None listed
Conditions
Brief summary
Title: Efficacy and safety of dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax in 6 sentinel sites in Indonesia. Background: Based on the local efficacy studies in 2005, dihydroartemisinin-piperaquine (DHP) is recommended as the first line treatment for falciparum and vivax malaria in Indonesia in 2008. The National Malaria Control Program has put efforts in ensuring proper drug administration and regulation to prevent the emergence of drug resistance problem. In view of this, after 4 years of deployment it is important to evaluate the efficacy of DHP in different parts of Indonesia with different level of malaria transmission. Objective: To assess the efficacy and safety of DHP for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax infections in in 6 sentinel sites in Indonesia. Methods: An antimalarial drug efficacy trial will be conducted in 6 sentinel sites in Indonesia: Bangka Island (South Sumatra), Samarinda (East Kalimantan), Tomohon (North Sulawesi), South Halmahera (South Maluku), Flores (East Nusa Tenggara) and Timika (Papua). The participants will be older than one year to 65 years old with confirmed uncomplicated P. falciparum or P. vivax infection. Patients will be treated with once daily DHP (containing 40 mg dihydroartemisinin and 320 mg piperaquine) for 3 days, administered as a weight per dose regimen of 2.25 and 18 mg/kg per dose of dihydroartemisinin and piperaquine. Clinical and parasitological parameters will be monitored over a 42-day follow-up period to evaluate drug efficacy. The study will be conducted from August 2014 to July 2015. 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 Plasmodium falciparum and Plasmodium vivax malaria.
Interventions
To assess the efficacy and safety of dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax in 6 sentinel sites in Indonesia.
Dose regimen:
Dihydroartemisinin-piperaquine (tablet containing 40 mg dihydroartemisinin and 320 mg piperaquine): 2.25/18 mg/kg once daily for three consecutive days according to the following weight bands:6-10 kg body weight: 1/2 tablet, 11-17 kg body weight (bw): 1 tablet; 18-30 kg body weight (bw): 1 1/2 tablets;
To assess the efficacy and safety of dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax in 6 sentinel sites in Indonesia. Dose regimen: Dihydroartemisinin-piperaquine (tablet containing 40 mg dihydroartemisinin and 320 mg piperaquine): 2.25/18 mg/kg once daily for three consecutive days according to the following weight bands:6-10 kg body weight: 1/2 tablet, 11-17 kg body weight (bw): 1 tablet; 18-30 kg body weight (bw): 1 1/2 tablets; 31-40 kg body weight (bw): 2 tablets; 41-60 kg body weight: 3 tablets. The treatment will be taken orally under supervision of the study team. Eligibile subjects will be treated for three days and followed up for 28 days.
Sponsors
Ministry of Health
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 one year (weight more than 5 kgs) to 65 years old; *mono-infection with P. falciparum or P. vivax detected by microscopy; *parasitaemia of more than 1000/µl asexual parasites *presence of axillary temperature equal to or greater than 37.5 degrees Centigrade or history of fever during the past 24 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 WHO (Appendix 1); presence of danger signs as described in appendix 1 in patients with P. vivax infections *Unmarried females over 12 years of age or who have had their menarche *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 < 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, 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); and * a positive pregnancy test or breastfeeding in eligible married women (include this criterion only if adults are included)
Outcome results
None listed