P. Falciparum Malaria Clinical Trial
Official title:
Impact Tanzania in Vivo Efficacy 2010: Assessing the Efficacy of Artemisinin Combination Therapies for Treatment of Uncomplicated Malaria Infection in Children Aged 6-59 Months
Following the rapid development of significant drug resistance to both chloroquine and
sulfadoxine-pyrimethamine (the first line therapy in Tanzania from 2001 -2006), artemether-
lumefantrine (Coartem or AL) was adopted as first line therapy in Tanzania in 2006. Now that
this drug has been widely used for some time, the investigators propose to conduct an
antimalarial efficacy trial to monitor the effectiveness of this therapy, to determine if
this drug remains efficacious, or if significant resistance has emerged, in which case a new
antimalarial strategy will need to be contemplated. The investigators hypothesize that the
efficacy of Artemether-lumefantrine remains high, and that the other artemisinin combination
therapies will be equally efficacious.
Children 6-59 months of age with symptomatic malaria will be randomly assigned to be treated
with either artemether + lumefantrine (Coartem) or dihydroartemisinin-piperaquine
(Duo-Cotecxin or Artekin). Clinical, parasitologic, and hematologic parameters will be
monitored over a 42-day follow-up period and will be used to evaluate drug efficacy.
Status | Completed |
Enrollment | 323 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 59 Months |
Eligibility |
Inclusion Criteria: 1. Age 6-59 months 2. Axillary temperature = 37.5º C or history of fever in the past 48 hours 3. Weight = 5.0 kg 4. Slide-confirmed infection with P. falciparum, with parasitemia 2,000-200,000 asexual forms per µl 5. Live within the boundaries of the officially recognized catchment area of Miono Health Center. 6. Caregiver agrees to all blood draws and return visits. Exclusion Criteria: 1. General danger signs or symptoms of severe malaria 2. Signs or symptoms of severe malnutrition, defined as weight-for-age = 3 standard deviations below the mean (National Center for Health Statistics [NCHS]/World Health Organization [WHO] normalized reference values) 3. Slide confirmed infection with any other Plasmodium spp. besides falciparum or mixed plasmodium infection 4. Severe anemia, defined as Hb < 5 g/dl 5. Known hypersensitivity to any of the drugs being tested 6. Presence of febrile conditions caused by diseases other than malaria 7. Serious or chronic medical condition (heart failure, sickle cell disease). 8. Plan to travel or leave the area within the next 3 months. 9. Have been treated for malaria in the 2 weeks prior to enrollment. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Tanzania | Miono Health Center | Bagamoyo |
Lead Sponsor | Collaborator |
---|---|
Centers for Disease Control and Prevention |
Tanzania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 42-day polymerase chain reaction (PCR)-adjusted parasitological cure of P. falciparum parasitemia | 42 days | No | |
Secondary | Hematologic response to treatment measured as mean change in hemoglobin concentration from Day 0 to Day 42 | 42 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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