Efficacy and safety of artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum in Eritrea in 2022
Ministry of Health
352 participants
Sep 3, 2022
Interventional
Conditions
Summary
Efficacy of artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum in Eritrea was assessed in three sentinel sites: Tokombia, Shambuko, Goluj and Akordat. The study period was September to December 2022. This surveillance study is a one lane, The study enrolled 358 patients. Primary endpoint was the proportion of patients with treatment failure and secondary endpoints were proportions of K13 mutation and day 3 positive cases.
Eligibility
Inclusion Criteria9
- age between 6 months and above;
- infection with P. falciparum parasites confirmed by positive blood smear (no mixed infection);
- parasitaemia of 250-200, 000 asexual forms per microliter;
- presence of axillary or tympanic temperature greater or equal to 37.5 degree 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 follow-up visit schedule;
- informed consent from the patient or from a parent or guardian in the case of children aged less than 18;
- informed assent from any minor participant aged from 12 to 18 years; and
- Consent for pregnancy testing from female of child-bearing age (defined as age > 12 years and sexually active) and from their parent or guardian if under the age of 18.
Exclusion Criteria9
- presence of general danger signs in children aged under 12 years or signs of severe P. falciparum or P. vivax malaria according to the definitions of WHO;
- weight under 5 kg;
- haemoglobin < 8 g per deciliter;
- presence of severe malnutrition defined as a child aged between 6-60 months whose weight-for-high is below –3 z-score, or has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 115 mm).
- 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);
- 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);
- a positive pregnancy test or breastfeeding; and
- 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).
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Interventions
The study aims to assess the efficacy and safety of artesunate-amodiaquine once daily dose for three days for the treatment of uncomplicated Plasmodium falciparum infection. The dose regimen was based on body weight as follows: 1 tablet of 25+67.5 mg will be given to patient weighing 4.5 to <9 kg; 1 tablet of 50+135 mg to patient weighing 9 to <18 kg; 1 tablet of 100+270 mg to patient weighing 18 to <36 kg; 2 tablets of 100+270 mg. The target daily doses are approximately 4mg/kg BW of artesunate and 10mg/kg BW of amodiaquine. All treatments will be taken orally under direct supervision by the health worker and will be followed up for 28 days
Locations(1)
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ACTRN12625001329459