Severe Malaria and Anti-malarial Drug Resistance in Cambodia
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|ClinicalTrials.gov Identifier: NCT00341003|
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : July 2, 2017
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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.S. National Institutes of Health, will explore why some people with mild malaria progress to a severe form of the disease and why some malaria parasites are resistant to treatment.
Malaria is caused by a parasite that is transmitted to humans through a mosquito bite. It can cause fever, aches, and weakness. Left untreated, it can cause severe illness and even death. Malaria can be cured when it is treated with effective medicine, but some malaria parasites are resistant to medicine.
Children and adults with malaria symptoms and parasites in their blood will be recruited for this study from the Pursat Regional Health Center in Cambodia and the Thai-Cambodian border area within Pursat Province.
Participants are hospitalized for 4 to 6 days at the Pursat Regional Health Center. A small blood sample is collected for genetic study and to look for substances in the blood, such as certain proteins, that may help protect against severe malaria. Patients are then treated with two doses of Artequick(Registered Trademark) (artemisinin-piperaquine), the first dose upon arrival at the hospital and the second the next day. (Participants who are pregnant will be treated with either quinine or artesunate-mefloquine instead of Artequick.)
Patients undergo fingersticks several times during their hospital stay to collect a small drop of blood to monitor parasite counts. They are discharged from the hospital when their symptoms resolve and parasites can no longer be detected in their blood. After discharge, patients return to the clinic once a week for 3 weeks for a blood test to monitor for parasites, as some parasites may be slightly resistant to the medication. Patients in whom symptoms or parasites reappear undergo treatment with artesunate and mefloquine.
|Condition or disease|
|Severe Malaria Malaria Antimalarial Drug Resistance|
|Study Type :||Observational|
|Estimated Enrollment :||2090 participants|
|Official Title:||Multidisciplinary Studies of Severe Malaria and Antimalarial Drug Resistance in Cambodia|
|Study Start Date :||July 22, 2005|
|Study Completion Date :||January 14, 2011|
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00341003
|Pursat Regional Health Center|
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|First Posted:||June 21, 2006 Key Record Dates|
|Last Update Posted:||July 2, 2017|
|Last Verified:||January 14, 2011|
Vector Borne Diseases