Immune Response Regulation in People Infected Concurrently With Malarial and Filarial Parasites

NCT00341666 | Completed

• 2 other identifiers: 99990613506-I-N135
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

This study, conducted by NIH and the University of Bamako in Mali, Africa, will study the effect of concurrent infections with malaria and filariasis on patients' immune response. Lymphatic filariasis is caused by infection with very small parasitic worms called Wuchereria bancrofti that are acquired from mosquitoes. The worms may cause no illness in many who are infected, but is some, they can cause swelling of the arms, legs, breast and genitalia, which may progress to permanent swelling referred to as elephantiasis. Malaria is caused by Plasmodium falciparum, another parasite that is spread by mosquitoes. It can cause fevers, headaches, body aches and weakness, and, if untreated, it can cause severe illness and death. The 8-month study will analyze measures of immune function in blood cells from people with or without filarial infections who become infected with malaria. The goal of the studies is to see if having a filarial worm infection affects immunity against malaria. Results of analysis of immune function in persons with malaria but without filaria infections will be compared with those harboring both filaria and malaria infections and also with results from healthy control subjects. Healthy individuals and patients with malaria and filarial infections between 1 and 8 years of age and between 18 to 65 years of age who live in N'Tessoni and healthy individuals living in Bamako, Mali (controls), may be eligible for this study. Participants have blood samples collected as follows during the study:

• A blood sample will be collected at the beginning of the study. Individuals found to have the filarial worm infection have a second sample drawn at nighttime when the filarial worms are present in the blood. Treatment for filaria infection will be offered to all infected individuals at the end of the study.
• A second sample will be collected during malaria season. Subjects will be interviewed about their health during the malaria season and re-tested for filarial and malaria infections with a finger-prick test. Those who test positive for malaria will be offered treatment to begin immediately after collection of the donated blood sample..
• A third sample will be collected after the end of the malaria season. Subjects will be interviewed again about their health and re-tested for filarial and malaria infections with a finger prick test. Those who have positive results for either infection will be offered treatment after collec...

Conditions

Malaria; Filarial Infection

Keywords

Immune Regulation; Co-Infection; Filariasis; Immunology; Filarial Infection

Eligibility Criteria

• Age: 1 Year - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 1-8 years or age 18-65 years.
• Either resident of N'Tessoni (for active cohort) or resident of Bamako (for control cohort).

You may not qualify if:

• Pregnancy (for the adult cohort).
• Hemoglobin less than or equal to 8g/dl.
• Symptoms of malaria with any level of parasitemia.
• Recent history or clinical evidence of prostration, bleeding, respiratory distress, seizures, coma or obtundation, jaundice, inability to drink, persistent vomiting.
• History of allergy to sulfa or pyrimethamine-sulfadoxine.
• Plans to relocate outside the immediate village vicinity during the study period.
• Clinical evidence of severe and/or chronic illness as determined by the examining physician.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

University of Bamako, Faculty of Medicine, Pharmacy and Odontostomatology

Bamako, Mali

Location

Related Publications (3)

• 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. doi: 10.4269/ajtmh.2001.64.iv. No abstract available.

  PMID: 11425185 BACKGROUND

• 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. doi: 10.1038/6560.

  PMID: 10086393 BACKGROUND

• World Health Organization. Sixth meeting of the Technical Advisory Group on the Global Elimination of Lymphatic Filariasis, Geneva, Switzerland, 20-23 September 2005. Wkly Epidemiol Rec. 2005 Nov 18;80(46):401-8. No abstract available. English, French.

  PMID: 16316047 BACKGROUND

MeSH Terms

Conditions

Malaria; Coinfection; Filariasis

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: April 3, 2006
• Study Completion: July 15, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-07-15

Locations

MA (1)