Efficacy and safety of Artemether - Lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in in sentinel sites in Mozambique.

Phase 4

Completed

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

• Registration Number: ACTRN12616001680459
• Lead Sponsor: Ministry of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

1. age from 6 to 59 months;
2. mono-infection with P. falciparum detected by microscopy;
3. parasitaemia of 2000 – 200000 asesual/microliter asexual forms;
4. presence of axillary temperature greater than 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 parent or guardian

Exclusion Criteria

1. presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the latest 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, (see appendix 2 for detailed list of prohibited medication during the study
7. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);

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><br>Enrolled patients will be assessed for parasitological (using microscopy), clinical responses during the 28 days follow-up and treatment outcomes will be classified according to the latest WHO protocol. [At day 28 following initiation of artemether+lumefantrine treatment. ]

Secondary Outcome Measures

Name	Time	Method
Percent of adverse event will be documented. The known adverse events of artemether/lumefantrine are abdominal discomfort, nausea, headache and dizziness. <br><br>Parents or guardians of all enrolled patients 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 day 28 following initiation of treatment ];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 initiation of treatment) ]