Malaria, Asymptomatic ParasitaemiaCSCMi3NCT07770048
Community-Based Cohort Study of Hidden Malaria Infections, Diagnostic Gaps, & Mosquito Vector Dynamics in Odisha, India
An observational study of Malaria, Asymptomatic Parasitaemia, run by London School of Hygiene and Tropical Medicine at 2 sites in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 months to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Asymptomatic Parasitaemia
- How many people
- 3,000 participants
- Where
- 2 sitesIndia
- Study dates
- 2 May 2025to 31 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 69 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Individuals 12 months to 69 years, all social classes, and all types of health status will be enrolled
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites, 2 recruiting
- Recruiting
ICMR-National Institute of Health Research
Bhubaneswar, Odisha, 751023
Madhusmita Bal, PhD, +916742301322, bal.madhusmita@icmr.gov.in
Sanghamitra Pati, MD MPH PhD
- Recruiting
Community Welfare Society Hospital (CWSH)
Raurkela, Odisha, 769042
Praveen Kishore Sahu, PhD, +91 8895501174, drpraveenksahu@cwshospital.org
Sanjib Mohanty, MBBS MD
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Malaria, Asymptomatic Parasitaemia
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and incidence of Plasmodium infection - Project 1
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.
Measured: 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
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.
Measured: 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
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
Measured: Sixteen time points between Years 1 and 5, with eight time points each for Groups A and B.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start2 May 2025
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Malaria, Asymptomatic ParasitaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Community Welfare Society Hospital (CWSH), Rourkela, Odisha, India, ICMR-National Institute of Health Research, Bhubaneswar, Odisha, India
- Responsible party
- Principal investigator, Sam Wassmer, London School of Hygiene and Tropical Medicine
- Investigators
- Samuel Wassmer, PhD, Principal investigator, London School of Hygiene & Tropical Medicine, LondonSanjib Mohanty, MBBS MD, Principal investigator, Community Welfare Society Hospital, Odisha, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770048
- Sponsor's protocol ID
- 30518
- Other IDs
- U19AI181587
- Acronym
- CSCMi3
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Longley RJ, White MT, Takashima E, Brewster J, Morita M, Harbers M, Obadia T, Robinson LJ, Matsuura F, Liu ZSJ, Li-Wai-Suen CSN, Tham WH, Healer J, Huon C, Chitnis CE, Nguitragool W, Monteiro W, Proietti C, Doolan DL, Siqueira AM, Ding XC, Gonzalez IJ, Kazura J, Lacerda M, Sattabongkot J, Tsuboi T, Mueller I. Development and validation of serological markers for detecting recent Plasmodium vivax infection. Nat Med. 2020 May;26(5):741-749. doi: 10.1038/s41591-020-0841-4. Epub 2020 May 11.
PubMed 32405064Khan N, Awasthi G, Das A. How can the complex epidemiology of malaria in India impact its elimination? Trends Parasitol. 2023 Jun;39(6):432-444. doi: 10.1016/j.pt.2023.03.006. Epub 2023 Apr 6.
PubMed 37031071Kumari P, Sinha S, Gahtori R, Yadav CP, Pradhan MM, Rahi M, Pande V, Anvikar AR. Prevalence of Asymptomatic Malaria Parasitemia in Odisha, India: A Challenge to Malaria Elimination. Am J Trop Med Hyg. 2020 Oct;103(4):1510-1516. doi: 10.4269/ajtmh.20-0018.
PubMed 32783792van Eijk AM, Sutton PL, Ramanathapuram L, Sullivan SA, Kanagaraj D, Priya GSL, Ravishankaran S, Asokan A, Sangeetha V, Rao PN, Wassmer SC, Tandel N, Patel A, Desai N, Choubey S, Ali SZ, Barla P, Oraon RR, Mohanty S, Mishra S, Kale S, Bandyopadhyay N, Mallick PK, Huck J, Valecha N, Singh OP, Pradhan K, Singh R, Sharma SK, Srivastava HC, Carlton JM, Eapen A. The burden of submicroscopic and asymptomatic malaria in India revealed from epidemiology studies at three varied transmission sites in India. Sci Rep. 2019 Nov 19;9(1):17095. doi: 10.1038/s41598-019-53386-w.
PubMed 31745160Carlton JM, Eapen A, Kessler A, Anvikar AR, Hoffmann A, Singh OP, Sullivan SA, Albert S, Sahu PK, Mohanty S, Wassmer SC. Advances in Basic and Translational Research as Part of the Center for the Study of Complex Malaria in India. Am J Trop Med Hyg. 2022 Oct 11;107(4_Suppl):97-106. doi: 10.4269/ajtmh.21-1333. Print 2022 Oct 11.
PubMed 36228919
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Center for the Study of Complex Malaria in India (CSCMi 3.0): Hidden Plasmodium Infections: Reservoirs, Impact, and Biomarker Discovery
- ClinicalTrials.gov ID
- NCT07770048
- Acronym / sponsor ID
- CSCMi3 / 30518
- Conditions
- Malaria, Asymptomatic Parasitaemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Community Welfare Society Hospital (CWSH), Rourkela, Odisha, India, ICMR-National Institute of Health Research, Bhubaneswar, Odisha, India
- Study start
- 2 May 2025 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 months to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Individuals 12 months to 69 years, all social classes, and all types of health status will be enrolled
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence and incidence of Plasmodium infection - Project 1
Time frame: 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.
Diagnostic performance of malaria microscopy and rapid diagnostic tests compared with PCR - Project 1
Time frame: 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.
Novel circulating infection biomarkers of host and parasite origin - Biomarker Sub-study, Project 2
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 32405064Longley RJ, White MT, Takashima E, Brewster J, Morita M, Harbers M, Obadia T, Robinson LJ, Matsuura F, Liu ZSJ, Li-Wai-Suen CSN, Tham WH, Healer J, Huon C, Chitnis CE, Nguitragool W, Monteiro W, Proietti C, Doolan DL, Siqueira AM, Ding XC, Gonzalez IJ, Kazura J, Lacerda M, Sattabongkot J, Tsuboi T, Mueller I. Development and validation of serological markers for detecting recent Plasmodium vivax infection. Nat Med. 2020 May;26(5):741-749. doi: 10.1038/s41591-020-0841-4. Epub 2020 May 11.
- Background: PubMed 37031071Khan N, Awasthi G, Das A. How can the complex epidemiology of malaria in India impact its elimination? Trends Parasitol. 2023 Jun;39(6):432-444. doi: 10.1016/j.pt.2023.03.006. Epub 2023 Apr 6.
- Background: PubMed 32783792Kumari P, Sinha S, Gahtori R, Yadav CP, Pradhan MM, Rahi M, Pande V, Anvikar AR. Prevalence of Asymptomatic Malaria Parasitemia in Odisha, India: A Challenge to Malaria Elimination. Am J Trop Med Hyg. 2020 Oct;103(4):1510-1516. doi: 10.4269/ajtmh.20-0018.
- Background: PubMed 31745160van Eijk AM, Sutton PL, Ramanathapuram L, Sullivan SA, Kanagaraj D, Priya GSL, Ravishankaran S, Asokan A, Sangeetha V, Rao PN, Wassmer SC, Tandel N, Patel A, Desai N, Choubey S, Ali SZ, Barla P, Oraon RR, Mohanty S, Mishra S, Kale S, Bandyopadhyay N, Mallick PK, Huck J, Valecha N, Singh OP, Pradhan K, Singh R, Sharma SK, Srivastava HC, Carlton JM, Eapen A. The burden of submicroscopic and asymptomatic malaria in India revealed from epidemiology studies at three varied transmission sites in India. Sci Rep. 2019 Nov 19;9(1):17095. doi: 10.1038/s41598-019-53386-w.
- Background: PubMed 36228919Carlton JM, Eapen A, Kessler A, Anvikar AR, Hoffmann A, Singh OP, Sullivan SA, Albert S, Sahu PK, Mohanty S, Wassmer SC. Advances in Basic and Translational Research as Part of the Center for the Study of Complex Malaria in India. Am J Trop Med Hyg. 2022 Oct 11;107(4_Suppl):97-106. doi: 10.4269/ajtmh.21-1333. Print 2022 Oct 11.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samuel Wassmer, PhD principal investigator
London School of Hygiene & Tropical Medicine, London
Sanjib Mohanty, MBBS MD principal investigator
Community Welfare Society Hospital, Odisha, India
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, Asymptomatic Parasitaemia, run by London School of Hygiene and Tropical Medicine at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel Wassmer, PhD (+44 7930357115, sam.wassmer@lshtm.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and incidence of Plasmodium infection - Project 1 (time frame: Nine time points between Years 1 and 5, including one baseline visit and eight follow-up visits conducted every six months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07770048, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.