Antimalarial Drug resistance study in West Bengal
- Conditions
- Health Condition 1: B509- Plasmodium falciparum malaria, unspecified
- Registration Number
- CTRI/2019/08/020575
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Mono infection with P falciparum detected by microscopy
parasitaemia of 1000 to 100000 per µl asexual forms
presence of axillary more or equal to 37.5 °C or history of fever during the past 48 h
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; and
Informed consent from the patient or from a parent or guardian in the case of children.
presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO
mixed or mono-infection with another Plasmodium species detected by microscopy
presence of severe malnutrition
presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases
regular medication, which may interfere with antimalarial pharmacokinetics
history of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatment and
a positive pregnancy test or breastfeeding;
unable to or unwilling to take contraceptives for women of child-bearing age
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To observe the evidence of artemisinin resistance in P falciparum malaria in eastern India. Efficacious antimalarial medicines are critical to malaria control. Continuous monitoring of their efficacy is needed to inform treatment policies in malaria-endemic countries, and to ensure early detection of, and response to, drug resistanceTimepoint: 28 days followup period
- Secondary Outcome Measures
Name Time Method To observe Kelch13 mutationTimepoint: 28 days