None listed
Conditions
Brief summary
Title: Efficacy and safety of artesunate+amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in district hospital of Massakory, Hadier Lamis region of Chad Purpose: To assess the efficacy and safety of the first-line treatment. Objective: To assess the efficacy and safety of artesunate+amodiaquine for the treatment of uncomplicated P. falciparum malaria infections. Study Sites: District hospital of Massakory, Hadier Lamis region of Chad. Study Period: The study will be conducted from 1 August to 1st October 2015. Study Design: A one arm prospective study. Patient population: Febrile patients aged between 6 months and 5 years with confirmed uncomplicated P. falciparum infection will be enrolled. Sample Size: A total of 103 patients will be enrolled. Treatments and follow-up: artesunate+amodiaquine given daily dose 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: The frequency of adverse events and polymorphism of molecular markers for artemisinin resistance.
Interventions
To assess the efficacy and safety of artesunate+amodiaquine
(artesunate 4 mg/kg body weight + amodiaquine 10mg/kg body weight once daily for 3 consecutive days) for the treatment of uncomplicated P. falciparum infection. The treatment will be taken orally under direct supervision by the health worker. Eligibile subjects will be treated for three days and followed up for 28 days.
Sponsors
Ministry of Health of Chad
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 5 Years
Healthy volunteers
No
Inclusion criteria
1. age between six months and 5 years; 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 1000–100,000/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 parent or guardian in the case of children
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 has a mid-upper arm circumference belo 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