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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00471666 |
Purpose
This study will examine the clinical, immunological and epidemiological effects of concurrent infections with P. falciparum and W. bancrofti or M.
perstans (the parasites that cause malaria and filariasis) on the frequency and severity of malaria infection in children and young adults in Mali, Africa.
Residents of Tien gu bougou and Bougoudiana, Mali, who are between 1 and 20 years of age may be eligible for this study. Participants with and without filarial infection will be enrolled.
Participants undergo the following tests and procedures:
| Condition |
|---|
|
Malaria Filariasis |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | Coinfection With Plasmodium Falciparum and Wuchereria Bancrofti: Clinical, Epidemiologic and Immunologic Implications |
| Estimated Enrollment: | 539 |
| Study Start Date: | May 2007 |
Residents of malaria-endemic regions are frequently exposed to a variety of other parasites concurrently with malarial parasites. In Mali, lymphatic filariasis due to Wuchereria bancrofti co-exists in several regions highly endemic for malaria, and co-infection is common in the residents of these areas. Because of the chronicity of filarial infections and an associated bias towards the development of an adaptive immune response dominated by Th2 cytokines, a pre-existing filarial infection has the potential to alter the immune response towards incoming malarial parasites, clearance of which are considered to be dependent on a robust Th1 response. This could, in turn, affect the clinical manifestations and outcomes of malaria infection.
Conversely, immune responses to filarial parasites may be modulated in the presence of malarial parasites. In addition to sharing a human host, Plasmodium falciparum and Wuchereria bancrofti are transmitted by the same mosquito vector, Anopheles gambiae, and interaction between the two species in the vector may have important implications for transmission of these two infections. The primary goals of this study are to determine the effect of concurrent infections with P. falciparum and W. bancrofti parasites on the prevalence and severity of malaria infection in children living in a Malian village co-endemic for two parasites and to assess the effects of co-infection on the immune responses to these two parasites over the course of the malaria transmission season. The epidemiology of co-infection at the human and vector level will also be examined.
Eligibility| Ages Eligible for Study: | 1 Year to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Age 1 - 20 years
Male or non-pregnant female
Resident of Tien gu bougou or Bougoudiana
EXCLUSION CRITERIA (Screening):
History or clinical evidence of severe and/or chronic illness
History of allergy to artesunate, amodiaquine, albendazole, praziquantel or mebendazole
Plans to relocate outside the immediate vicinity of the village during the study period
INCLUSION CRITERIA (Matched prospective study):
Age 1 - 20 years
Male or non-pregnant female
Resident of Tien gu bougou or Bougoudiana
EXCLUSION CRITERIA (Matched prospective study):
History or clinical evidence of severe and/or chronic illness
History of allergy to artesunate, amodiaquine, albendazole, praziquantel or mebendazole
Plans to relocate outside the immediate vicinity of the village during the study period
Hemoglobin less than or equal to 8 g/dL
Symptoms of malaria with parasitemia greater than or equal to 100,000/microliters at enrollment
Recent history or clinical evidence of prostration, bleeding, respiratory distress, seizures, coma or obtundation, jaundice, inability to drink, persistent vomiting
INCLUSION CRITERIA (Second transmission season)
Completion of matched prospective study during prior transmission season
EXCLUSION CRITERIA (Second transmission season)
History of clinical evidence of severe and/or chronic illness
History of allergy to artesunate, amodiaquine, albendazole, praziquantel or mebendazole
Plans to relocate outside the immediate vicinity of the village during the study period
Hemoglobin less than or equal to 8 g/dL
Recent history or clinical evidence of prostration, bleeding, respiratory distress, seizures, coma or obtundation, jaundice, inability to drink, persistent vomiting
Contacts and Locations More Information
| Study ID Numbers: | 999907148, 07-I-N148 |
| Study First Received: | May 9, 2007 |
| Last Updated: | March 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00471666 History of Changes |
| Health Authority: | United States: Federal Government |
|
Malaria Filariasis Coinfection Malaria Co-Infection |
|
Protozoan Infections Filariasis Parasitic Diseases |
Nematode Infections Malaria Helminthiasis |
|
Protozoan Infections Spirurida Infections Coccidiosis Filariasis Parasitic Diseases |
Nematode Infections Malaria Helminthiasis Secernentea Infections |
