None listed
Conditions
Brief summary
Title: Efficacy and safety of artesunate + amodiaquine for the treatment of uncomplicated Plasmodium falciparum infection in in Indonesia. Background: Therapeutic efficacy studies will be done in Indonesia to assess the efficacy and safety of artesunate-amodiaquine for the treatment of uncomplicated falciparum malaria. The study will be conducted in West Sumba District, East Nusa Tenggara Province of Indonesia. The participants will be febrile people equal to or above 6 months , inclusive. Patients will be treated with artesunate-amodiaquine daily for 3 days. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. The results of this study will be used to assist the Ministry of Health of Indonesia, in assessing the current national treatment guidelines for uncomplicated P. falciparum.
Interventions
One arm prospective evaluation with artesunate + amodiaquine given over 3 days for the treatment of uncomplicated Plasmodium falciparum malaria. Dose regimen: Oral tablets of artesunate 4 mg/kg + amodiaquine 10 mg/kg once daily for 3 consecutive days. Each dose administration will be observed and recorded.
Sponsors
Malaria sub-directorate, Directorate General of Disease control and Environmental Sanitation
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
3 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
*age between 3 to 65 years old excluding minor female aged 12-17 years; *mono-infection with P. falciparum detected by microscopy. *presence of P. falciparum malaria asexual 500-200000/ microliter; *presence of axillary equal to or more than 37.5 degrees centigrade or history of fever during the past 48 h; *ability to swallow oral medication; *ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and *informed consent from the patient or from a parent or guardian in the case of children.
Exclusion criteria
*presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of World Health Organization (WHO); *mixed or mono-infection with another Plasmodium species detected by microscopy; *presence of severe malnutrition (defined as a child whose growth standard is below 3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference below 110 mm); *presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, Human Immuno Deficiency Virus /Auto Immune Deficiency Syndrome(HIV/AIDS); *regular medication, which may interfere with antimalarial pharmacokinetics; *history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); * a positive pregnancy test * unable to or unwilling to take contraceptives
Outcome results
None listed