Efficacy and safety of Dihydroartemisinine-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria, and chloroquine for Plasmodium vivax in Homalin (Sagaing Division), Lashio (Shan State) and Bokepyin (Tanintharyi Division).
A study evaluating the efficacy and safety of Dihydroartemisinine-piperaquine for the treatment of uncomplicated plasmodium falciparum malaria, and chloroquine for plasmodium vivax in Homalin (Sagaing Division), Lashio (Shan State) and Bokepyin (Tanintharyi Division)
Clinical Research Unit (malaria), Defense Services General Hospital
200 participants
Jan 1, 2014
Interventional
Conditions
Summary
To study the efficacy of antimalarial drugs in Myanmar.
Eligibility
Inclusion Criteria6
- age above 13 years inclusive and above except females aged 13-17 year old inclusive;
- mono-infection with P. falciparum detected by microscopy (parasitaemia of 500-100,000/micro litre asexual forms) or P. vivax detected by microscopy (parasitaemia greater than 250/micro litre asexual forms);
- presence of axillary equal to 37.5 degrees celsius 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 Criteria7
- presence signs of severe falciparum malaria according to the definitions of WHO;
- mixed or mono-infection with another Plasmodium species detected by microscopy;
- 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;
- unable to or unwilling to take a pregnancy test or contraceptives.
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Interventions
All patients are over 13 years of age. For patients with plasmodium falciparum malaria dihydroartemisinin-piperaquine will be administered 2-2.4/16-19.2 mg/kg (Body weight will be recorded on day 0 to the nearest kilogram on a Salter scale. Patients should not wear excessive clothing while being weighed as this can overestimate their true weight. The screening weight will be used to satisfy the inclusion or exclusion for nutrition status as well as to calculate the dose (number of tablets) to be administered) once a day orally for 3 days. Less than 18 kgs will be given one tablet per day. Less than 29 kgs will be given 1 and a half tablets per day, less than 39 kgs will be given 2 tablets per day and over 40 Kgs will be given three tablets per day. Each tablet contains 40mg dihydroartemisinin and 320mg piperaquine phosphate. For patients with P. vivax malaria will be administered with chloroquine 10 mg, 10 mg and 5 mg per kg orally on day 0, 1 and 2 respectively. Enrolled patients will be observed for at least 30 min after treatment to ensure that they do not vomit the medicine. If vomiting occurs within 30 min of treatment, the full treatment dose will be repeated. Thereafter, patients are required to undergo regular clinical reassessment. Blood films for parasite counts will be made on days 2, 3 and 7 and then weekly for the remainder of the follow-up period, i.e. on days 14, 21, 28.
Locations(3)
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ACTRN12614000214639