Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Djibouti-ville, Djibout
- Conditions
- MalariaInfection - Studies of infection and infectious agents
- Registration Number
- ACTRN12624000909527
- Lead Sponsor
- Ministry of Health of Djibouti
- Brief Summary
The quality control of slide reading and data validation are in progress.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 95
• age between 6 months and above;;
• mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection);
• parasitaemia of 500-200000 per micrometer asexual forms;
• presence of axillary temperature greater 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;
• informed consent from the patient or from a parent or guardian in the case of children aged less than 18 years;
• informed assent from any minor participant aged from 12 to age of majority years; and
• presence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO;
• weight under 5 kg;
• haemoglobin below 8 g per deciliter;
• mixed or mono-infection with another Plasmodium species detected by microscopy;
• presence of severe malnutrition defined as a child aged between 6-60 months who has a mid-upper arm circumference below 115 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);
• a positive pregnancy test or breastfeeding; and
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of treatment failures (early treatment failure + late clinical failure+late parasitological failure). This is a composite primary outcome.[Assessments were done clinically and parastologically using malaria microscopy. PCR analysis on blood samples on day 0 and day of parasite recurrence was done to differentiate recrudescence from new infection. Days 0 (prior to treatment), 1, 2 (during treatment),3, 7, 14, 21, 28 (post-treatment) for artemether-lumefantrine]
- Secondary Outcome Measures
Name Time Method Percent of adverse event following treatment of artemether-lumefantrine or dihydroartesmisinin-piperaquine will be investigated. <br>The known adverse events of atemether-lumefantrine are abdominal pain, asthenia, cough, diarrhoea, dizziness, fever, headache, joint and muscle pain, loss of appetite, rush, nausea, vomiting. Those for dihydroartemisinin include asthenia, cough, diarrhoea, fever, loss of appetite, nausea, vomiting.[Patients or care takers of children were asked on each visit about previous symptoms that have emerged since the previous follow-up visit. When clinically indicated, patients were assessed and treated appropriately. All adverse events will be recorded on the case report form. Days 0 (prior to treatment), 1, 2 (during treatment),3, 7, 14, 21, 28 (post-treatment) for artemether-lumefantrine]