Medical Implications of Coinfection With Malaria and Filariasis Parasites

This study has been completed.

Sponsor:

Information provided by:

National Institutes of Health Clinical Center (CC)

ClinicalTrials.gov Identifier:

NCT00471666

First received: May 9, 2007

Last updated: February 1, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	May 9, 2007
Last Updated Date	February 1, 2012
Start Date ^ICMJE	May 2007
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00471666 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Medical Implications of Coinfection With Malaria and Filariasis Parasites
Official Title ^ICMJE	Coinfection With Plasmodium Falciparum and Wuchereria Bancrofti: Clinical, Epidemiologic and Immunologic Implications
Brief Summary	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: Baseline evaluation with medical history and physical examination, blood tests and stool culture Brief physical examinations weekly Blood tests monthly for malaria Standard treatment offered for anyone with malaria Blood tests for filarial infection at the beginning, midpoint and end of the transmission season Treatment for lymphatic filariasis is available through the National Program for the Elimination of Lymphatic Filariasis. There is no effective standard therapy for M. perstans. Treatment for other parasitic worm infections, if needed.
Detailed Description	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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition ^ICMJE	Malaria Filariasis
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Marsh K, Kinyanjui S. Immune effector mechanisms in malaria. Parasite Immunol. 2006 Jan-Feb;28(1-2):51-60. Review. Breman JG, Egan A, Keusch GT. The intolerable burden of malaria: a new look at the numbers. Am J Trop Med Hyg. 2001 Jan-Feb;64(1-2 Suppl):iv-vii. No abstract available. Gupta S, Snow RW, Donnelly CA, Marsh K, Newbold C. Immunity to non-cerebral severe malaria is acquired after one or two infections. Nat Med. 1999 Mar;5(3):340-3.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	1039
Completion Date	January 2012
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	INCLUSION CRITERIA (Screening): 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: (Immunologic Extension Study) Age > 10 years Male or non-pregnant female (by history) Resident of Tien gu bougou or Bougoudiana Willingness to allow storage of specimens for future research EXCLUSION CRITERIA: (Immunologic Extension Study) History or clinical evidence of severe and/or chronic illness Hemoglobin less than or equal to g/dL Positive pregnancy test Clinical malaria (symptoms of malaria plus any malaria parasites identified on thick smear)
Gender	Both
Ages	1 Year to 20 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Mali

Administrative Information
NCT Number ^ICMJE	NCT00471666
Other Study ID Numbers ^ICMJE	999907148, 07-I-N148
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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