Plasmodium Falciparum MalariaNCT00322816
Malaria Prevalence in Children
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
The purpose of this pilot study is to evaluate the use of (1) 'malaria prevalence', (2) 'malaria incidence' and (3) 'malaria mortality' as a measure of malaria transmission in The Gambia, while mosquito insecticides (larvicides) are used to control malaria-carrying mosquitoes. Read more about this study
- Who is it for?
- Ages 6 months to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum Malaria
- How many people
- 2,552 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 6 months to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children living in the defined areas for intervention and between the age of 6 months and 10 years will be invited to participate. No distinctions will be made regarding gender or ethnic group. Moreover, as the target population is all people living in the areas of intervention, and in order of the results from this study to be as generalizable as possible, no distinctions will be made in terms of medical condition or physical health. Moreover, we believe that any children with a medical condition would be especially favored by the participation in the study.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Malaria Prevalence, Incidence and Mortality in Children
The purpose of this pilot study is to evaluate the use of (1) 'malaria prevalence', (2) 'malaria incidence' and (3) 'malaria mortality' as a measure of malaria transmission in The Gambia, while mosquito insecticides (larvicides) are used to control malaria-carrying mosquitoes. Two thousand children aged 6 months to 10 years of age will be recruited from villages in the study area. They will be monitored over 7 months for the presence of malaria parasites and signs and symptoms of the disease.
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. We plan 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. There are several steps which intervene between the survival of mosquito larvae in aquatic breeding sites and the human end points that we hope to achieve. 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. Once infected, the human population may either clear the infection over time or go on to develop symptoms. Among those who develop symptoms, some receive prompt and successful treatment, while some others go on to either develop chronic symptoms or to progress through severe malaria to death. Primary outcomes are: 1) the proportion of subjects with malaria parasites (Plasmodium Falciparum), 2) the incidence of clinical malaria, and 3) the age-standardized overall and malaria-specific mortality. Secondary outcomes are: 1) prevalence of a clinical episode of malaria (presence of malaria parasites plus an axillary temperature of 37.5 C or greater during examination or a history of fever during the last 48 hours); 2) prevalence of high parasitemias (defined as equal to of greater than 5000 parasites per mcl); 3) prevalence of enlarged spleen (defined using Hackett's classification); and 4) prevalence of severe anemia (defined as hemoglobin less than or equal to 5 g/dl). Within a broad area of eastern Gambia, zones have been identified for application of larvicide, with matched control zones where no larval control have been applied. In each area, the human population will be monitored to determine whether one of four specific malariometric end points will provide a valid assessment of larvicidal effectiveness. In this study 2000 children, 6 months to 10 years of age, will be recruited. These pilot studies will inform subsequent (not included in this NIH project) large scale evaluations of larviciding for malaria control. This protocol is designed to determine whether prevalence and incidence of malaria attacks and deaths can be used to evaluate the impact of Bti for malaria transmission control.
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- Malaria, Plasmodium falciparum, Gambia, larvicides
- 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
- 2,552 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322816
- Sponsor's protocol ID
- 05-0068
- 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
- Malaria Prevalence, Incidence and Mortality in Children
- ClinicalTrials.gov ID
- NCT00322816
- Acronym / sponsor ID
- 05-0068
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- Malaria, Plasmodium falciparum, Gambia, larvicides
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,552 participants (actual)
- 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.
The purpose of this pilot study is to evaluate the use of (1) 'malaria prevalence', (2) 'malaria incidence' and (3) 'malaria mortality' as a measure of malaria transmission in The Gambia, while mosquito insecticides (larvicides) are used to control malaria-carrying mosquitoes. Two thousand children aged 6 months to 10 years of age will be recruited from villages in the study area. They will be monitored over 7 months for the presence of malaria parasites and signs and symptoms of the disease.
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. We plan 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. There are several steps which intervene between the survival of mosquito larvae in aquatic breeding sites and the human end points that we hope to achieve. 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. Once infected, the human population may either clear the infection over time or go on to develop symptoms. Among those who develop symptoms, some receive prompt and successful treatment, while some others go on to either develop chronic symptoms or to progress through severe malaria to death. Primary outcomes are: 1) the proportion of subjects with malaria parasites (Plasmodium Falciparum), 2) the incidence of clinical malaria, and 3) the age-standardized overall and malaria-specific mortality. Secondary outcomes are: 1) prevalence of a clinical episode of malaria (presence of malaria parasites plus an axillary temperature of 37.5 C or greater during examination or a history of fever during the last 48 hours); 2) prevalence of high parasitemias (defined as equal to of greater than 5000 parasites per mcl); 3) prevalence of enlarged spleen (defined using Hackett's classification); and 4) prevalence of severe anemia (defined as hemoglobin less than or equal to 5 g/dl). Within a broad area of eastern Gambia, zones have been identified for application of larvicide, with matched control zones where no larval control have been applied. In each area, the human population will be monitored to determine whether one of four specific malariometric end points will provide a valid assessment of larvicidal effectiveness. In this study 2000 children, 6 months to 10 years of age, will be recruited. These pilot studies will inform subsequent (not included in this NIH project) large scale evaluations of larviciding for malaria control. This protocol is designed to determine whether prevalence and incidence of malaria attacks and deaths can be used to evaluate the impact of Bti for malaria transmission control.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children living in the defined areas for intervention and between the age of 6 months and 10 years will be invited to participate. No distinctions will be made regarding gender or ethnic group. Moreover, as the target population is all people living in the areas of intervention, and in order of the results from this study to be as generalizable as possible, no distinctions will be made in terms of medical condition or physical health. Moreover, we believe that any children with a medical condition would be especially favored by the participation in the study.
Key exclusion criteria (1 listed)
- None
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 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: 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.