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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

The Gambia1 site
  • Medical Research Council's Laboratories

    Fajara

Other trials in The Gambia

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.

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.

  1. First posted8 May 2006 (estimated)
  2. Study start7 Jun 2006
  3. Primary completion31 Mar 2008
  4. Study completion31 Mar 2009

Resources

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)
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

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.

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