Efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine among children 6 to 59 months for the treatment of uncomplicated Plasmodium falciparum in Chad

Phase 4

Completed

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

• Registration Number: ACTRN12622001476729
• Lead Sponsor: Ministry of Public Health

Brief Summary

Two hundred fifteen children (114 in the artemether-lumefantrine group and 101 in the artesunate-amodiaquine group) were studied. At the end of 28 days, 111 and 94 children in the artemether-lumefantrine and artesunate-amodiaquine groups, respectively, achieved the desired endpoints. Cure rates of greater than 99% were observed with both treatments. All but one patient were free of parasites at day 3. None of the 215 day 0 samples carried a K13 mutation known to be associated with artemisinin partial resistance. Most samples carried crt wild type (79% to 89%). For the mdr-1 gene, the single 184F mutation, which has no clear impact on the efficacy of artemisinin-based combination therapies, was very common. Furthermore, the dhfr/dhps quintuple responsible for sulfadoxine/pyrimethamine treatment failures was not detected. No adverse events were observed in treated patients. The results of this study support the continued use of first- and second-line therapies for uncomplicated falciparum malaria and sulfadoxine/pyrimethamine for intermittent preventive treatment during pregnancy.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-02-20
• Study Start: 2022-11-23
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

• age from six to 59 months
• mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection);
• parasitaemia of 1000–200,000 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 to 59 months or signs of severe falciparum malaria according to the definitions of WHO.
• 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.
• 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
Proportion of treatment failures (early treatment failure + late clinical failure+late parasitological failure). This is a composite primary outcome.<br><br>Enrolled patients were monitored for clinical and parasitological (using microscopy) responses. Treatment outcomes was classified according to the latest WHO protocol.[Days 0 (prior to treatment), 1, 2 (during treatment),3, 7, 14, 21, 28 (post-treatment)]