None listed
Conditions
Brief summary
Title: Efficacy and safety of dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax in 2 sentinel sites in Indonesia. Purpose: To assess the efficacy of the current first treatment policy Objective: To assess the efficacy and safety of dihydroartemisinin-piperaquine for the treatment of uncomplicated P. falciparum and P. vivax malaria infections. Study Sites: Papua Province and Bengkulu Province. Study Period: December 2016 to November 2017. Study Design: One arm prospective study. Patient population: Febrile patients aged between one year to 65 years old, with confirmed uncomplicated P. falciparum or P. vivax infection. Young female of child bearing age (between 12-17 years) will be excluded due to culturally sensitive reasons. Sample Size: A total of 120 patients (60 with P. falciparum and 60 with P. vivax malaria) will be enrolled in each site. Treatment(s) and follow-up: DHA-PIP (containing 40 mg dihydroartemisinin and 320 mg piperaquine) tablets will be administered once a day for 3 days, administered as a weight per dose regimen of 2.25 and 18 mg/kg of dihydroartemisinin and piperaquine. Clinical and parasitological parameters will be monitored over a 42-day follow-up period to evaluate drug efficacy. Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis. Secondary endpoints: The frequency and nature of adverse events. Optional exploratory endpoints: 1. to determine the polymorphism of molecular markers for artemisinin resistance (K13). 2. to determine the blood concentration of piperaquine.
Interventions
To assess the efficacy and safety of dihydroartemisinin-piperaquine (40/320 mg) for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria. Doses will be administered as 4 mg/kg dihydroartemisinin and 18 mg/kg piperaquine once a day for 3 days. The treatment will be given in tablets by oral. Eligible subjects will be treated for three days and followed up for 42 days. All treatments will be taken orally under direct supervision by the health worker.
Sponsors
Ministry of Health of Indonesia
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
1 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. age between one year to 65 years old, excluding female minors aged 12 to 17 years; 2. mono-infection with P. falciparum or P. vivax detected by microscopy; 3. parasitaemia of more than 500 asexual parasites per microliter for P. falciparum and 250 asexual parasites per microliter P.vivax 4. presence of axillary temperature greater or equal to 37.5 degrees C or history of fever during the past 24 h; 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; and 7. informed assent from any minor participant aged from 12 to 17 years (age of majority in the country); and 8. consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under the age of majority years.
Exclusion criteria
1. presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO; 2. weight under 5 kg; 3. mixed or mono-infection with another Plasmodium species detected by microscopy; 4. presence of severe malnutrition defined as a child aged 6-60 months has a mid-upper arm circumference below 115 mm); 5. 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); 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); and 8. a positive pregnancy test or breastfeeding (include this criterion only if adults are included) 9. unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age and who are sexually active.
Outcome results
None listed