None listed
Conditions
Brief summary
Title: Efficacy and safety of Artesunate-amodiaquine (ASAQ) for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax in Eritrea. Purpose: To assess the efficacy of the existing first-line antimalarial drug and inform revision of the national malaria treatment guideline accordingly. Objective: To assess the efficacy and safety of Artesunate-amodiaquine for the treatment of uncomplicated P. falciparum and P. vivax. Study Sites: Tokombia, Shambuko, Goluj and Akordat. Study Period: The study will run for five months from August-December, 2019. Study Design: This surveillance study is a one-arm 28-day in-vivo prospective study. Patient population: Febrile patients aged 6 months and above, with microscopically confirmed uncomplicated P. falciparum and P. vivax. Sample Size: The study will enrol 88 patients per site to reach an overall sample size of 352 per species. Treatment(s) and follow-up: Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy of Artesunate-amodiaquine which is given for 3 days. Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response will be measured as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis. Secondary endpoints: The frequency and nature of adverse events will be recorded as part of monitoring safety of the drug. Optional exploratory endpoints: To determine the polymorphism of molecular markers for artemisinin resistance (ASAQ).
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 and Plasmodium viva malaria. administered 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 doses are 4mg/kg BW of Artesunate and 10mg/
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 and Plasmodium viva malaria. administered 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 doses are 4mg/kg BW of Artesunate and 10mg/kg BW of Amodiaquine given once a day for three days. All treatments will be taken orally under direct supervision by the health worker and will be followed up for 28 days.
Sponsors
Ministry of Health of Eritrea
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
1. age between 6 months and above; 2. infection with P. falciparum or P. vivax a parasites confirmed by positive blood smear (no mixed infection); 3. parasitaemia of 250-200, 000 asexual forms per microliter; 4. presence of axillary or tympanic 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 follow-up 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 > 12 years and sexually active) and from their parent or guardian if under the age of 18.
Exclusion criteria
1. 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; 2. weight under 5 kg; 3. haemoglobin < 8 g per deciliter; 4. 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). 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; 7. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); 8. a positive pregnancy test or breastfeeding; and 9. 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).
Outcome results
None listed