Status:
COMPLETED
Examination of Protective Factors Against Severe Malaria
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Malaria
Severe Malaria
Eligibility:
All Genders
Up to 10 years
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 diseas...
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 displa...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- All malaria patients enrolled in the case-control study will be less than 11 years old.
- Uncomplicated malaria: Axillary temperature greater than 37.5 degrees Celsius or history of fever, signs and symptoms of malaria (e.g. headache, body aches, malaise), asexual parasite density less than 500,000 per microliter of blood, no criteria of severe malaria (see next paragraph), and no other etiologies of febrile illness (e.g. respiratory tract infection, cellulitis) on clinical examination.
- Severe malaria: Asexual parasite density greater than or equal to 100,000/uL or parasitemia of any density plus any one of the following: coma (defined as Blantyre coma score less than or equal to 2), convulsions (witnessed by investigator), severe prostration, severe anemia (hemoglobin less than 5 g/dL), respiratory distress, hypoglycemia (serum glucose less than 40 mg/dL), jaundice/icterus, shock (systolic blood pressure less than 50 mmHg, rapid pulse, cool extremities), cessation of eating and drinking, repetitive vomiting.
- EXCLUSION CRITERIA:
- Patients who are parasitemic yet are found by clinical examination to have another etiology of febrile illness (e.g., respiratory tract infection, cellulitis) will not be formally enrolled into the protocol, but may be treated for both malaria and their coexisting infection by the study team.
Exclusion
Key Trial Info
Start Date :
August 2 2005
Trial Type :
OBSERVATIONAL
End Date :
April 16 2009
Estimated Enrollment :
4850 Patients enrolled
Trial Details
Trial ID
NCT00342043
Start Date
August 2 2005
End Date
April 16 2009
Last Update
July 2 2017
Active Locations (1)
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1
Malaria Research and Training Center
Bamako, Mali