Medical Implications of Coinfection With Malaria and Filariasis Parasites

June 30, 2017 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Coinfection With Plasmodium Falciparum and Wuchereria Bancrofti: Clinical, Epidemiologic and Immunologic Implications

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.

Study Overview

Status

Completed

Conditions

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

Observational

Enrollment (Anticipated)

1039

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mali
      • Bamako, Mali
        • Faculty of Medicine, Pharmacy and Odonto-Stomatology (FMPOS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 7, 2007

Study Completion

January 31, 2012

Study Registration Dates

First Submitted

May 9, 2007

First Submitted That Met QC Criteria

May 9, 2007

First Posted (Estimate)

May 10, 2007

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

January 31, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999907148
  • 07-I-N148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malaria

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe