Health Condition 1: null- malaria Health Condition 2: B519- Plasmodium vivax malaria without complication
Conditions
Interventions
Intervention1: Primaquine,Artesunate,Chloroquine: 0.3mg/kg single dose orally of primaquine,2.4mg/kg single dose intravenous of artesunate,10mg/kg on day 1 and 2 and 5mg/kg on day 3 orally of chloroqu
Sponsors
Research society
Eligibility
Inclusion criteria
Inclusion criteria: 1.children below 12 years of age 2.children of either gender 3.children with confirmed cases of p.vivax malaria on microscopy by thick and thin smears 4.children with fever, chills, nausea, vomiting, headache, malaise, and not having signs/symptoms of severe malaria. 5.Willing to Consent & participate in the study. 6.normal G6PD status as assessed by qualitative and quantitative tests.
Exclusion criteria
Exclusion criteria: 1.children with G6PD deficiency 2.Known hypersensitivity to Chloroquine, primaquine or related drugs (e.g., iodoquinol) as assessed by history. 3.Persons receiving treatment with other potentially hemolytic drugs. 4.Any clinically significant diseases(hepatic, cardiac or pulmonary or subjects with acute nephritic syndrome) 5.History of autoimmune disease or acute or chronic bronchospastic disease (including asthma and COPD, treated or not treated) or clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis) 6.history of taking any anti-malarial drugs within last one month. 7.children with severe or complicated malaria or mixed malarial infections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study may help us to optimize the antimalarial drug therapy in malnourished children. It will help to assess safety and tolerability of these drugs in children. Timepoint: Two and half years after EC approval | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the safety and tolerability of antimalarial drugs and also optimum doses of anti-malarial drugs viz; Chloroquine, Primaquine and ArtesunateTimepoint: two and half years after EC approval | — |
Countries
India
Contacts
Public ContactPrashant Kadam
Seth G S Medical College and KEM Hospital
Outcome results
None listed