NCT00368810

Completed

Study of Factors Involved in Resistance to Severe Malaria

National Institute of Allergy and Infectious Diseases (NIAID)Source

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Other study identifiers

Sponsor study identifier

999906104

Secondary identifiers

06-I-N104

Study Type

observational

Reported enrollment (type unavailable)

120

Locations

1 country

Sites

1

Timeline

Study Start

February 21, 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

November 30, 2006

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

This study will examine whether resistance to severe malaria is associated with weakening of a specific immune response (TLR-mediated pro-inflammatory cytokine response). Some children with mild malaria go on to develop severe disease, while others do not. The study will analyze certain substances in the blood to try to determine what factors may protect against severe malaria. Healthy children and children 3 - 10 years of age with severe malaria who are being treated at l'H pital Gabriel Toure in Mamako, Mali, West Africa, may be eligible for this study. Participants have a mall sample of blood drawn from a vein and from two finger pricks.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 120 participants
Study completion date: November 30, 2006
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 21, 2006
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
August 22, 2006
Actual (reported)
First Posted
August 25, 2006
Actual (reported)
Study Completion
November 30, 2006
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: July 2, 2017
Status Verified: November 30, 2006
Last Update Submitted: June 30, 2017

Conditions

Malaria

Keywords

ChildrenCross-SectionalGlycosylphosphatidylinositolCytokinesPeripheral Blood Mononuclear CellsMalaria

Eligibility Criteria

Age2 Years - 10 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

Males or females ages 3 to 10.
Severe malaria as defined by positive blood smear for P. falciparum and need for hospitalization in accordance with the WHO definition of severe malaria (group I), or mild malaria as defined by positive blood smear for P. falciparum and triage to outpatient treatment (group II).
Willingness of parent or guardian to have his or her child participate in the study as evidenced by the completed informed consent document.
Males or females ages 3 to 10.
No clinical evidence of malaria and negative blood smear.

Sponsors & Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
NIHlead

Study Sites (1)

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, 20892, United States

Related Publications (1)

Boutlis CS, Gowda DC, Naik RS, Maguire GP, Mgone CS, Bockarie MJ, Lagog M, Ibam E, Lorry K, Anstey NM. Antibodies to Plasmodium falciparum glycosylphosphatidylinositols: inverse association with tolerance of parasitemia in Papua New Guinean children and adults. Infect Immun. 2002 Sep;70(9):5052-7. doi: 10.1128/IAI.70.9.5052-5057.2002.
PMID: 12183552BACKGROUND

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Design

Study Type: observational
Sponsor Type: NIH

Study Record Dates

First Submitted

August 22, 2006

First Posted

August 25, 2006

Study Start

February 21, 2006

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

November 30, 2006

Date type not reported

This date has not been verified as actual or estimated.

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No acute febrile or systemic illness.

Willingness of parent or guardian to have his or her child participate in the study as evidenced by the completed informed consent document.

You may not qualify if:

Active bleeding or hematocrit less than or equal to 15%.
Participation in a vaccine or drug trial within 30 days of starting this study.
Use of corticosteroids or immunosuppressive drugs within 30 days of starting this study.
Receipt of a live vaccine within past 4 weeks or killed vaccine within past 2 weeks prior to entry into the study.
Known history of HIV infection.
Positive malaria smear.
Sibling of malaria patient.
Active bleeding or hematocrit less than or equal to 15%.
Participation in a vaccine or drug trial within 30 days of starting this study.
Use of corticosteroids or immunosuppressive drugs within 30 days of starting this study.
Receipt of a live vaccine within past 4 weeks or killed vaccine within past 2 weeks prior to entry into the study.
Known history of HIV infection.

Contact the study team to confirm eligibility.

Last Updated

July 2, 2017

Record last verified: 2006-11-30

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT00368810
Data provider: ClinicalTrials.gov
Source updated: 2017-07-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:12 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations