Health Condition 1: null- Children and adolescent patietns with uncomplicated Plasmodium falciparum malaria
Conditions
Interventions
Intervention1: Dihydroartemisinin and piperaquine: The two strengths of Eurartesim® film coated formulation, used for this study are the following
160 & 20 mg Piperaquine Tetraphosphate & Dihydroart
Sponsors
Medicines for Malaria Venture
Eligibility
Inclusion criteria
Inclusion criteria: Male and Female paediatric patients aged from 6 months to less than 18 years Ability to swallow oral tablets as whole or crushed tablets Body weight more than and equal to 5 kg and less 100 kg Acute uncomplicated malaria, with microscopically confirmed mono-infection by P. falciparum parasitaemia comprised between 80 and less than 100000 parasites per micro liter of blood History of fever anytime during the preceding 24 hours or presence of fever axillary temperature more than 37.5 degree centigrate Ability of parents or legally acceptable representative to understand the nature of the trial and providing signed informed consent. A child assent should also be obtained when the child is 7 years and older Stable residence in the study area during the two months after recruitment and willingness to comply with the study protocol and the study visit schedule
Exclusion criteria
Exclusion criteria: Antimalarial treatment with amodiaquine chloroquine quinine or lumefantrine within the previous 6 weeks with piperaquine or mefloquine or sulphadoxine pyrimethamine within the previous 3 months and with halofantrine or other artemisinin based compounds within the 30 days prior to screening Any other antimalarial treatment or antibiotics with antimalarial activity including cotrimoxazol and any herbal products within the 7 days prior to screening Children below five years presenting severe malnutrition defined as weight for height less than 70 percent of the median NCHS WHO reference Severe vomiting or dehydration Presence of jaundice Presence of intercurrent illness or any condition which in the Investigators judgement would place the patient at undue risk or interfere with the study results Known hypersensitivity to the artemisinin based therapy or piperaquine Clinical and or laboratory features of severe malaria according to WHO criteria Known severe renal impairment or liver insufficiency Moderate and severe anaemia Hb less 7 g per dL Pregnant or lactating females Female patients of child-bearing potential must be neither pregnant as demonstrated by a negative pregnancy test nor lactating and must be willing to take measures to not become pregnant during the study period Participation in any investigational drug study during the 30 days prior to screening or previously enrolled in the present trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of the administration of Eurartesim® in Indian children and adolescent patients affected by acute uncomplicated P. falciparum malariaTimepoint: 63 days followup | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Eurartesim® in treating acute uncomplicated malaria episodes and its ability in protecting patients from reinfections and/or recrudescence.Timepoint: 63 days | — |
Countries
India
Contacts
Public ContactDr Anup Anvikar
National Institute of Malaria Research
Outcome results
None listed