Efficacy and safety of Artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in five sites in 2017, Eritrea

Phase 4

• Conditions: Malaria; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12618001223224
• Lead Sponsor: Ministry of Health, Eritrea

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-03-28
• Study Start: 2018-07-20
• Last Update Posted: 11 November 2019

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

1.age 6 months and above;
2.mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection);
3.parasitaemia of 250-200 000 asexual forms per microliter;
4.presence of axillary temperature greater or equal to 37.5 degree 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 18;
8.informed assent from any minor participant aged from 12 to 18 years; and
9.consent for pregnancy testing from female of child-bearing age (defined as age above 12 years and sexually active) and from their parent or guardian if under the age of 18 years.

Exclusion Criteria

1.presence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO;
2.weight under 5 kg;
3.haemoglobin below 8 g per deciliter;
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 < 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 was composite primary outcome.[Days 0, 1, 2, 3, 7, 14, 21, 28 (primary time point)]

Secondary Outcome Measures

Name	Time	Method
Percent of adverse event following treatment of artemether+lumefantrine.<br>The known adverse events of artemetherr+lumefantrine are abdominal pain, asthenia, cough, diarrhoea, dizziness, fever, headache, joint and muscle pain, loss of appetite, rush, nausea, vomiting.<br>Patients or Parents/guardians were asked routinely about previous symptoms and about symptoms that had emerged since the previous follow-up visit. When clinically indicated, patients was evaluated and treated appropriately. All adverse events was recorded on the case report form.<br>[Days 0, 1, 2, 3, 7, 14, 21, 28 ];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). The sample analysis is in process<br>[Day 0]