Health Condition 1: null- Malaria
Conditions
Interventions
Intervention1: Chloroquine + Primaquine: Oral administration under direct observation. Choroquine â?? 25mg/ kg body wt. base for 3 days as â?¢ 10mg/ kg body wt. on Day1 â?¢ 10mg/ kg body wt. on Day2 â
Sponsors
Department of Health and Family Welfare Govt of West Bengal
Eligibility
Inclusion criteria
Inclusion criteria: According to WHO Protocol 2009 Inclusion criteria age over 6 months mono-infection with P. vivax detected by microscopy asexual parasite count 1000 â?? 1,00,000/µl axillary temperature >= 37.5 °C or history of fever during the 48 h before recruitment ability to swallow oral medication ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule informed consent from the patient or from a parent or guardian in the case of children absence of a clinical condition due to vivax malaria (coma, respiratory distress syndrome or severe anaemia) requiring hospitalization absence of severe malnutrition according to WHO child growth standards absence of a febrile condition due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or ystemic disease (e.g. cardiac, renal or hepatic disease, HIV/AIDS). absence of regular medication, which might interfere with anti-malarial pharmacokinetics
Exclusion criteria
Exclusion criteria: Exclusion criteria Presence of one or more of the general danger signs or any sign of severe or complicated malaria Presence of mixed infection Presence of severe malnutrition Presence of febrile conditions caused by diseases other than malaria Presence of a severe disease Contraindication related to anti-malarial drugs used, specially h/o allergy Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As per Methods for surveillance of antimalarial drug efficacy, WHO â?? 2009 (PCR uncorrected therapeutic efficacy outcome 28 days follow-up) ETF: Early Treatment Failure, LPF: Late Parasitological Failure, LCP: Late Clinical Failure, and ACPR: Adequate Clinical and Parasitological ResponseTimepoint: 28 days for each patients from the date of enrollment. | — |
Secondary
| Measure | Time frame |
|---|---|
| As per Methods for surveillance of antimalarial drug efficacy, WHO â?? 2009 (PCR corrected therapeutic efficacy outcome 28 days follow-up) ETF: Early Treatment Failure, LPF: Late Parasitological Failure, LCP: Late Clinical Failure, and ACPR: Adequate Clinical and Parasitological ResponseTimepoint: 28 days followup | — |
Countries
India
Contacts
Public ContactDr Ardhendu Maji
Calcutta school of Tropical Medicine
Outcome results
None listed