Response of body to antimalarial drugs in childre
- Conditions
- Health Condition 1: null- malariaHealth Condition 2: B519- Plasmodium vivax malaria without complication
- Registration Number
- CTRI/2012/12/003188
- Lead Sponsor
- Research society
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 49
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The study may help us to optimize the antimalarial drug therapy in malnourished children. <br/ ><br>It will help to assess safety and tolerability of these drugs in children. <br/ ><br>Timepoint: Two and half years after EC approval <br/ ><br>
- Secondary Outcome Measures
Name Time Method 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