A Phase 3 interventional study of Amodiaquine + Artesunate and Amodiaquine + Artesunate in Malaria, sponsored by University of Lagos, Nigeria. Completed at 2 sites in Nigeria. Open to participants aged 6 Months to 5 Years. Per ClinicalTrials.gov, last updated 2012-05-31.
Sponsored by University of Lagos, Nigeria · Phase 3, Interventional, and Treatment
In the last decade, the prevalence of malaria has been escalating at an alarming rate, especially in Africa. An estimated 300 to 500 million cases each year cause 1.5 to 2.7 million deaths, more than 90% occur in children under 5 years of age in Africa (WHO 1995). Malaria is Africa's leading cause of under-five mortality (20%) and constitutes 10% of the continent's overall disease burden. It accounts for 40% of public health expenditure, 30-50% of inpatient admissions, and up to 50% of outpatient visits in areas with high malaria transmission. Antioxidant micronutrients have immunomodulatory role and may have suppressive activity.
The pathogenesis of plasmodial infection hinges on intracellular invasion of host erythrocyte and hepatocyte with possible generation of free radicals that may contribute to cellular membrane damage. This will make uninfected erythrocyte and hepatocyte to be more susceptible to merozoite invasion. Zinc and Selenium has immunomodulatory properties. They enhance cell-mediated immune response in malaria infection. This may help to adequately suppress schizont maturation and inhibit the release of merozoites. However, it is possible that they have a direct chemosuppressive or blood schizonticidal effect. The following research questions emanated from this hypothesis;
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 10 is below the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →University of Lagos, Nigeria is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
adequate antimalarial treatment within the previous 7 days
Amodiaquine will be administered orally at 10mg/kg daily for 3days. Artesunate 50mg will be administered orally daily for 3days.For subjects \>6months\< 1 years 4mg/kg daily for 3 days
Drug: Amodiaquine + Artesunate
Artemether 20mg/Lumefantrine 120mg fixed combination administered daily for 3 days
Drug: Lumefantrine + Artemether
Artesunate 50mg daily for 4days. if \>6 months\< 1 year 4mg/kg daily for 4days + Vitamin A 5000IU daily for 4days if \< 1 year and 10,000IU daily for 4days if \> 1 year respectively
Dietary Supplement: Artesunate + vitamin A
Artesunate 50mg daily for 4 days.if \>6 months\< 1 year 4mg/kg daily for 4 days + vitamin E 100mg daily administered orally to the experimental group 4 days.
Dietary Supplement: Artesunate + vitamin E
cohort E will be given Artesunate 50mg daily for 4 days. if \> 6 months\< 1 year 4mg/kg daily for 4 days + zinc gluconate 50mg orally daily for 4 days. if \< 1 year 25 mg daily for 4 days
Dietary Supplement: Artesunate + Zinc
Artesunate 50mg daily for 4 days. if \> 6 months\< 1 year 4mg/kg daily for 4 days + selenium 100ug daily for 4 days. if \< 1 year 50ug daily for 4 days.
Dietary Supplement: Artesunate + selenium
Amodiaquine 10mg/kg daily for 3 days + vitamin A 5000iu daily for 4 days if \< 1 year. 10,000 IU daily for 4 days if \> 1 year.
Dietary Supplement: Amodiaquine + vitamin A
Amodiaquine 10mg/kg daily for 4 days + vitamin E 100 mg daily for 4 days
Dietary Supplement: Amodiaquine + Vitamin E
Amodiaquine 10mg/kg daily for 4 days + zinc 50mg daily 4 days. if \< 1 year 25 mg daily for 4 days.
Dietary Supplement: Amodiaquine + Zinc
Amodiaquine 10mg/kg daily for 4 days + selenium 100ug daily for 4 days if \> 1 year. 50ug daily for 4 days if \< 1 year.
Dietary Supplement: Amodiaquine + Selenium
Tab Artesunate 50mg orally dly x 4 days + Vitamin A, 5000IU orally, dly x 4 days if ≤ 1yr. 10,000IU orally dly x 4days if \> 1 yr + vitamin E 100 mg orally dly for 4 days
Dietary Supplement: Artesunate + vitamin A + vitamin E
Tab Artesunate 50 mg daily for 4 days. Vitamin A 5OOOIU daily for 4 days if \< 1 year. 10,000IU daily for 4 days if \> 1 year. All administered orally.
Dietary Supplement: Artesunate + Vitamin A + Zinc
Artesunate 50 mg orally, daily for 4 days. Vitamin A 5000IU orally daily for 4 days if \< 1 year. 10,000IU orally daily for 4 days if \> 1 year.
Dietary Supplement: Artesunate + Vitamin A + Selenium
Artesunate 50mg daily for 4 days. vitamin E 100mg daily for 4 days. Zinc 50 mg daily for 4 days if \> 1 year. 25 mg daily for 4 days if \< 1 year.
Dietary Supplement: Artesunate + Vitamin E + Zinc
Tab Artesunate 50 mg orally daily for 4 days. Vitamin E 100 mg orally daily for 4 days. Tab selenium 100 ug orally daily for 4 days if \> 1 year. 50 ug orally daily for 4 days if \< 1 year.
Dietary Supplement: Artesunate + Vitamin E + Selenium
Intervention:the intervention in this group involves the use of standard antimalarial therapy for uncomplicated malaria based on WHO recommendation. artemisin based combination therapy will be used. amodiaquine will be administered via the oral route at a dose of 10mg/kg daily while artesunate will be administered orally at Artesunate 100mg stat, 50mg 8hrs later and 50mg bd x 3days
Intervention:the intervention in this group involves the use of standard antimalarial therapy for uncomplicated malaria based on WHO recommendation. artemisinin based combination therapy will be used. amodiaquine will be administered via the oral route at a dose of 10mg/kg daily while artesunate will be administered orally at 100mg stat, 5omg 8hrs later and 50mg 12hrly for 3 days
Lumefantrine and artemether combination will be administered orally at a dose of 120/20mg daily for 3days
Artesunate will be administered orally at a dose of 100mg stat then 50 mg 8hrs later and 50mg 12hrly for 3days. vitamin A will be administered orally at a dose of 2000IU daily for 3 days
Artesunate will be administered orally at 100mg stat, then 50mg 8hrs after and 50mg 12hrly for 3 days. Vitamin E will be administered orally at 100mg dly for 3 days.
Artesunate will be administered orally at a dose of 100mg stat then 50mg 8hrs after and 50mg 12mg 12hrly for 3 days. Zinc gluconate will be administered orally at a dose of 50mg dly for 4 days
Artesunate will be administered orally at 100mg stat and 8hrs later 50mg. then 50mg 12hrly for 3 days. selenium will be administered orally at a dose of 100ug dly for 4 days
Amodiaquine will be administered orally at a dose of 10mg/kg dly for 3days. Vitamin A will be administered orally dly at a dose of 2000IU for 4 days
Amodiaquine will be administered orally at a dose of 10mg/kg dly for 3days. vitamin E will be administered orally at a dose 100mg daily for 4 days
Amodiaquine will be administered orally at a dose of 10mg/kg dly for 3days. Zinc gluconate will be administered orally at a dose of 50mg dly for 4 days.
Amodiaquine will be administered orally at a dose of 10mg/kg daily for 3days. Selenium will be administered orally at a dose of 100ug daily for 4 days if \> 1year. 50ug daily for 4 days if \< 1 year.
Tab Artesunate 50mg orally daily for 4 days. Vitamin A, 5000IU orally daily for 4days if \< 1 year. 10,000 IU orally daily for 4 days if \> 1 year.
Tab Artesunate 50 mg daily for 4 days. Vitamin A 5OOOIU daily for 4 days if \< 1 year. 10,000IU daily for 4 days if \> 1 year. All administered orally.
Tab Artesunate 50 mg orally, daily for 4 days. Vitamin A 5000IU orally daily for 4 days if \< 1 year. 10,000IU orally daily for 4 days if \> 1 year.
Tab Artesunate 50 mg orally daily for 4 days. Vitamin E 100 mg orally daily for 4 days. Tab selenium 100 ug orally daily for 4 days if \> 1 year. 50 ug orally daily for 4 days if \< 1 year.
Tab Artesunate administered orally at 50 mg daily for 4 days. Vitamin E 100 mg orally daily for 4 days. Tab Zinc 50 mg orally daily for 4 days if \< 1 year. 25 mg orally daily for 4 days if \> 1 year.
7-day cure rate
7-day Cure rate will be defined as initial and sustained parasite and symptom clearance with no increase in asexual parasitemia 48 h after the initiation of treatment and the absence of microscopically detected asexual parasitemia within 120 h of the commencement of treatment until day 7
Time frame: 4 weeks
28-day cure rate.
the number of patients with clinical and parasitological cure by day 28 divided by the total number of patients who could be evaluated (per protocol population).
Time frame: 4 weeks
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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University of Lagos, Nigeria