Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum in Afgoye site and Plasmodium vivax in Bosaso site, Somalia
- Conditions
- MalariaInfection - Studies of infection and infectious agents
- Registration Number
- ACTRN12618001224213
- Lead Sponsor
- World Health Organization Count Office Somalia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 85
1.age between 6 months and 60 years with the exception of 12-17years old female minors and unmarried females 18 years and above;
2.mono-infection with P. falciparum (Afgoye site) or P. vivax (Bosaso site) confirmed by positive blood smear (i.e. no mixed infection);
3.parasitaemia of 500 - 200000 per microliter asexual forms;
4.presence of axillary temperature greater or equal to 37.5 centigrade 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;
7.informed consent from the patient or from a parent or guardian in the case of children aged less than age of majority;
8.informed assent from any minor participant aged from 12 to age of majority years; and
9.consent for pregnancy testing from female of child-bearing age (defined as age below 12 years and sexually active) and from their parent or guardian if under the age of majority years.
1.presence of general danger signs in children aged under 12 years or signs of severe falciparum or vivax malaria according to the definitions of WHO;
2.female aged from 12 years and age of majority;
3.weight under 5 kg;
4.mixed or mono-infection with another Plasmodium species detected by microscopy;
5.presence of severe malnutrition defined as a child aged between 6-60 months who has a mid-upper arm circumference below 115 mm);
6.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);
7.regular medication, which may interfere with antimalarial pharmacokinetics;
8.history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
9.a positive pregnancy test or breastfeeding; and
10.unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age (defined as age above 12 years and sexually active).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent of treatment failures (early treatment failure + late clinical failure +late parasitological failure). This is composite primary outcome.<br>Study patients will be evaluated for parasitological and clinical responses during the 28 days follow-up and treatment outcomes will be classified according to the latest WHO protocol.[Days 0, 1, 2, 3, 7, 14, 21, 28 ];Percent of adverse event following treatment of artemether+lumefantrine 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.<br><br>Patients or care takers of children will be asked routinely about previous symptoms and about symptoms that have emerged since the previous follow-up visit. When clinically indicated, patients will be evaluated and treated appropriately. All adverse events will be recorded on the case report form.[Days 0, 1, 2, 3, 7, 14, 21, 28 ]
- Secondary Outcome Measures
Name Time Method Prevalence of artemisinin resistance molecular markers (K13).<br>Parasite DNA extracted from the dried blood spots will be analyzed by PCR and sequencing for the presence of K13 (molecular marker for artemisinin resistance).[Day 0 (before treatment is given)]