None listed
Conditions
Brief summary
Title: Efficacy and safety of Artemether - Lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in in sentinel sites in Mozambique. Purpose: To assess the efficacy and safety of the current first line treatment policy; Objective: To assess the efficacy and safety of Artemether - Lumefantrine for the treatment of uncomplicated P. falciparum malaria infections. Study Sites: Cabo-Delgado in the northern region; Tete and Sofala in the Central region and Gaza in the Southern region of Mozambique. Study Period: The study will be conducted from March to August 2015. Study Design: One arm prospective study. Patient population: Febrile patients aged 6 to 59 months, with confirmed uncomplicated P. falciparum infection. Sample Size: 88 patients will be enrolled in each site. Treatment(s) and follow-up: Artemether - Lumefantrine twice daily dose for three days. 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. Optional exploratory endpoints: to determine the polymorphism of molecular markers for name of artemisinin resistance;
Interventions
To assess the efficacy and safety of artemether/lumefantrine (20mg/120mg: 3 day regimen of twice daily dose of 1 tablet for 5-14 kg; 2 tablets for 15-24 Kg) 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
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 59 Months
Healthy volunteers
No
Inclusion criteria
1. age from 6 to 59 months; 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 2000 – 200000 asesual/microliter asexual forms; 4. presence of axillary temperature greater than 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 parent or guardian
Exclusion criteria
1. presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the latest 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, (see appendix 2 for detailed list of prohibited medication during the study 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