None listed
Conditions
Brief summary
Title: Efficacy and safety of artesunate+sulfadoxine/ pyrimethamine and artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Bosaso, Puntland, Somalia. Purpose: To assess the efficacy of the current first and second line treatment policy. Objective: To assess the efficacy and safety of artesunate+sulfadoxine/pyrimethamine and artemether+lumefantrine for the treatment of uncomplicated P. falciparum malaria infections. Study Sites: Bosaso site in North East Zone (Puntland). Study Period: From December 2014– March 2015 . Study Design: One arm prospective study. Patient population: Febrile patients aged between 6 months and 60 years, inclusive, with confirmed uncomplicated P. falciparum infection. Female minors aged 12-17 years and unmarried females aged above 18 years and above will be excluded as subjecting them to pregnancy testing is unacceptable according to the local customs and cultures. Sample Size: A total of 88 patients will be enrolled in the study per each antimalarial drug. Treatment(s) and follow-up: artesunate+sulfadoxine/pyrimethamine and artemether+lumefantrine will be evaluated. For the artesunate+sulfadoxine/pyrimethamine, a daily dose of artesunate 4 mg/kg bw for three days plus a single dose of 25/1.25 mg/kg bw of sulfadoxine/pyrimethamine in the first day will be administered under direct observation. For the artemether+lumefantrine, a fixed combination of 20 mg of artemether and 120 mg of lumefantrine in a tablet will be administered according to the recommended weight as follows: One tablet to those weighing 5-14kg; two tablets for 15-24 kg; three tablets for 25-34 kg and four tablets for greater than or equal to 35 kg. The full course of artemether+lumefantrine for all study patients consists of 6-doses given twice daily over 3 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 Exploratory endpoints: 1. to determine the polymorphism of molecular markers for sulfadoxine/pyrimethamine and artemisinin (K13) resistance.
Interventions
To assess the efficacy and safety of (i)artesunate+sulfadoxine/pyrimethamine (standard dose of artesunate 4 mg/kg bw for three days plus a single dose of 25/1.25 mg/kg bw of sulfadoxine/pyrimethamine in the first day ) and (ii) artemether/lumefantrine (20 mg of artemether and 120 mg of lumefantrine in a tablet with dose regimen of: one tablet to those weighing 5-14kg; two tablets for 15-24 kg; three tablets for 25-34 kg and four tablets for greater or equal to 35 kg) for the treatment of uncompl
To assess the efficacy and safety of (i)artesunate+sulfadoxine/pyrimethamine (standard dose of artesunate 4 mg/kg bw for three days plus a single dose of 25/1.25 mg/kg bw of sulfadoxine/pyrimethamine in the first day ) and (ii) artemether/lumefantrine (20 mg of artemether and 120 mg of lumefantrine in a tablet with dose regimen of: one tablet to those weighing 5-14kg; two tablets for 15-24 kg; three tablets for 25-34 kg and four tablets for greater or equal to 35 kg) for the treatment of uncomplicated P. falciparum infection. The treatment will be taken orally under health worker's supervision. Eligibile subjects will be treated for three days (daily dose for artesunate+sulfadoxine/pyrimethamine and twice daily dose for artemether lumefantrine) and followed up for 28 days.
Sponsors
Ministry of Health, Puntland, Somalia
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 60 Years
Healthy volunteers
No
Inclusion criteria
1. age between 6 months and 60 years with the exception of 12-17 years old female minors and unmarried females above 18 years and above; 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 500 - 200000 per microliter asexual forms; 4. presence of axillary temperature greater or equal 37.5 degrees 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 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 12 to age of majority years; and 9. consent for pregnancy testing from married female of 18 years and above.
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 of married women aged 18 years and above; 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