Malaria Infections and Infestations Malaria
Conditions
Interventions
Patients will be randomised into the following treatment groups (2:1):
Group A: fixed-dose AS/AQ combination tablets (paediatric: 25 mg/67.5 mg - adult: 100 mg/270 mg), oral route, dose according to a
Sponsors
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children and adults from 6 months to 60 years of age, both genders 2. For children: body weight greater than 5 kg 3. Uncomplicated falciparum malaria 4. Axillary temperature greater than 37.5°C 5. P. falciparum parasitaemia 1000 - 100,000 asexual forms/µL 6. Ability to swallow oral medication 7. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule 8. Written informed consent (participant or parent/guardian)
Exclusion criteria
Exclusion criteria: 1. Presence of general danger signs among the children less than 5 years old or other signs of severe and complicated falciparum malaria according to current World Health Organization (WHO) definitions 2. Mixed or mono-infection with another Plasmodium species 3. Presence of severe malnutrition 4. Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhoea with dehydration, etc.) or other known underlying chronic or severe disease (e.g. cardiac, renal, hepatic diseases, human immunodeficiency virus [HIV]/acquired immune deficiency syndrome [AIDS]) 5. History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment 6. Positive pregnancy test or lactating 7. H/O antimalarial treatment in past 15 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure rate: proportion of patients with 'Adequate Clinical and Parasitological Response' (ACPR) as defined by WHO | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints: 1. Parasite reduction ratio (PRR) at 48 hours 2. Parasite clearance time 3. Fever clearance time 4. Proportion of patients with gametocytes persistence at end-of-treatment 5. Proportion of patients with early treatment failure (ETF), late treatment failure (LTF), and late parasitological failure (LPF) Safety variables: Incidence of any adverse event will be documented. All patients will be routinely asked about old symptoms and new symptoms emerging since previous visit | — |
Countries
India
Outcome results
None listed