Health Condition 1: B509- Plasmodium falciparum malaria, unspecified
Conditions
Interventions
None listed
Sponsors
World Health Organization Country Office for India
ICMR National Institute for Research in Tribals Health
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between minimum age 1 year to maximum age 65 years 2. Mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection) 3. Parasitaemia of (1000)â??(100000)/µl asexual forms 4. Presence of axillary temperature >= 37.5 °C or history of fever during the past 24 h 5. Ability to swallow oral medication 6. Ability and willingness to comply with the study protocol for the duration of the study 7. Informed consent from the patient or from a parent or guardian in the case of children aged less than age of majority 8. Informed assent from any minor participant aged from 12 to age of majority years 9. Only if consent for pregnancy testing from female of child-bearing age (defined as age > 12 years and sexually active) and from their parent or guardian if under the age of majority years.
Exclusion criteria
Exclusion criteria: 1. Presence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO 2. Weight under 5 kg 3. Haemoglobin 4. Mixed or mono-infection with another Plasmodium species detected by microscopy 5. Presence of severe malnutrition defined as a child aged between 6-60 months whose weight-for-high is below â??3 z-score, or has symmetrical oedema involving at least the feet or has a mid-upper arm circumference 6. Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS) 7. Regular medication, which may interfere with antimalarial pharmacokinetics 8. History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s) 9. A positive pregnancy test or breastfeeding 10. Unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age (defined as age > 12 years and sexually active)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The results of the study will be used to assist the Ministry of Health and Family Welfare, Government of India in assessing the current national treatment guidelines for uncomplicated Plasmodium falciparum malariaTimepoint: one Year | — |
Secondary
| Measure | Time frame |
|---|---|
| The frequency and nature of adverse events and to determine the polymorphism of molecular markers for artemisinin resistanceTimepoint: One year | — |
Countries
India
Contacts
Public ContactDr Praveen K Bharti
ICMR National Institute for Research in Tribals Health
Outcome results
None listed