None listed
Conditions
Brief summary
A study was conducted in 2016 to assess the efficacy of artesunate+amodiaquine (ASAQ) and patterns of molecular markers for artemisinin resistance. The study was conducted in 4 sentinel sites (Tesseney Hospital, Goluj Health Center, Tekombia Health Center, Shambuko Health Center). It was one-arm prospective assessment of clinical and parasitological outcomes to directly observed standard therapeutic regimen of ASAQ for the treatment of uncomplicated falciparum malaria. Patients aged 6 months and above were followed up 28 days following treatment. Prevalence of K13 mutations was investigated. A total of 280 were recruited from the four sites. The laboratory analysis for differentiating recrudescence from new infection as well as for K13 mutations are underway.
Interventions
The aim of the study was to evaluates the efficacy and safety of artesunate+amodiaquine among patients suffering from uncomplicated falciparum malaria treated with a daily oral tablet dose of artesunate 4 mg/kg bw + amodiaquine 10mg/kg for 3 consecutive days. The patients were treated under direct supervision and 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 6 months and above; 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 250–200,000/µl asexual forms; 4. presence of axillary temperature greater or equal to 37.5 degrees centigrade or history of fever within the last 24 hours;; 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 the patient or from a parent or guardian in the case of children aged less than 18 years 8. informed assent from any minor participant aged from between 12 and 18 to age of majority years; and 9. consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under the age of 18 years.
Exclusion criteria
1. presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the 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; 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 and who are sexually active.
Outcome results
None listed