Status:
COMPLETED
Malaria Studies in Cambodia
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Malaria
Eligibility:
All Genders
Up to 100 years
Brief Summary
This study, conducted by the National Center for Parasitology, Entomology and Malaria Control of Cambodia s Ministry of Health and the National Institute of Allergy and Infectious Diseases, will explo...
Detailed Description
Cohort study. Hemoglobin (Hb) and red blood cell (RBC) polymorphisms that give rise to HbE, alpha-thalassemia, G6PD-deficiency, and ABO blood groups occur at high frequency along the Thailand-Cambodia...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA: (Cohort Study)
- Resident of Kandal, Ekapheap, and Sangkumthmey villages (Thmar Da commune), and no plans to leave the Thmar Da commune for the next 5 years.
- Willingness to participate in the study as evidenced by informed consent of subjects or his/her parent or guardian, and willingness to come to commune health posts if he/she develops fever or other symptoms of malaria.
- Individuals of all ages will be enrolled.
- EXCLUSION CRITERIA: (Cohort Study)
- Any condition that in the opinion of the investigator would render the subject unable to comply with the protocol (e.g., psychiatric disease).
- Any health condition that in the opinion of the investigator would confound data analysis or pose unnecessary exposure risks to study personnel (e.g., individuals who are known to be HIV-infected or to have AIDS).
- INCLUSION CRITERIA: (P. vivax Collection Study)
- P. vivax malaria (mono-infection).
- Willingness to participate in the study as evidenced by informed consent of subjects or his/her parent or guardian.
- Age greater than or equal to 2.
- Hematocrit greater than or equal to 25%.
- EXCLUSION CRITERIA: (P. vivax Collection Study)
- Any condition that in the opinion of the investigator would render the subject unable to comply with the protocol (e.g., psychiatric disease).
- Any health condition that in the opinion of the investigator would confound data analysis or pose unnecessary exposure risks to study personnel (e.g., individuals who are known to be HIV-infected or to have AIDS).
- Pregnancy.
- Prior use of antimalarials during the past 2 months.
- INCLUSION CRITERIA: (Cord and Peripheral Blood Collection Study)
- Healthy male or female adults greater than or equal to 18 years old or healthy pregnant female adults greater than or equal to 18 years old.
- Willingness to participate in the study as evidenced by informed consent.
- EXCLUSION CRITERIA: (Cord and Peripheral Blood Collection Study)
- Any condition that in the opinion of the investigator would render the subject unable to comply with the protocol (e.g., psychiatric disease).
- Any health condition that in the opinion of the investigator would confound data analysis or pose unnecessary exposure risks to study personnel (e.g., individuals who are known to be HIV-infected or to have AIDS).
- INCLUSION CRITERIA: (Collection of peripheral blood for identifying and isolating memory B cells)
- Healthy male or non- pregnant female adults greater than or equal to 18 years old.
- Previous enrollment on the P. vivax collection study.
- Willingness to participate in the study as evidenced by written informed consent.
- EXCLUSION CRITERIA: (Collection of peripheral blood for identifying and isolating memory B cells)
- For the follow-up blood draw (250 mL), symptomatic parasitemia with any species of Plasmodium.
- For the follow-up blood draw (250 mL), hemoglobin level \<9 g/dL.
- For the follow-up blood draw (250 mL), weight \<45 kg.
- Any condition that in the opinion of the investigator would render the subject unable to comply with the protocol (e.g., psychiatric illness).
- Any health condition that in the opinion of the investigator would confound data analysis or pose unnecessary exposure risks to study personnel (e.g., individuals who are known to be HIV-infected or to have AIDS).
Exclusion
Key Trial Info
Start Date :
March 24 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 5 2013
Estimated Enrollment :
1978 Patients enrolled
Trial Details
Trial ID
NCT00663546
Start Date
March 24 2008
End Date
December 5 2013
Last Update
August 20 2018
Active Locations (3)
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1
National Center for Parasitology, Entomology, and Malaria Controk, Ministry of H
Phnom Penh, Cambodia
2
Preah Vihear Referral Hospital
Preah Vihear Province, Cambodia
3
Ratanakiri Referral Hospital
Ratanakiri Province, Cambodia