Efficacy and safety of artesunate and dihydroartemisinin-piperaquine tablets for the treatment of uncomplicated Plasmodium falciparum malaria and Chloroquine for the treatment of Plasmodium vivax malaria in Bu Dang of Binh Phuoc, Tuy Duc of Dak Nong, Huong Hoa of Quang Tri and Gia Lai provinces, Viet Nam in 2010
- Conditions
- MalariaInfection - Studies of infection and infectious agents
- Registration Number
- ACTRN12611000175976
- Lead Sponsor
- Ministry of Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
age between 02 to 60 years old;
- mono-infection with P. falciparum or P. vivax detected by microscopy;
- Pf= parasitaemia of 500 – 100,000 asexual forms/ micro ml of blood;
- Pv = parasitemia 250-50,000 asexual forms/ micro ml of blood;
- presence of axillary temperature greater than or equal
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.
- presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of 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 < 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
- Single female with ages 12 – 18 years old.
- a positive pregnancy test or breastfeeding.
- unable to or unwilling to take contraceptives (for women of child-bearing age).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome 1: 28/42 -day cure rate or ACPR (adequate clinical and parasitological response)<br> (absence of parasitaemia on day 28/42, 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)[after start of the study : Day 1, Day 2, Day 3, Day 7, Day 14, Day 21, Day 28, Day 35 and Day 42]
- Secondary Outcome Measures
Name Time Method PCR-corrected ACPR (PCR: polymerase chain reaction, a molecular tool/test to differentiate if the failure is a true resistance or reinfection)[after start of study (Day 7, Day 14, Day 21, Day 28 with artesunate, chloroquine, Day 35 and Day 42 with Dihydroartemisinin - Piperaquine)]