A Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants
2026年7月15日 更新者：Novartis Pharmaceuticals
A Prospective Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants With Symptomatic Cryptosporidiosis in Endemic Countries
This study aims to characterize the pediatric cryptosporidiosis disease profile with respect to clinical presentation.
調査の概要
状態
募集
条件
研究の種類
観察的
入学 (推定)
30
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。
研究連絡先
- 名前：Novartis Pharmaceuticals
- 電話番号：+41613241111
- メール：novartis.email@novartis.com
研究連絡先のバックアップ
- 名前：Novartis Pharmaceuticals
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
サンプリング方法
非確率サンプル
調査対象母集団
Pediatric participants presenting with diarrhea and testing positive for Cryptosporidium by QuikChek™ and microscopy.
説明
Inclusion criteria:
- Age 6 months to 59 months with diarrhea according to the World Health Organization (WHO) criteria (≥3 loose stools daily for at least 2 days)
- QuikChek™ and Stool microscopy positive for Cryptosporidium at screening
- Acute (<7 days), prolonged (lasting 7-13 days), persistent (lasting 14-28 days) or chronic (lasting >28 days) diarrheal illness (≥3 loose stools daily, as defined by WHO) at screening
- Normal nutritional status, mildly-to-moderately acutely malnourished, or severely acutely malnourished according to WHO definitions (number of participants with severe acute malnutrition will be capped) at screening
- Parent or primary caregiver is willing to provide informed consent and to comply with study procedures, including provision of whole stool samples at the scheduled time points and willing to be followed up to 21 days
Exclusion criteria:
- Bloody diarrhea, defined as diarrhea with visible blood in stool as observed by the study team member performing the screening or reported by parent/primary caregiver
- Other morbidity requiring emergency medical care in an intensive care setting at the time of screening
- Coincident non-enteric infection including upper or lower respiratory infection at screening
- Any participant whose parent or primary caregiver is unwilling or unable to cooperate with study procedures, in the investigator's opinion
- If the parent/primary caregiver managing care of the patient has travel plans out of the study area that would preclude clinic or in-home study visits during the expected study follow-up period
Other protocol-defined inclusion/exclusion criteria may apply.
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
コホートと介入
グループ/コホート |
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Cryptosporidiosis Cohort
Pediatric participants with diarrhea due to Cryptosporidium infection.
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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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Number and Percentage of Participants by Chronicity of Diarrhea
時間枠：Baseline
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Diarrhea chronicity categories:
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Baseline
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Number and Percentage of Participants by Severity of Dehydration
時間枠：Baseline, Days 3, 7, 14 and up to Day 21
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Dehydration severity categories:
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Baseline, Days 3, 7, 14 and up to Day 21
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Time to Resolution of Diarrhea and Dehydration
時間枠：Baseline, Days 3, 7, 14 and up to Day 21
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Baseline, Days 3, 7, 14 and up to Day 21
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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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Association of Diarrheal Chronicity With Age
時間枠：Baseline
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Association of diarrheal chronicity with age will be assessed using the Kruskal-Wallis test.
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Baseline
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Association of Diarrheal Chronicity With Height
時間枠：Baseline
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Association of diarrheal chronicity with height will be assessed using the Kruskal-Wallis test.
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Baseline
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Association of Diarrheal Chronicity With Weight
時間枠：Baseline
|
Association of diarrheal chronicity with weight will be assessed using the Kruskal-Wallis test.
|
Baseline
|
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Association of Diarrheal Chronicity With Sex
時間枠：Baseline
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Association of diarrheal chronicity with sex will be assessed using the Fisher exact test.
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Baseline
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Association of Diarrheal Chronicity With HIV Status
時間枠：Baseline
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Association of diarrheal chronicity with HIV status will be assessed using the Fisher exact test.
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Baseline
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Association of Diarrheal Chronicity With Malnutrition
時間枠：Baseline
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Association of diarrheal chronicity with malnutrition will be assessed using the Fisher exact test.
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Baseline
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Association of Diarrheal Chronicity With Growth Faltering
時間枠：Baseline
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Association of diarrheal chronicity with growth faltering will be assessed using the Fisher exact test.
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Baseline
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Association of Diarrheal Chronicity With Early Weaning
時間枠：Baseline
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Association of diarrheal chronicity with early weaning will be assessed using the Fisher exact test.
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Baseline
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Association of Diarrheal Chronicity With Non-Exclusive Breast Feeding
時間枠：Baseline
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Association of diarrheal chronicity with early non-exclusive breast feeding will be assessed using the Fisher exact test.
|
Baseline
|
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Association of Dehydration Severity With Age
時間枠：Baseline, Days 3, 7, 14 and up to Day 21
|
Association of dehydration severity with age will be assessed using the Kruskal-Wallis test.
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Baseline, Days 3, 7, 14 and up to Day 21
|
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Association of Dehydration Severity With Height
時間枠：Baseline, Days 3, 7, 14 and up to Day 21
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Association of dehydration severity with height will be assessed using the Kruskal-Wallis test.
|
Baseline, Days 3, 7, 14 and up to Day 21
|
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Association of Dehydration Severity With Weight
時間枠：Baseline, Days 3, 7, 14 and up to Day 21
|
Association of dehydration severity with weight will be assessed using the Kruskal-Wallis test.
|
Baseline, Days 3, 7, 14 and up to Day 21
|
|
Association of Dehydration Severity With Sex
時間枠：Baseline, Days 3, 7, 14 and up to Day 21
|
Association of dehydration severity with sex will be assessed using the Fisher exact test.
|
Baseline, Days 3, 7, 14 and up to Day 21
|
|
Association of Dehydration Severity With HIV Status
時間枠：Baseline, Days 3, 7, 14 and up to Day 21
|
Association of dehydration severity with HIV status will be assessed using the Fisher exact test.
|
Baseline, Days 3, 7, 14 and up to Day 21
|
|
Association of Dehydration Severity With Malnutrition
時間枠：Baseline, Days 3, 7, 14 and up to Day 21
|
Association of dehydration severity with malnutrition will be assessed using the Fisher exact test.
|
Baseline, Days 3, 7, 14 and up to Day 21
|
|
Association of Dehydration Severity With Growth Faltering
時間枠：Baseline, Days 3, 7, 14 and up to Day 21
|
Association of dehydration severity with growth faltering will be assessed using the Fisher exact test.
|
Baseline, Days 3, 7, 14 and up to Day 21
|
|
Association of Dehydration Severity With Early Weaning
時間枠：Baseline, Days 3, 7, 14 and up to Day 21
|
Association of dehydration severity with early weaning will be assessed using the Fisher exact test.
|
Baseline, Days 3, 7, 14 and up to Day 21
|
|
Association of Dehydration Severity With Non-Exclusive Breast Feeding
時間枠：Baseline, Days 3, 7, 14 and up to Day 21
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Association of dehydration severity with early non-exclusive breast feeding will be assessed using the Fisher exact test.
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Baseline, Days 3, 7, 14 and up to Day 21
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Number of Oocysts
時間枠：Baseline, Days 3, 7, 14 and up to Day 21
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Baseline, Days 3, 7, 14 and up to Day 21
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Proportion of Participants Shedding Oocysts
時間枠：Baseline, Days 3, 7, 14 and up to Day 21
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Baseline, Days 3, 7, 14 and up to Day 21
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Number of Participants by Parasite Presence Measured by Microscopy and the QuikChek™ Cryptosporidium Rapid Diagnostic Test (RDT)
時間枠：Baseline, Days 3, 7, 14 and up to Day 21
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Baseline, Days 3, 7, 14 and up to Day 21
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Number of Participants Screened for Each Site by Time of Year
時間枠：Baseline
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Number of participants screened (i.e., present with diarrheal illness) for each site by time of year (i.e., per season).
|
Baseline
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Number of Participants Enrolled for Each Site by Time of Year
時間枠：Baseline
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Number of participants enrolled (i.e., Cryptosporidium positive) for each site by time of year (i.e., per season).
|
Baseline
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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。
スポンサー
捜査官
- スタディディレクター：Novartis Pharmaceuticals、Novartis Pharmaceuticals
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)
2026年1月9日
一次修了 (推定)
2027年5月19日
研究の完了 (推定)
2027年5月19日
試験登録日
最初に提出
2026年6月29日
QC基準を満たした最初の提出物
2026年7月15日
最初の投稿 (実際)
2026年7月21日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月21日
QC基準を満たした最後の更新が送信されました
2026年7月15日
最終確認日
2026年7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。