Health Condition 1: null- Parient suffering from uncomplicated falciparum malaria
Conditions
Interventions
Intervention1: Artemether Lumefantrine: Administered as per National policy of that area
Sponsors
WHO GMP
Eligibility
Inclusion criteria
Inclusion criteria: 1 age between 1 year to 65 years 2 Mono infection with P. falciparum detected by microscopy 3 asexual forms parasitaemia of 1000 to 100000 per microlitre of blood 4 presence of axillary temperature equal and more than 37 5 Centigrade or history of fever during the past 48 hours 5 ability to swallow oral medication ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule 6 informed consent from the patient or from a parent or guardian in the case of children
Exclusion criteria
Exclusion criteria: 1 presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO 2 mixed or mono-infection with another Plasmodium species detected by microscopy 3 presence of severe malnutrition 4 presence of febrile conditions due to diseases other than malaria eg measles acute lower respiratory tract infection severe diarrhoea with dehydration or other known underlying chronic or severe diseases eg cardiac renal and hepatic diseases HIV AID 5 regular medication which may interfere with antimalarial pharmacokinetics 6 history of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatments 7 a positive pregnancy test or breastfeeding unable to or unwilling to take contraceptives for women of child-bearing age 8 Minor girls aged less than 18 years who have achieved menarche
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy and safety of artemether Lumefantrine (AL) for the treatment of uncomplicated P. falciparum infections in Lunglei district (Mizoram); Changlang district (Arunachal Pradesh), Gomati district or Dhalai district (Tripura) in India.Timepoint: 42 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the polymorphism of molecular markers for artemether-lumefantrine resistance and To determine the blood concentration of artemether lumefantrine Timepoint: 42 days | — |
Countries
India
Contacts
Public ContactNeena Valecha
National Institute of Malaria Research
Outcome results
None listed