None listed
Conditions
Brief summary
The efficacy and safety of artesunate-amodiaquine and artemether+lumefantrine for the treatment of uncomplicated P. falciparum malaria will be assessed in two districts. It is single prospective study where artesunate+amodiaquine will be tested in one district and artemether+lumefantrine will tested in the other district. Febrile patients aged 6 months and above with confirmed uncomplicated P. falciparum infection will be enrolled. A sample Size of 88 patients per drug per site per district. Patients will be treated with the WHO recommended standard doses of artesunate-amodiaquine (daily dose for 3 days) and artemether-lumefantrine (twice daily for 3 days). Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy and safety. Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis. Day 3 malaria positivity rate will determined. Secondary endpoints: 1. The frequency of adverse events. 2. Frequency of molecular markers for artemisinin resistance (K13)
Interventions
To assess the efficacy and safety of the three drugs, the following dosages will be give:
Artesunate-amodiaquine: 4 mg/kg artesunate + 10mg/kg amodiaquine once daily for 3 consecutive days will be given.
Artemether-lumefantrine containing 20 mg artemether+ 120 mg lumefantrine in each tablet will be given twice daily for three days according to the recommended weight bands as follows: 1 tablet to those weighing 5 to 14 kg; 2 tablets for 15 to 24 kg; 3 tablets for 25 to 34 kg and 4 tablets for equ
To assess the efficacy and safety of the three drugs, the following dosages will be give: Artesunate-amodiaquine: 4 mg/kg artesunate + 10mg/kg amodiaquine once daily for 3 consecutive days will be given. Artemether-lumefantrine containing 20 mg artemether+ 120 mg lumefantrine in each tablet will be given twice daily for three days according to the recommended weight bands as follows: 1 tablet to those weighing 5 to 14 kg; 2 tablets for 15 to 24 kg; 3 tablets for 25 to 34 kg and 4 tablets for equal or greater than 35 kg. The total target dose ranges are 5-24 mg/kg bw of artemether and 29-144 mg/kg bw of lumefantrine. All treatments will be taken orally under direct supervision by the health worker. The two drugs will be tested separately. The patient will be given artesunate+amodiaquine or artemether+lumefantrine and will be followed up for 28 days.
Sponsors
Ministry of Health of Sao Tome and Principe
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 60 Years
Healthy volunteers
No
Inclusion criteria
1. age from 6 months to 60 years; 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 500–100,000/microliter asexual forms; 4. presence of axillary temperature greater or equal to 37.5 degrees C 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 visit schedule; 7. informed consent from the patient or parent/ guardian of children. 8. informed assent from any minor participant aged from 12 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 majority 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. Haemoglobin < 8g/dl; 4. mixed or mono-infection with another Plasmodium species detected by microscopy; 5. presence of severe malnutrition defined as a child aged 6-60 months has a mid-upper arm circumference below 115 mm) 6. 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); 7. regular medication, which may interfere with antimalarial pharmacokinetics; 8. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); 9. a positive pregnancy test or breastfeeding; and 10. 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