MalariaNCT00850655
Genetic Association Mapping of Malaria Resistance in Anopheles Gambiae
An observational study of Malaria, run by University of Minnesota at 1 site in United States.
Trial summary
This is a study of the genetics of malaria transmission by the mosquito vector in Africa, Anopheles gambiae. The study focuses on the mosquito vector, not the human subjects infected with malaria. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Malaria
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Mar 2015
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: community sample
Who may be able to join
- 5-10 years old, and general good health
Who cannot join
- Outside age group
- Specific diagnosable health problems
- General poor health
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Saint Paul, Minnesota, 55108
About this study
This is a study of the genetics of malaria transmission by the mosquito vector in Africa, Anopheles gambiae. The study focuses on the mosquito vector, not the human subjects infected with malaria. DNA extracted from infected mosquitoes will be analyzed genetically by microsatellite and single-nucleotide polymorphisms (SNPs) to identify mosquito genes that control mosquito resistance to malaria parasites.
Read the detailed description
A standard diagnostic blood smear from a drop of blood will be carried out on 20 study subjects once per month. One malaria-positive subject from among the 20 will be asked to donate 5cc of blood, also no more frequently than once per month. The blood will be placed in a water-jacketed heated membrane feeding device that will be positioned on top of a cage of mosquitoes. The mosquitoes are attracted to the warmth and drink the blood through the artificial skin-like membrane. The goal of the research is to study the infected mosquitoes. No studies will be carried out on the human subjects. The point of human subjects involvement is to obtain the naturally malaria-infected blood for feeding of mosquitoes. After blood feeding, the mosquitoes are held in an environmental chamber for one week, at which time they are dissected to count numbers of malaria parasites developing on the mosquito stomach wall. This number constitutes the quantitative phenotype, and we extract genomic DNA from the carcass for genetic marker typing, which constitutes the genotype. Genetic linkage analysis identifies markers near genes that control parasite number, thus resistance or susceptibility to parasite infection.
- Conditions
- Malaria
- Medical subject headings
- Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
mosquito infection
Protocol involves non-invasive blood draw from participant screened by finger-prick for infection with malaria. Drawn blood (0.5cc) is placed in artificial membrane feeder for feeding of mosquitoes. Primary outcome is infection of mosquitoes, detectable one week after blood feeding.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startMar 2008
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth D Vernick, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850655
- Sponsor's protocol ID
- 0607M88827
- Status last verified
- Oct 2016
- First submitted
- 16 Oct 2008
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Association Mapping of Malaria Resistance in Anopheles Gambiae
- ClinicalTrials.gov ID
- NCT00850655
- Acronym / sponsor ID
- 0607M88827
- Conditions
- Malaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Feb 2009 (estimated)
- 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 is a study of the genetics of malaria transmission by the mosquito vector in Africa, Anopheles gambiae. The study focuses on the mosquito vector, not the human subjects infected with malaria. DNA extracted from infected mosquitoes will be analyzed genetically by microsatellite and single-nucleotide polymorphisms (SNPs) to identify mosquito genes that control mosquito resistance to malaria parasites.
Detailed description
A standard diagnostic blood smear from a drop of blood will be carried out on 20 study subjects once per month. One malaria-positive subject from among the 20 will be asked to donate 5cc of blood, also no more frequently than once per month. The blood will be placed in a water-jacketed heated membrane feeding device that will be positioned on top of a cage of mosquitoes. The mosquitoes are attracted to the warmth and drink the blood through the artificial skin-like membrane. The goal of the research is to study the infected mosquitoes. No studies will be carried out on the human subjects. The point of human subjects involvement is to obtain the naturally malaria-infected blood for feeding of mosquitoes. After blood feeding, the mosquitoes are held in an environmental chamber for one week, at which time they are dissected to count numbers of malaria parasites developing on the mosquito stomach wall. This number constitutes the quantitative phenotype, and we extract genomic DNA from the carcass for genetic marker typing, which constitutes the genotype. Genetic linkage analysis identifies markers near genes that control parasite number, thus resistance or susceptibility to parasite infection.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- community sample
Key inclusion criteria (1 listed)
- 5-10 years old, and general good health
Key exclusion criteria (3 listed)
- Outside age group
- Specific diagnosable health problems
- General poor health
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
mosquito infection
Time frame: one week
Protocol involves non-invasive blood draw from participant screened by finger-prick for infection with malaria. Drawn blood (0.5cc) is placed in artificial membrane feeder for feeding of mosquitoes. Primary outcome is infection of mosquitoes, detectable one week after blood feeding.
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 26 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Kenneth D Vernick, PhD principal investigator
University of Minnesota
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 Malaria, run by University of Minnesota at 1 site in United States.
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 3 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 26 Oct 2016. 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 United States. 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?
mosquito infection (time frame: one week). 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 26 Oct 2016.