Efficacy and safety of artemether- lumefantrine and artesunate - amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Mainland Tanzania

Phase 4

Completed

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

• Registration Number: ACTRN12622001243707
• Lead Sponsor: ational Institute for Medical Research

Brief Summary

One hundred seventy six patients (88 for artemether-lumefantrine and 88 for artesunate-amodiaquine)) infected with P. falciparum were recruited. The follow-up of patients has recently been completed. Quality control of parasite count and molecular analysis are also being planned.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-01
• Study Start: 2022-09-14
• Last Update Posted: 19 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

•age from six months to 10 years
•malaria Rapid Diagnostic Test (mRDT) positive
•mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection);
•parasitaemia of 500–200,000 per micrometer asexual forms;
•Presence of axillary or tympanic temperature greater or equal to 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 parent or guardian.

Exclusion Criteria

•presence of general danger signs in children aged between 6 months and 10 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1);
•mRDT negative results
•weight under 5 kg;
•haemoglobin below 8 g per dl;
•mixed or mono-infection with another Plasmodium species detected by microscopy;
•presence of severe malnutrition defined as a child who has symmetrical oedema involving at least the feet or has a mid-upper arm circumference below 110 mm in children greater or equal 59 months; or BMI of below 16 in children aged 5 years and above)
•presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea 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);

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 was monitored for parasitological (using microscopy) and clinical responses. Treatment outcomes was classified according to the latest WHO protocol.[Days 0 (before treatment), 1, 2 (during treatment),3, 7, 14, 21, 28 (post-treatment)]