Malaria Infections and Infestations Malaria
Conditions
Interventions
1. Artesunate (12 mg/kg) and sulfadoxine (25 mg/kg single dose) - pyrimethamine (1.25 mg/kg single dose) over 3 days for falciparum malaria
2. Chloroquine 25 mg/kg over 3 days for vivax malaria
Conta
Sponsors
World Health Organization (WHO) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age above 6 months 2. Mono-infection with P. falciparum or P. vivax 3. Parasitaemia, 1000 - 100,000 asexual forms per µl for falciparum malaria and above 250 asexual forms per µl for vivax malaria 4. Axillary temperature of 37.5°C or oral/rectal temperature of 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 5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions (see Annex 1) 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 (if adults included)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To measure the clinical and parasitological efficacy of artesunate and sulfadoxine-pyrimethamine among patients aged above six months suffering from uncomplicated falciparum malaria and chloroquine for vivax malaria, by determining the proportion of patients with: 1.1. Early Treatment Failure (ETF) 1.2. Late Clinical Failure (LTF) 1.3. Late Parasitological Failure (LPF) 1.4. Adequate Clinical and Parasitological Response (ACPR) As indicators of efficacy 2. To differentiate recrudescences from new infections by the Polymerase Chain Reaction (PCR) analysis 3. To evaluate the incidence of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Afghanistan
Outcome results
None listed