Status:
COMPLETED
Severe Malaria and Anti-malarial Drug Resistance in Cambodia
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Severe Malaria
Malaria
Eligibility:
All Genders
Brief Summary
This study, conducted by the National Center for Malaria Control of Cambodia's Ministry of Health, the Guangzhou University of Traditional Chinese Medicine in the People's Republic of China, and the U...
Detailed Description
Hemoglobin E (HbE) is distinguished from normal HbA by a single amino acid mutation (beta26: Glu to Lys). High allele frequencies in some areas of Cambodia are believed to have been naturally selected...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Uncompleted malaria: Age greater than 10 years axillary, temperature greater than 37.5 degrees Celsius or history of fever, signs and symptoms of malaria (e.g. headache, body aches, malaise), asexual parasitemia greater than or equal to 10000/ul, NO criteria of severe malaria and NO other etiologies of febrile illness (e.g., respiratory tract infection) on clinical examination, and NO history of antimalarial drug use for present symptoms.
- Severe malaria: Age greater than or equal to 10 years, asexual parasitemia greater than or equal to 10000/uL, NO history of antimalarial drug use for present symptoms, and any one of the following: coma (defined as Glasgow coma score less than or equal to 9 in adults, or Blantyre coma score less than or equal to 2 in children), convulsions (witnessed), prostration, severe anemia (hemoglobin less than 5 g/dL), respiratory distress, hypoglycemia (serum glucose less than 40 mg/dL), jaundice/icetrus, renal insufficiency (anuria for 24 hours or more), hemoglobinuria, state of shock (systolic blood pressure less than 50 mmHg, rapid pulse, cool extremities), cessation of eating and drinking, repetitive vomiting.
- EXCLUSION CRITERIA:
- Individuals who live in malaria endemic areas and are asymptomatic or have anon-malaria illness can sometimes be incidentally noted to be parasitemic, patients who are parasitemic yet are found by clinical examination to have another etiology of febrile illness (e.g. respiratory tract infection) will be excluded from the protocol, but will be treated by the Cambodian Ministry of Health staff for both malaria and their coexisting infection. Pregnant women will also be excluded from this protocol but will be treated by study physicians with guinine (first trimester) or artemisinin-mefloquine (second or third trimester).
Exclusion
Key Trial Info
Start Date :
July 22 2005
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 14 2011
Estimated Enrollment :
2090 Patients enrolled
Trial Details
Trial ID
NCT00341003
Start Date
July 22 2005
End Date
January 14 2011
Last Update
July 2 2017
Active Locations (1)
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1
Pursat Regional Health Center
Pursat, Cambodia