None listed
Conditions
Brief summary
Title: Efficacy and safety of Artesunate +Amodiaquine and Artemether+Lumefatrine for the treatment of uncomplicated Plasmodium falciparum malaria in Saclepea-Mah Comprehensive Health Center (Saclepea-Mah District, Nimba County), Rennie Hospital (Kakata District, Margibi County) and Sinje Health Center (Garwula District, Cape Mount County) in Liberia. Purpose: To assess the efficacy of the current first and/or second line treatment policy. Objective: To assess the efficacy and safety of Artesunate +Amodiaquine and Artemether+Lumefatrine for the treatment of uncomplicated P. falciparum malaria infections. Study Sites: Saclepea-Mah District in Nimba County, Kakata District in Margibi County and Garwula District, Cape Mount County. Study Period: September 2017 to June 2018 Study Design: Two cohorts prospective study in sequential enrollments. Patient population: Febrile patients aged 6 to 59 months with confirmed uncomplicated P. falciparum infection. Sample Size: 88 patients per site for each drug. Treatment(s) and follow-up: Artesunate+Amodiaquine (ASAQ) daily dose for three days and Artemether+Lumefatrine (AL) twice daily dose for three days will be administered. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. 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. Secondary endpoints: The frequency and nature of adverse events Exploratory endpoint: to determine the polymorphism of molecular markers for lumefantrine and artemisinin resistance.
Interventions
The aim of the study is to evaluates the efficacy and safety of artesunate+amodiaquine and artemether+lumefantrine with the following dosages:
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 2
The aim of the study is to evaluates the efficacy and safety of artesunate+amodiaquine and artemether+lumefantrine with the following dosages: 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 sequentially. The patient will be given artesunate+amodiaquine or artemether+lumefantrine and will be followed up for 28 days.
Sponsors
Ministry of Health of Liberia
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
1. age 6-59 months; 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 2000–200000/µl asexual forms; 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 visit schedule; 7. informed consent from a parent or guardian of children aged 6-59 months; 8. Patients living within 5 km radius of the health facility
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 6-59 months whose mid-upper arm circumference less than 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).
Outcome results
None listed