Malaria
Conditions
Interventions
Part 1 Control Group
Part 1 Intervention group
Part 2 Control group
Part 2 Intervention group I
Part 2 Intervention group
Part 3 Control group
Part 3 control group
Sponsors
Purdue university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For Part 1 and 2 of the study, all individuals must meet all the inclusion criteria below: a. Patients diagnosed with symptomatic mild to moderate P. falciparum malaria with a parasite density of >= 5000 parasites/µl b. Adult male, age 18-55 years old or Adult female, age 18-55 years that are post-menopausal, actively on birth control, or test negative on a pregnancy test. c. Provision of informed consent and agrees to hospital admission for at least 1-2 days d. Good health condition other than malaria e. The patient has not taken anti-malarial drugs in the past 4 weeks For Part 3 of the trial, all individuals must meet all the inclusion criteria below: a. Patients diagnosed with symptomatic mild to moderate P. falciparum malaria and a parasite density of >= 5000 parasites/µl b. Age 12 months to below 18 years c. In the case of post pubertal females, only non-pregnant (either actively on birth control and/or test negative on a pregnancy test) d. Presented by parent or legally accepted representative (LAR) who has consented to the participation of the child in the trial e. Hb levels > 5mg/dL f. Child has not taken anti-malarial drugs in the past 6 weeks.
Exclusion criteria
Exclusion criteria: a) unable to provide informed consent b) symptoms and signs of severe or complicated malaria c) parasite density > 200,000 parasites /µl d) other neurological or psychiatric symptoms or disorders e) abnormal bleeding f) resting heart rate lower than 55 or higher than 100 bpm g) history of cardiac disease h) signs, symptoms and laboratory results of impairment of vital organs such as liver, lungs, kidney and cardiovascular system i) Abnormal blood blood counts/chemistry including, liver function tests j) symptoms and signs of infection such as pneumonia, dengue fever, and other viral or bacterial infection. k) patients with symptoms of gastrointestinal infections or any sign of malabsorption that may interfere with drug absorption. l) concomitant infection by plasmodium species other than P. falciparum m) inability to attend/meet study staff on follow up visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine if the triple combination AL+IM (ALIM) exhibits non-inferior safety and tolerability as compared to the SOC (AL) alone in adults, and all age groups above 12 months - evaluated by the number and severity of adverse events of AL+IM when compared to AL alone;To determine if the addition of IM to AL allows for the complete clearance of P. falciparum after only 2 days of dosing in adults and pediatric age groups above 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine if there is accelerated parasite clearance of AL+IM compared to patients receiving the AL | — |
Countries
Kenya
Contacts
Public ContactQuentin Awori
Senior Research Scientist
Outcome results
None listed