Uncomplicated Plasmodium falciparum and vivax malaria Infections and Infestations
Conditions
Interventions
This surveillance study is a one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria. People with uncomplicated falciparum and
Sponsors
World Health Organization Regional Office for South-East Asia
National Natural Science Foundation of China
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 6 months and 60 years 2. Mono-infection with P. falciparum or P. vivax detected by microscopy 3. Mono-infection with P. falciparum detected by microscopy with parasitaemia of 500-100,000/µl asexual forms 4. Mono-infection with P. vivax detected by microscopy with parasitaemia of =250/µl asexual forms 5. Axillary or tympanic temperature =37.5°C or oral or rectal temperature of =38°C or history of fever during the past 24 h 6. Able to swallow oral medication 7. Able and willing to comply with the study protocol for the duration of the study and to comply with the study visit schedule 8. Informed consent from the patient or from a parent or guardian in the case of children aged less than 18 years 9. Informed assent from any minor participant aged from 12 to age of 18 years 10. Consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under the age of 18 years
Exclusion criteria
Exclusion criteria: 1. Presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to WHO definitions 2. Weight under 5 kg 3. Mixed infection or mono-infection with another Plasmodium species detected by microscopy 4. Presence of severe malnutrition defined as a child aged 6-60 months whose weight-for-height is below –3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 115 mm) 5. Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS) 6. Regular medication, which may interfere with antimalarial pharmacokinetics 7. History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s) 8. Positive pregnancy test or breastfeeding 9. Unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age and who are sexually active
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Early treatment failure, defined as any one of the following: 1.1. Danger signs or severe malaria on day 1, 2 or 3 in the presence of parasitaemia 1.2. Parasitaemia on day 2 higher than on day 0, irrespective of axillary temperature 1.3. Parasitaemia on day 3 with axillary temperature =37.5ºC 1.4. Parasitaemia on day 3 =25% of count on day 0 2. Late clinical failure, defined as any one of the following: 2.1. Danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 28 for P. vivax patients and day 42 for P. falciparum patients in patients who did not previously meet any of the criteria of early treatment failure 2.2. Presence of parasitaemia on any day between day 4 and day 28 for P. vivax patients and day 42 for P. falciparum patients with axillary temperature =37.5ºC (or history of fever) in patients who did not previously meet any of the criteria of early treatment failure 3. Late parasitological failure, defined as presence of parasitaemia on any day between day 7 and day 28 for P. vivax patients and day 42 for P. falciparum patients with axillary temperature <37.5ºC in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure 4. Adequate clinical and parasitological response, defined as absence of parasitaemia on day 28 for P. vivax patients and day 42 for P. falciparum patients, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| The frequency and nature of adverse events | — |
Countries
China
Outcome results
None listed