- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00341666
Immune Response Regulation in People Infected Concurrently With Malarial and Filarial Parasites
Regulation of Innate and Adaptive Immune Responses in Individuals Infected Concurrently With Malarial and Filarial Parasites
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...
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Bamako, Mali
- University of Bamako, Faculty of Medicine, Pharmacy and Odontostomatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
Age 1-8 years or age 18-65 years.
Either resident of N'Tessoni (for active cohort) or resident of Bamako (for control cohort).
EXCLUSION CRITERIA:
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.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999906135
- 06-I-N135
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.
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