Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342043
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Examination of Protective Factors Against Severe Malaria
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Multidisciplinary Studies of Malaria Protection by Hemoglobinopathies and G6PD Deficiency in Mali
Status:
COMPLETED
Status Verified Date:
2009-04-16
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study sponsored by the National Institutes of Health and the University of Bamako in Mali Africa will examine factors that may protect against progression of malaria from mild to severe disease Infection with the malaria parasite causes disease ranging in severity from mild or no symptoms to severe A better understanding of what factors protect against disease progression may help scientists develop improved methods of disease prevention and treatment The objectives of this study are to
Identify differences in protective factors for severe malaria in Malinke children residing in two Mali villages Kela and Kangaba Genetic variations in hemoglobin proteins called HbS and HbC appear to confer protection against severe disease in some children but not others HbC appears to protect young Malinke children living in Kela but not in nearby Kangaba while HbS protects children in Kangaba but not in Kela In addition deficiency of an enzyme produced by red blood cells called G6PD protects males but not females from severe malaria
Investigate how fetal hemoglobin HbF may protect against malaria in infants and determine how HbS HbC G6PD deficiency and beta-thalassemia trait affect the rate of HbF decline during the first 2 years of life
Children under 11 years of age who seek medical care at Kangaba or Kela health centers for symptoms of malaria may be eligible for this study Each will be screened with a medical history physical examination and blood test In addition healthy infants born to women referred to field site clinics may be enrolled for the newborn study Participants undergo the following procedures
Children with mild malaria are treated with artesunate and amodiaquine Those with severe malaria are treated with quinine Blood is collected by finger prick every day for 4 days to evaluate the response to treatment and for genetic testing Some blood is stored for future research related to malaria
Newborns have a heel or finger prick at 1 3 and 6 months to collect a small blood sample for genetic testing In addition at the time of birth a small amount of blood is collected from one of the blood vessels of the placenta Some infants may be followed up to 2 years with additional drops of blood taken at 12 18 and 24 months Some of the blood is stored for future research related to malaria
Identify differences in protective factors for severe malaria in Malinke children residing in two Mali villages Kela and Kangaba Genetic variations in hemoglobin proteins called HbS and HbC appear to confer protection against severe disease in some children but not others HbC appears to protect young Malinke children living in Kela but not in nearby Kangaba while HbS protects children in Kangaba but not in Kela In addition deficiency of an enzyme produced by red blood cells called G6PD protects males but not females from severe malaria
Investigate how fetal hemoglobin HbF may protect against malaria in infants and determine how HbS HbC G6PD deficiency and beta-thalassemia trait affect the rate of HbF decline during the first 2 years of life
Children under 11 years of age who seek medical care at Kangaba or Kela health centers for symptoms of malaria may be eligible for this study Each will be screened with a medical history physical examination and blood test In addition healthy infants born to women referred to field site clinics may be enrolled for the newborn study Participants undergo the following procedures
Children with mild malaria are treated with artesunate and amodiaquine Those with severe malaria are treated with quinine Blood is collected by finger prick every day for 4 days to evaluate the response to treatment and for genetic testing Some blood is stored for future research related to malaria
Newborns have a heel or finger prick at 1 3 and 6 months to collect a small blood sample for genetic testing In addition at the time of birth a small amount of blood is collected from one of the blood vessels of the placenta Some infants may be followed up to 2 years with additional drops of blood taken at 12 18 and 24 months Some of the blood is stored for future research related to malaria
Detailed Description:
Our previous case-control study protocol 01-I-N020 established that hemoglobin Hb C protects against severe malaria in the Dogon ethnic group of Mali West Africa We believe that abnormal display of major parasite virulence antigens PfEMP-1 on the surface of HbC erythrocytes accounts for this protection Whether this mechanism mediates protection by other mutant erythrocytes remains to be investigated The principal objective of the current protocol has been to investigate whether HbC also protects against severe malaria in the Malinke of Kela which historically gave rise to the Dogon Our preliminary data from protocol 02-I-N285 suggest that HbC but not HbS sickle trait protects the young Malinke children of Kela with the opposite being true for the Malinke children of Kangaba a nearby village To confirm these novel preliminary findings and to investigate candidate mechanisms of protection our ongoing case-control study requires an additional 150 severe malaria patients who are less than 5 years old of Malinke ethnicity reside in either Kangaba or Kela villages and have normal G6PD activity Children less than 11 years old and diagnosed with either severe case or uncomplicated control malaria will be tested for hemoglobinopathies and G6PD deficiency Severe and uncomplicated malaria patients will be treated with parenteral quinine or oral artemisinin combination therapies respectively which are standard of care in Mali Principal outcome measures will include a comparison of the frequency of HbC HbS and G6PD deficiency between cases and controls with odds ratios and 95 confidence intervals determining the degree and statistical significance of severe malaria protection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-I-N214 | None | None | None |