Status:
COMPLETED
Malaria Transmission Studies in Mali
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Faculty of Science and Technology - FST
Conditions:
Malaria, Falciparum
Eligibility:
All Genders
6-65 years
Brief Summary
Background: \- Malaria is an illness caused by a parasite spread by mosquitoes. When a mosquito bites a person who is infected with a kind of parasite called a gametocyte, it is able to spread the in...
Detailed Description
Plasmodium falciparum malaria continues to evade control efforts in part through the complexity of its life cycle, which involves both humans and mosquitoes. While it is known that the gametocyte form...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA (COHORT STUDY)
- Age 6 months to 65 years, inclusive
- Resident of Kenieroba with no plans to relocate away from Kenieroba for 1 year
- Willingness to participate in the study as evidenced by informed consent (if \<18 years, the informed consent of parent or guardian of the child, and assent from children 14 to 17 years old)
- EXCLUSION CRITERIA (COHORT STUDY)
- Any condition that in the opinion of the investigator would render the participant 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 the participant (e.g., severe malnutrition)
- Pregnancy for venous blood collections (March 2013, October 2013, March 2014)
- INCLUSION CRITERIA (ADULT BLOOD COLLECTION STUDY)
- Age 18 to 65 years, inclusive
- Hb level greater than or equal to 8.5 g/dL
- Willingness to participate in the study as evidenced by informed consent
- EXCLUSION CRITERIA (ADULT BLOOD COLLECTION STUDY)
- Pregnancy
- Any condition that in the opinion of the investigator would render the participant 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 the participant (e.g., severe malnutrition)
- INCLUSION CRITERIA (PARASITIZED BLOOD COLLECTION STUDY):
- Age 2 to 17 years, inclusive
- Hb level greater than or equal to 8.5 g/dL
- Previous enrollment in cohort study on protocol #08-I-N120
- Uncomplicated malaria\*
- P. falciparum density greater than or equal to 10,000/microliters
- Known hemoglobin type HbAA or HbAS
- Not enrolled in this protocol s cohort study
- Willingness to participate in the study as evidenced by informed consent and assent from children 14-17 years old)
- Uncomplicated malaria: axillary temperature \>37.5 degrees Celcius or history of fever in the past few days and no criteria of SM (see next paragraph) and no other etiologies of febrile illness (e.g., respiratory tract infection) on clinical examination.
- Severe P. falciparum malaria: parasitemia of any density and any one of the following: coma
- (Blantyre coma score less than or equal to 2), convulsions (witnessed by investigator), severe prostration, severe anemia (hemoglobin less than or equal to 6 g/dl), respiratory distress, hypoglycemia (serum glucose less than or equal to less than or equal to 40 mg/dl), jaundice/icterus, shock (systolic blood pressure less than or equal to 70 mmHg, rapid pulse, cool extremities), cessation of eating and drinking, repetitive vomiting.
- EXCLUSION CRITERIA (PARASITIZED BLOOD COLLECTION STUDY):
- Pregnancy
- Any condition that in the opinion of the investigator would render the participant 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 risks to study participants (e.g., severe malnutrition, acquired or inherited immunodeficiency)
Exclusion
Key Trial Info
Start Date :
March 20 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 20 2015
Estimated Enrollment :
534 Patients enrolled
Trial Details
Trial ID
NCT01829737
Start Date
March 20 2013
End Date
January 20 2015
Last Update
August 2 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892