Falciparum MalariaAsintMalNCT04422015
Biological Mechanisms in Afebrile P. Falciparum Malaria
An observational study of Falciparum Malaria, run by Alfredo Mayor at 1 site in Mozambique.
Trial summary
This project aims to disentangle the role of host immune resistance and disease tolerance in afebrile malaria infections, with the goal of guiding context-adapted tactics to target this hidden reservoir, as well as to develop new approaches to clear malaria infection and reduce its severity through host-directed… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Falciparum Malaria
- How many people
- 475 participants
- Where
- 1 siteMozambique
- Study dates
- 1 Mar 2020to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy individuals (temperature below 37.5ºC) with a P. falciprum infection confirmed by RDT and microscopy
Who may be able to join
- Age ≥ 18 years and ≤60 years
- A positive RDT and microscopy for P. falciparum
- Axillary temperature < 37.5ºC without history of fever during the last 24h
- No danger signals for severe malaria (Impaired consciousness, respiratory distress, multiple convulsions, prostration, shock, abnormal bleeding, jaundice)
- Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
- Signed informed consent after explaining the purpose of the study
Who cannot join
- Age <18 years or >60 years
- Axillary temperature ≥37.5ºC
- Reported pregnancy
- Presence of any sign/symptom of malaria (Vomiting, diarrhea, weakness, dizziness, fainting, itching, urticarial)
- Presence of any other co-existing clinical condition that would not allow the individual to be considered a "healthy" afebrile carrier
- Having received antimalarial medication in the preceding 30 days.
Trial locations and contacts
1 site in 1 country.
Mozambique1 site
Fundação Manhiça/Manhiça Health Research Center
Manhiça, 1929
About this study
Official title: Unravelling Disease Tolerance and Host Resistance in Afebrile P. Falciparum Infections: a Prospective Study in Mozambican Adults
This project aims to disentangle the role of host immune resistance and disease tolerance in afebrile malaria infections, with the goal of guiding context-adapted tactics to target this hidden reservoir, as well as to develop new approaches to clear malaria infection and reduce its severity through host-directed therapies.
Read the detailed description
Asymptomatic Plasmodium falciparum (Pf) infections debilitate the health of affected population while representing a hidden source of parasite transmission that can compromise elimination efforts. The lack of consensus on the best strategy to deal with this asymptomatic reservoir is partly due to the poor knowledge on the biological mechanisms underlying these subclinical infections. Preliminary results in Mozambique show that afebrile adults with a Pf infection detected by rapid diagnostic tests can progress to fever (10%), clear the infection (20%) and stabilize at low-density (50%) or high-density (20%) parasitemias. The study hypothesis is that these four main trajectories are driven by antibodies against Pf variant antigens, codified by the var gene family and expressed on the surface of infected erythrocytes, which would clear the infection unless the parasites develop immune evasion mechanisms, and by tolerance factors that minimize parasite-induced pathology and sustains host homeostasis.With the overarching goal of identifying key biological factors sustaining afebrile malaria infections, this project will establish a cohort of afebrile Mozambican adults followed during one month to identify subjects who can reduce pathogen load and eventually clear the infection, those who maintain infections at high-density and afebrile levels (tolerant), and those who fail to establish disease tolerance and progress to fever. Circulating and overall parasite biomass will be quantified, and new infections will be identified during follow-up using next-generation sequencing. Clinical samples from individuals with low and high parasite densities will be used to test whether parasitological trajectories of afebrile Pf infections correlate with host antibody immunity against erythrocyte surface antigens and the transcription of Pf var genes involved in cytoadhesion and immune evasion. Cytometry by time of flight and global mass spectrometry will be applied on clinical samples from afebrile individuals with high parasite densities (tolerant) and those progressing to fever (non-tolerant) to identify leukocyte populations and metabolic pathways involved in the regulation of inflammation, tissue damage and normoglycemia that support host-parasite relationships at afebrile levels. The expected outcome of this project is the identification of key molecular drivers of afebrile Pf infections for a better understanding of the relevance of these infections in different transmission setting which may require context-specific control approaches, as well as for the development of new tools to achieve sterilizing immunity and enhance disease tolerance.
- Conditions
- Falciparum Malaria
- Being tested
- No intervention
- Keywords
- afebrile, resistance, tolerance
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of individuals developing fever
Development of axilary temperature higher or equal than 37.5ºC
Measured: 1 month
Secondary outcomes (2)
Proportion of individuals clearing the infection
Clearance of parasite infection as detected by qPCR
Measured: 1 month
Proportion of individuals maintaining infections without fever
Confirmed P. falciparum ifection at day 28 by qPCR
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Mar 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Falciparum MalariaStudies 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
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alfredo Mayor
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Investigação em Saúde de Manhiça, Stanford University, University of Florida
- Responsible party
- Sponsor-investigator, Alfredo Mayor, Barcelona Institute for Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422015
- Sponsor's protocol ID
- 1R01AI150521
- Acronym
- AsintMal
- Status last verified
- Aug 2023
- First submitted
- 4 Jun 2020
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unravelling Disease Tolerance and Host Resistance in Afebrile P. Falciparum Infections: a Prospective Study in Mozambican Adults
- ClinicalTrials.gov ID
- NCT04422015
- Acronym / sponsor ID
- AsintMal / 1R01AI150521
- Conditions
- Falciparum Malaria
- Keywords
- afebrile, resistance, tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Alfredo MayorUniversity, hospital or other
- Collaborators
- Centro de Investigação em Saúde de Manhiça, Stanford University, University of Florida
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 9 Jun 2020 (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.
This project aims to disentangle the role of host immune resistance and disease tolerance in afebrile malaria infections, with the goal of guiding context-adapted tactics to target this hidden reservoir, as well as to develop new approaches to clear malaria infection and reduce its severity through host-directed therapies.
Detailed description
Asymptomatic Plasmodium falciparum (Pf) infections debilitate the health of affected population while representing a hidden source of parasite transmission that can compromise elimination efforts. The lack of consensus on the best strategy to deal with this asymptomatic reservoir is partly due to the poor knowledge on the biological mechanisms underlying these subclinical infections. Preliminary results in Mozambique show that afebrile adults with a Pf infection detected by rapid diagnostic tests can progress to fever (10%), clear the infection (20%) and stabilize at low-density (50%) or high-density (20%) parasitemias. The study hypothesis is that these four main trajectories are driven by antibodies against Pf variant antigens, codified by the var gene family and expressed on the surface of infected erythrocytes, which would clear the infection unless the parasites develop immune evasion mechanisms, and by tolerance factors that minimize parasite-induced pathology and sustains host homeostasis.With the overarching goal of identifying key biological factors sustaining afebrile malaria infections, this project will establish a cohort of afebrile Mozambican adults followed during one month to identify subjects who can reduce pathogen load and eventually clear the infection, those who maintain infections at high-density and afebrile levels (tolerant), and those who fail to establish disease tolerance and progress to fever. Circulating and overall parasite biomass will be quantified, and new infections will be identified during follow-up using next-generation sequencing. Clinical samples from individuals with low and high parasite densities will be used to test whether parasitological trajectories of afebrile Pf infections correlate with host antibody immunity against erythrocyte surface antigens and the transcription of Pf var genes involved in cytoadhesion and immune evasion. Cytometry by time of flight and global mass spectrometry will be applied on clinical samples from afebrile individuals with high parasite densities (tolerant) and those progressing to fever (non-tolerant) to identify leukocyte populations and metabolic pathways involved in the regulation of inflammation, tissue damage and normoglycemia that support host-parasite relationships at afebrile levels. The expected outcome of this project is the identification of key molecular drivers of afebrile Pf infections for a better understanding of the relevance of these infections in different transmission setting which may require context-specific control approaches, as well as for the development of new tools to achieve sterilizing immunity and enhance disease tolerance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy individuals (temperature below 37.5ºC) with a P. falciprum infection confirmed by RDT and microscopy
Key inclusion criteria (6 listed)
- Age ≥ 18 years and ≤60 years
- A positive RDT and microscopy for P. falciparum
- Axillary temperature < 37.5ºC without history of fever during the last 24h
- No danger signals for severe malaria (Impaired consciousness, respiratory distress, multiple convulsions, prostration, shock, abnormal bleeding, jaundice)
- Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
Key exclusion criteria (6 listed)
- Age <18 years or >60 years
- Axillary temperature ≥37.5ºC
- Reported pregnancy
- Presence of any sign/symptom of malaria (Vomiting, diarrhea, weakness, dizziness, fainting, itching, urticarial)
- Presence of any other co-existing clinical condition that would not allow the individual to be considered a "healthy" afebrile carrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Proportion of individuals developing fever
Time frame: 1 month
Development of axilary temperature higher or equal than 37.5ºC
2 secondary outcomes
Proportion of individuals clearing the infection
Time frame: 1 month
Proportion of individuals maintaining infections without fever
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Falciparum Malaria, run by Alfredo Mayor at 1 site in Mozambique.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mozambique. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of individuals developing fever (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2023.