Plasmodium Falciparum MalariaNCT00322738
Time to Infection With Malaria Parasites
An observational study of Plasmodium Falciparum Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in The Gambia.
Trial summary
This study will attempt to find out what effect mosquito insecticides have on the transmission of malaria in The Gambia. Eight hundred healthy men and women, aged 18 to 40 years, living in selected villages east of Farafenni town in The Gambia, West Africa will be screened for parasites. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum Malaria
- How many people
- 2,558 participants
- Where
- 1 siteThe Gambia
- Study dates
- 7 Jun 2006to 31 Mar 2009
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults living in the selected villages who consent to join the study,
- between the ages of 18 to 40 years old, and
- free of clinical signs or symptoms of illness at recruitment.
Who cannot join
- Adults who do not consent to join the study,
- sick men and women (i.e., have clinical signs or symptoms of illness),
- men and women 41 years or older, or
- children.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time to Infection With Malaria Parasites in Adults
This study will attempt to find out what effect mosquito insecticides have on the transmission of malaria in The Gambia. Eight hundred healthy men and women, aged 18 to 40 years, living in selected villages east of Farafenni town in The Gambia, West Africa will be screened for parasites. About 552 of these people are expected to be free of malaria and will form the study group. These people will participate in the study for 7 months and will be checked for the malaria-causing parasite every two weeks by finger prick blood sample.
Read the detailed description
Malaria remains one of the world's greatest childhood killers and is a substantial obstacle to social and economic development in the tropics. The overwhelming bulk of the world's malaria burden rests upon the population of sub-Saharan Africa because of the unique coincidence of expanding human populations, weak health systems, the world's most effective vector mosquito species and environmental conditions ideal for transmission. At the start of the new millennium malaria is still deeply entrenched in Africa and effective malaria control is under threat from the inexorable spread of parasite strains resistant to antimalarial drugs and the emergence of mosquitoes resistant to the pyrethroid insecticides used to impregnate bednets. Larval control may offer a new alternative for effective control. Mosquito larval control strategies (environmental management and larviciding) have historically been shown to be successful in reducing the abundance of mosquitoes. This study plans to apply a larvicide in an effort to control malaria and reduce the burden of malaria. While it is abundantly clear that this product will kill mosquito larvae in the laboratory and in the field, it is not certain that doing so will reduce the burden of malaria for the human population. Briefly, the steps involved include survival and development of immature mosquito stages, emergence of adult mosquitoes, blood feeding by those mosquitoes, acquisition and development of malaria parasites by adult mosquitoes and transmission of parasites to susceptible humans. The objective of this pilot study is to evaluate the use of the time-to-infection end point as a measure of malaria transmission in The Gambia, while mosquito larvicides are used to control malaria vectors. The main outcomes of this study are (1) the proportion of adults with detectable parasitemia (Plasmodium falciparum) that is a binary variable and (2) time-to-infection with malaria parasites that will be treated as a continuous variable. This experimental design takes place over 7 months. The target sample size is 800 adults (aged 18-40 years, approximately half will be women and half men) living in 50 villages east of Farafenni town in The Gambia, West Africa. It is estimated that 552 of the adults will have no detectable parasites in their blood at the beginning of the transmission season (June). These parasite negative individuals will be followed either for the duration of the transmission season (June through November) or until they become positive for parasites.
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- malaria, Plasmodium falciparum, Gambia, larvicides, vector
- Medical subject headings
- Malaria, Falciparum, Malaria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2006 (estimated)
- Study start7 Jun 2006
- Primary completion31 Mar 2008
- Study completion31 Mar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium Falciparum MalariaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 2,558 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322738
- Sponsor's protocol ID
- 05-0067
- Status last verified
- Nov 2011
- First submitted
- 4 May 2006
- Last updated
- 1 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Infection With Malaria Parasites in Adults
- ClinicalTrials.gov ID
- NCT00322738
- Acronym / sponsor ID
- 05-0067
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- malaria, Plasmodium falciparum, Gambia, larvicides, vector
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,558 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 7 Jun 2006
- Primary completion
- 31 Mar 2008 (actual)
- Study completion
- 31 Mar 2009 (actual)
- First posted
- 8 May 2006 (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 study will attempt to find out what effect mosquito insecticides have on the transmission of malaria in The Gambia. Eight hundred healthy men and women, aged 18 to 40 years, living in selected villages east of Farafenni town in The Gambia, West Africa will be screened for parasites. About 552 of these people are expected to be free of malaria and will form the study group. These people will participate in the study for 7 months and will be checked for the malaria-causing parasite every two weeks by finger prick blood sample.
Detailed description
Malaria remains one of the world's greatest childhood killers and is a substantial obstacle to social and economic development in the tropics. The overwhelming bulk of the world's malaria burden rests upon the population of sub-Saharan Africa because of the unique coincidence of expanding human populations, weak health systems, the world's most effective vector mosquito species and environmental conditions ideal for transmission. At the start of the new millennium malaria is still deeply entrenched in Africa and effective malaria control is under threat from the inexorable spread of parasite strains resistant to antimalarial drugs and the emergence of mosquitoes resistant to the pyrethroid insecticides used to impregnate bednets. Larval control may offer a new alternative for effective control. Mosquito larval control strategies (environmental management and larviciding) have historically been shown to be successful in reducing the abundance of mosquitoes. This study plans to apply a larvicide in an effort to control malaria and reduce the burden of malaria. While it is abundantly clear that this product will kill mosquito larvae in the laboratory and in the field, it is not certain that doing so will reduce the burden of malaria for the human population. Briefly, the steps involved include survival and development of immature mosquito stages, emergence of adult mosquitoes, blood feeding by those mosquitoes, acquisition and development of malaria parasites by adult mosquitoes and transmission of parasites to susceptible humans. The objective of this pilot study is to evaluate the use of the time-to-infection end point as a measure of malaria transmission in The Gambia, while mosquito larvicides are used to control malaria vectors. The main outcomes of this study are (1) the proportion of adults with detectable parasitemia (Plasmodium falciparum) that is a binary variable and (2) time-to-infection with malaria parasites that will be treated as a continuous variable. This experimental design takes place over 7 months. The target sample size is 800 adults (aged 18-40 years, approximately half will be women and half men) living in 50 villages east of Farafenni town in The Gambia, West Africa. It is estimated that 552 of the adults will have no detectable parasites in their blood at the beginning of the transmission season (June). These parasite negative individuals will be followed either for the duration of the transmission season (June through November) or until they become positive for parasites.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults living in the selected villages who consent to join the study,
- between the ages of 18 to 40 years old, and
- free of clinical signs or symptoms of illness at recruitment.
Key exclusion criteria (4 listed)
- Adults who do not consent to join the study,
- sick men and women (i.e., have clinical signs or symptoms of illness),
- men and women 41 years or older, or
- children.
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
Not reported in the source record.
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 Feb 2019.
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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 Plasmodium Falciparum Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in The Gambia.
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 3 inclusion and 4 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 Feb 2019. 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 The Gambia. 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.
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 Feb 2019.