Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in two sites in Yemen.
- Conditions
- MalariaInfection - Studies of infection and infectious agents
- Registration Number
- ACTRN12617000283370
- Lead Sponsor
- Ministry of Public Health and Population
- Brief Summary
A total of 110 patients were recruited, six were lost to follow-up. The remaining 104 cleared parasites by day 3 and achieved adequate clinical and parasitological response on day 28. None of the samples of the study patients carried K13 mutation, marker of artemisinin resistanace.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 110
1.age 6 months and above, excluding female minors 12-17 years old and unmarried females aged 18 years and above;
2.mono-infection with P. falciparum detected by microscopy;
3.parasitaemia of 500-200000 per microL asexual forms;
4.presence of axillary temperature greater or equal to 37.5 degrees C 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 18 years;
8.informed assent from any minor participant aged from 12 to 17 years; and
9.consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under the age of majority years.
1.presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO;
2.weight under 5 kg;
3.mixed or mono-infection with another Plasmodium species detected by microscopy;
4.presence of severe malnutrition defined as a child aged 6-60 months who has a mid-upper arm circumference < 115 mm);
5.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);
6.regular medication, which may interfere with antimalarial pharmacokinetics;
7.history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
8.a positive pregnancy test or breastfeeding; and
9.unable to or unwilling to take pregnancy test or to use contraception for married women.
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 a composite primary outcome.<br><br>Enrolled patients will be assessed for parasitological (using microscopy) and clinical responses and treatment outcomes will be classified according to the latest WHO protocol. [At days 1, 2, 3, 7, 14, 21, 28 ]
- Secondary Outcome Measures
Name Time Method Percent of adverse event following treatment.<br>Atemether+lumefantrine are abdominal pain, asthenia, cough, diarrhoea, dizziness, fever, headache, joint and muscle pain, loss of appetite, rush, nausea, vomiting.<br><br>Parents or guardians of all enrolled 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. [At days 1, 2, 3, 7, 14, 21, 28 ];Prevalence of artemisinin resistance molecular markers (K13).<br><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). [At day 0 (prior to initiation of the treatment. ]