Evaluation of the efficacy and safety of Artemether+Lumefantrine (Coartem®) with low-dose Primaquine for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in three sites of Savanakhet, Champasack, and Salavanh province, Lao PDR.
- Conditions
- MalariaInfection - Studies of infection and infectious agents
- Registration Number
- ACTRN12619000408189
- Lead Sponsor
- Ministry of Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 600
•Aged 6 months and above;
•Mono-infection with P. falciparum and P. vivax confirmed by positive blood smear (no mixed infection);
•P. falciparum parasitaemia of 250-100,000/µl asexual forms;
•P. vivax parasitaemia of 250-60,000/µl asexual forms
•Presence of axillary temperature greater than or equal to 37.5 °C 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 (Appendix 1);
•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 diarrhea 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);
•Women age 12-18 years old
•A positive pregnancy test or lactating
•Unable to or unwilling to take contraceptives for pregnancy negative married women of child- bearing age.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The study's primary outcome is the following composite outcome: 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.[28 days after treatment is the primary timepoint patient will be assessed daily on day 0,1,2 and 3 and weekly there after (D7;D14;D21) until Day 28]
- Secondary Outcome Measures
Name Time Method Evaluate safety by the incidence of adverse events assessed by clinical observation of symptoms For example vomitting, abdominal pain, and rashes[Any time adverse event occur between Day 0 and Day 28]