Malaria
Conditions
Interventions
Artemether and Lumefantrine
Sponsors
Clinica Multiperfil
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 2 years; • Mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection); • Parasitemia 2000 – 200,000 /µl of asexual forms of P. falciparum; • Presence of axillary temperature = 37.5ºC or without fever at the time of evaluation or with a history of fever in the last 24 hours; • Ability to swallow oral medication; • Ability and willingness to comply with the study protocol during the study and adhere to the study visit schedule; • Informed consent from the patient or a parent or guardian in the case of minor children; • Informed consent from any participant under the age of 12 until the age of majority.
Exclusion criteria
Exclusion criteria: • Presence of general danger signs in children under 12 years of age or signs of severe falciparum malaria according to WHO definitions; • Weight less than 5 kg; • Hemoglobin < 8 g/dl; • Mixed or mono infection with another species of Plasmodium detected by microscopy; • Presence of severe malnutrition defined as a child aged between 24-60 months whose weight is below -3 scores; • Presence of febrile conditions due to illnesses other than malaria (e.g., measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or serious illnesses (e.g., heart, kidney, and liver disease, HIV /AIDS); • Regular medication, or use of teas, which may interfere with the pharmacokinetics of antimalarials; • History of hypersensitivity reactions or contraindications to any of the medications tested or used as alternative treatments; • A positive pregnancy test or breastfeeding; • Unable or reluctant to take contraceptives (in adult women/childbearing age).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Measure the clinical and parasitological efficacy of Artemether and Lumefantrine (AL)/Coartem® in patients aged = 2 years, with uncomplicated falciparum malaria, determining the proportion with early therapeutic failure, late clinical failure, late parasitological failure, or adequate clinical and parasitological response as indicators of efficacy;;• Differentiate recrudescence from new infection through polymerase chain reaction (PCR) analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the incidence of adverse events;;Assess the ex vivo/in vitro susceptibility of P. falciparum isolates to antimalarial drugs;Determination of the frequency of molecular markers present in drug resistance associated genes such as in pfk13, pfmdr1, pfcrt, and pfpm2 genes that confer resistance to artemisinin, lumefantrine, amodiaquine, and piperaquine | — |
Countries
Angola
Contacts
Public ContactMaria da Neves Pereira
Internal medicine doctor and executive member of the Multiperfil Clinic
Outcome results
None listed