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Community-Based Cohort Study of Hidden Malaria Infections, Diagnostic Gaps, & Mosquito Vector Dynamics in Odisha, India (CSCMi3)

2026年8月10日 更新者:Sam Wassmer、London School of Hygiene and Tropical Medicine

The Center for the Study of Complex Malaria in India (CSCMi 3.0): Hidden Plasmodium Infections: Reservoirs, Impact, and Biomarker Discovery

The goal of this prospective cohort study is to understand the factors responsible for the persistence of malaria transmission in some areas despite intensive control efforts. The study will measure the prevalence and incidence of asymptomatic and sub-patent Plasmodium infections and examine the factors that contribute to persistent transmission among residents of malaria-endemic areas of Odisha, India.

The main questions the study aims to answer are: Do asymptomatic and sub-patent Plasmodium infections contribute to persistent malaria transmission in endemic areas of Odisha? What is the frequency of false-negative results and incorrect species identification when microscopy and rapid diagnostic tests (RDTs) are compared with PCR? How is malaria epidemiology changing over time across areas with different transmission patterns, including shifts in Plasmodium species? What is the prevalence of asymptomatic gametocyte carriers, and how might they contribute to ongoing transmission? What are the characteristics and distribution of mosquito vectors in and around households, and how do they relate to transmission patterns? Can novel host- and parasite-derived biomarkers improve the detection of malaria infections, including asymptomatic cases?

Participants will provide blood samples for malaria testing by microscopy, RDT and PCR. A subset will provide additional samples for biomarker analysis as part of a nested sub-study. Participants will be followed over time to measure malaria infection prevalence, incidence and changes in transmission patterns. They will also take part in household-level assessments, including surveys and mosquito vector monitoring around their homes.

調査の概要

詳細な説明

Malaria transmission has declined in many parts of India as a result of expanded control efforts. However, persistent transmission continues in several regions despite high intervention coverage. Increasing evidence suggests that asymptomatic and subpatent Plasmodium infections may form an important hidden reservoir that sustains transmission and complicates malaria elimination. These infections are often missed by routine diagnostic methods such as microscopy and rapid diagnostic tests (RDTs), particularly in low-transmission or pre-elimination settings.

Local mosquito vector dynamics, including species composition, density and behaviour, are also likely to play a critical role in sustaining residual transmission, but remain insufficiently characterised in these settings.

This study is part of the Center for the Study of Complex Malaria in India 3 (CSCMi-3) and aims to characterise the epidemiology and biological determinants of hidden malaria infections in Odisha, India. It will also examine how vector, human and parasite factors interact to sustain transmission. The study is a prospective, community-based cohort conducted in selected rural villages across three endemic districts, representing different malaria transmission settings. Participants will be enrolled through household-based community surveys and followed longitudinally to monitor malaria infection dynamics over time.

The parent cohort study will enrol approximately 3,000 individuals, who will be followed through repeated visits to estimate the prevalence and incidence of asymptomatic malaria infections. The study will also assess the frequency of false-negative results and species misclassification by comparing routine diagnostic methods with molecular detection. In addition, it will evaluate Pfhrp2/Pfhrp3 gene deletions and explore potential shifts in Plasmodium species composition over time. Blood samples collected during study visits will be used for parasitological testing and laboratory analyses to better understand the persistence of malaria transmission.

Concurrent entomological surveys will be conducted in and around participant households to characterise mosquito vector species, density and seasonal patterns, and to examine their relationship with household-level infection patterns and ongoing transmission.

A nested biomarker sub-cohort will include a subset of participants who will undergo more frequent sampling to investigate circulating host- and parasite-derived biomarkers associated with malaria infection and transmission. These data will support the identification of biological indicators that may improve the detection of hidden infections and inform malaria surveillance strategies in elimination settings.

In parallel with the active community-based cohort, routinely collected malaria surveillance data from the Government of Odisha will be obtained for the study villages throughout the study period. These data will be used to characterise temporal trends in routine malaria surveillance, compare passive and active malaria case detection, and generate evidence to inform malaria surveillance and elimination strategies.

Together, the study will generate longitudinal epidemiological, diagnostic, biomarker and entomological data to improve understanding of residual malaria transmission and support evidence-based malaria surveillance, control and elimination strategies in India.

研究の種類

観察的

入学 (推定)

3000

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

研究場所

    • Odisha
      • Bhubaneswar、Odisha、インド、751023
        • 募集
        • ICMR-National Institute of Health Research
        • コンタクト:
        • 主任研究者:
          • Sanghamitra Pati, MD MPH PhD
        • 主任研究者:
          • Madhusmita Bal, PhD
      • Raurkela、Odisha、インド、769042
        • 募集
        • Community Welfare Society Hospital (CWSH)
        • コンタクト:
        • 主任研究者:
          • Sanjib Mohanty, MBBS MD
        • 主任研究者:
          • Praveen Kishore Sahu, PhD

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
  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

確率サンプル

調査対象母集団

Community residents living in selected rural villages in three districts of Odisha, India (Keonjhar, Boudh, and Malkangiri), representing different malaria transmission settings. Participants include males and females aged 12 months to 69 years who are enrolled through household-based community surveys and followed longitudinally to assess malaria infection, transmission dynamics, and biomarkers of infection. There are no restrictions based on residency duration, pregnancy status, social class, or underlying health conditions. For participants with severe anemia, study procedures are limited to finger-prick blood sampling in accordance with the study protocol.

説明

Inclusion Criteria:

  • Individuals 12 months to 69 years, all social classes, and all types of health status will be enrolled

Exclusion Criteria:

  • Individuals unable or unwilling to provide informed consent (or parental consent/assent for minors) Individuals unable to comply with study procedures or follow-up visits according to investigator judgement

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
Project 1
This prospective, community-based cohort will enrol approximately 3,000 participants from 15 villages across three districts of Odisha, India: Keonjhar, Boudh and Malkangiri, with five villages selected from each district. Participants aged 12 months to 69 years will be followed for four years, with study visits every six months before and after the monsoon season. At each visit, participants will undergo clinical assessment and finger-prick blood collection for malaria testing by rapid diagnostic test (RDT), microscopy and PCR. Samples will also be used for haemoglobin measurement and for the collection of plasma and erythrocytes for molecular and serological analyses, to monitor malaria epidemiology and transmission dynamics.
Project 2

This nested prospective sub-cohort will enroll approximately 1,000 participants selected from the parent cohort across six villages, with two villages selected from each district. Participants will be recruited from three villages, one per district, beginning at the 12-month visit of the parent study in Year 2, and from the remaining three villages, one per district, in Year 3.

Participants will undergo more frequent longitudinal sampling to characterise malaria transmission and infection dynamics using sero-epidemiology and circulating host- and parasite-derived biomarkers. Finger-prick blood samples will be collected for rapid diagnostic testing (RDT), microscopy, PCR-based detection of Plasmodium infection, and bead-based assays measuring anti-Plasmodium antibodies and other infection biomarkers.

Concurrent entomological assessments conducted as part of the parent cohort will provide context on vector dynamics in relation to observed infection patterns and transmission.

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
Prevalence and incidence of Plasmodium infection - Project 1
時間枠:Nine time points between Years 1 and 5, including one baseline visit and eight follow-up visits conducted every six months.
Prevalence and incidence of Plasmodium infection among study participants, determined by polymerase chain reaction (PCR)-based detection of Plasmodium species in finger-prick blood samples collected during longitudinal community surveys. The study will estimate the prevalence, incidence and persistence of asymptomatic, subpatent and submicroscopic infections, together with species-specific infections.
Nine time points between Years 1 and 5, including one baseline visit and eight follow-up visits conducted every six months.
Diagnostic performance of malaria microscopy and rapid diagnostic tests compared with PCR - Project 1
時間枠:Baseline and follow-up visits conducted every six months over five years.
Diagnostic performance of malaria microscopy and rapid diagnostic tests (RDTs) compared with PCR, assessed by false-negative and false-positive results, positive and negative predictive values, and species concordance for Plasmodium detection.
Baseline and follow-up visits conducted every six months over five years.
Novel circulating infection biomarkers of host and parasite origin - Biomarker Sub-study, Project 2
時間枠:Sixteen time points between Years 1 and 5, with eight time points each for Groups A and B.
Identification and quantification of circulating host- and parasite-derived biomarkers associated with malaria infection, using multiplex and molecular assays in longitudinal blood samples collected from the biomarker sub-cohort
Sixteen time points between Years 1 and 5, with eight time points each for Groups A and B.

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。

捜査官

  • 主任研究者:Samuel Wassmer, PhD、London School of Hygiene & Tropical Medicine, London
  • 主任研究者:Sanjib Mohanty, MBBS MD、Community Welfare Society Hospital, Odisha, India

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。

一般刊行物

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)

2025年5月2日

一次修了 (推定)

2029年5月31日

研究の完了 (推定)

2029年5月31日

試験登録日

最初に提出

2026年8月10日

QC基準を満たした最初の提出物

2026年8月10日

最初の投稿 (実際)

2026年8月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月18日

QC基準を満たした最後の更新が送信されました

2026年8月10日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 30518
  • U19AI181587 (米国 NIH グラント/契約)

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

De-identified individual participant data underlying the results reported in publications will be shared. This includes demographic data, clinical and laboratory measurements, malaria diagnostic results (RDT, microscopy, PCR), serological measurements, and selected entomological indicators collected during the study. Direct identifiers will be removed prior to data sharing.

IPD 共有時間枠

De-identified individual participant data and supporting documents will be available beginning after publication of the primary study results. Data will remain available for up to 5 years following publication, subject to institutional data governance and data sharing policies.

IPD 共有アクセス基準

De-identified individual participant data and supporting documents, including the study protocol, statistical analysis plan, informed consent forms and analytic code, will be made available to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed and approved by the study investigators and participating institutions. Access will be provided through a controlled data-sharing mechanism and may require a data-use agreement to ensure appropriate use of the data and protection of participant confidentiality. Only the data necessary to address the approved research question will be shared.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

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