Malaria Infections and Infestations Plasmodium falciparum malaria
Conditions
Interventions
Artesunate 4 mg/kg/day over three days and sulfadoxine-pyrimethamine 25 mg/kg and 1.25 mg/kg single dose. The treatment is three days and the follow up is 28 days.
Contact details for
Sponsors
World Health Organization (WHO) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged over six months old, either sex 2. Uncomplicated mono-infection with Plasmodium falciparum 3. Parasitaemia, 1,000 - 100,000 asexual forms per µl 4. Axillary temperature greater than or equal to 37.5°C or oral/rectal temperature of greater than or equal to 38°C 5. Ability to swallow oral medication 6. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule 7. Informed consent from the patient or from a parent or guardian in case of children
Exclusion criteria
Exclusion criteria: 1. Presence of general danger signs among children less than five years old or other signs of severe and complicated falciparum malaria according to current WHO definitions 2. Mixed or mono-infection with another Plasmodium species 3. Presence of severe malnutrition (defined as a child whose weight-for-height is below -3 standard deviation or less than 70% of the median of the National Center for Health Statistics (NCHS)/WHO normalised reference values, or who has symmetrical oedema involving at least the feet or who has a mid-upper arm circumference [MUAC] less than 110 mm) 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 diseases (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 mothers (if adults included)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the proportion of patients with early treatment failure (ETF), late clinical failure (LTF), late parasitological failure (LPF), or with an adequate clinical and parasitological response (ACPR) as indicators of efficacy 2. To evaluate the incidence of adverse events The outcome measure is at day 28 except if the patient fails or is lost to follow-up or withdrawn from the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Pakistan
Outcome results
None listed