided informed consent
Exclusion Criteria:
- Prior use of zinc supplements during the current illness
- Receipt of antibiotics for >24 hours before enrollment
- Diarrhea at enrollment
- Signs suggestive of serious illness/condition that is not clinical severe infection
- Previously enrolled in the trial
- Enrolled in other research study
研究計画
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：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Zinc Supplementation
14-day regimen of twice-daily 5 mg elemental zinc supplements to be taken orally or by enteral feeding tube |
Dispersible zinc citrate tablets |
|
プラセボコンパレーター：Placebo
14-day regimen of twice-daily oral placebo supplements to be taken orally or by enteral feeding tube |
Dispersible placebo tablets |
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 |
|---|---|---|
|
Death
時間枠：90 Days
|
All-cause infant death |
90 Days
|
|
Treatment Failure
時間枠：From date of randomization until the date of first documented treatment failure or date of death from any cause during the initial hospitalization, whichever comes first, assessed up to 90 days
|
A composite endpoint of death during initial period of hospitalization, the need for additional respiratory support (either mechanical ventilation, or positive end expiratory pressure support) or the use of vasoactive medicines to support blood pressure or need to change antibiotics during the initial hospitalization |
From date of randomization until the date of first documented treatment failure or date of death from any cause during the initial hospitalization, whichever comes first, assessed up to 90 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Death during initial hospitalization
時間枠：Randomization to the date of initial hospitalization discharge, assessed up to 90 days
|
All-cause mortality during initial hospitalization |
Randomization to the date of initial hospitalization discharge, assessed up to 90 days
|
|
Duration of initial hospital stay
時間枠：Randomization to Day 90
|
Hours from randomization to initial hospitalization discharge |
Randomization to Day 90
|
|
Duration of signs of clinical severe infection
時間枠：Randomization to Day 90
|
Hours from randomization to the absence of any sign of clinical severe infection |
Randomization to Day 90
|
|
Diarrhea during initial hospital admission
時間枠：Randomization to the date of initial hospitalization discharge, assessed up to 90 days
|
Clinical diagnosis based on three or more loose or watery stools in the past 24 hours |
Randomization to the date of initial hospitalization discharge, assessed up to 90 days
|
|
Rate of vomiting related to regimen dosing
時間枠：Randomization to Day 15
|
Vomiting observed by study staff within 30 minutes of regimen dosing |
Randomization to Day 15
|
|
Re-hospitalization
時間枠：Date of initial hospitalization discharge to Day 90
|
Infant admitted and stayed overnight in health facility after being discharged from initial hospitalization |
Date of initial hospitalization discharge to Day 90
|
|
Presence of any sign of possible severe bacterial infection at Day 15
時間枠：Day 15
|
Presence of a clinical sign of possible severe bacterial infection, including: high body temperature ≥38°C, low body temperature <35.5°C , severe chest indrawing, movement only on stimulation or no movement at all, stopped feeding well or unable to feed at all, or convulsions. |
Day 15
|
|
Presence of any sign of possible severe bacterial infection at Day 90
時間枠：Day 90
|
Presence of a clinical sign of possible severe bacterial infection, including: high body temperature ≥38°C, low body temperature <35.5°C , severe chest indrawing, movement only on stimulation or no movement at all, stopped feeding well or unable to feed at all, or convulsions. |
Day 90
|
|
Proportion of Children with Diarrhea at Day 15 or Day 90
時間枠：Day 15 and Day 90
|
Maternal report of three or more loose or watery stools in the past 24 hours |
Day 15 and Day 90
|
|
Infant length-for-age z-score at Day 15
時間枠：Day 15
|
Infant length-for-age z-score by WHO Child Growth Standards |
Day 15
|
|
Infant length-for-age z-score at Day 90
時間枠：Day 90
|
Infant length-for-age z-score by WHO Child Growth Standards |
Day 90
|
|
Infant weight-for-age z-score at Day 15
時間枠：Day 15
|
Infant weight-for-age z-score by WHO Child Growth Standards |
Day 15
|
|
Infant weight-for-age z-score at Day 90
時間枠：Day 90
|
Infant weight-for-age z-score by WHO Child Growth Standards |
Day 90
|
|
Infant weight-for-length z-score at Day 15
時間枠：Day 15
|
Infant weight-for-length z-score by WHO Child Growth Standards |
Day 15
|
|
Infant weight-for-length z-score at Day 90
時間枠：Day 90
|
Infant weight-for-length z-score by WHO Child Growth Standard |
Day 90
|
|
Plasma zinc concentrations at Day 15
時間枠：Day 15
|
Infant plasma zinc concentration |
Day 15
|
協力者と研究者
捜査官
- 主任研究者：Christopher R Sudfeld, ScD、Harvard School of Public Health (HSPH)
- 主任研究者：Christopher P Duggan, MD、Harvard School of Public Health (HSPH) and Boston Children's Hospital
- 主任研究者：Karim P Manji, MD、Muhimbili University of Health and Allied Sciences
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB23-0138
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?
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
米国FDA規制機器製品の研究
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