None listed
Conditions
Brief summary
An antimalarial drug efficacy trial will be conducted in Kassala (Kassala State), Kosti (White Nile state), Sinnar (Sinnar State), Damazin (Blue Nile State), Sudan. The participants will be febrile people above six month of age, excluding female minors aged 12-17 years inclusive and unmarried women above 17 years, with confirmed uncomplicated P. falciparum infection. Patients will be treated with Artesunate plus Sulfadoxine-pyrimethamine tablet, (4mg/kg of artesunate)+(25mg/kg sulfadoxine plus1.25mg/kg pyrimethamine) on the first day then 4mg/kg Artesunate on the following two days, or Artemether (20mg)/Lumefantrine (120mg) tablet, six-dose course over 3 days (2 doses daily) according to body weight. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. The study will be conducted from September 2013 to March 2014. The results of this study will be used to assist the Ministry of Health of Sudan in assessing the current national treatment guidelines for uncomplicated P. falciparum malaria.
Interventions
This surveillance study is a one arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated falciparum malaria. In five study sites eligible patients will be treated with artesunate at a dose of 4 mg per kg plus a fixed combination of sulfadoxine at a dose of 25 mg per kg and pyrimethamine at a dose of 1.25 mg per kg on the first day, then 4 mg per kg ofartesunate on the two following days. Patients will receive tablets containing 50
This surveillance study is a one arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated falciparum malaria. In five study sites eligible patients will be treated with artesunate at a dose of 4 mg per kg plus a fixed combination of sulfadoxine at a dose of 25 mg per kg and pyrimethamine at a dose of 1.25 mg per kg on the first day, then 4 mg per kg ofartesunate on the two following days. Patients will receive tablets containing 50 mg of artesunate and tablet containing 500 mg of sulfadoxine plus 25 mg of pyrimethamine. The number of tablets to be administered is determined according to body weight. In three other sites eligible patients will be administered fixed combination tablet, each containing 20 mg of artemether and 120 mg of lumefantrine, twice a day for three consecutive days. The number of tablets to be administered twice daily 8 hours apart is determined according to body weight: 5-14 kg, 1 tab; 15-24 kg, 2 tab; 25- 34 kg 3 tab; over 35kg 4 tab. Patients will be seen for clinical and parasitological evaluation, daily for the first 3 days, then weekly until day 28, or at any time if malaria syptoms re-occurred.
Sponsors
Republic of Sudan Federal Ministry of Health
Eligibility
Sex/Gender
All
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
Age above six months excluding female minors aged 12-17 years inclusive and unmarried women above 17 years; Mono-infection with P. falciparum detected by microscopy; Parasitaemia of 1000-100,00 per microlieter asexual forms; Presence of axillary temperature equal or greater 37.5 degrees Celsius, or history of fever during the past 24 h; Ability to swallow oral medication; Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and Informed consent from the patient or from a parent or guardian in the case of children.
Exclusion criteria
Presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO; Mixed or mono-infection with another Plasmodium species detected by microscopy; Presence of severe malnutrition (defined as a child whose growth standard is below –3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference less than 110 mm); Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS); Regular medication, which may interfere with antimalarial pharmacokinetics; History of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatments; and A positive pregnancy test or breastfeeding.
Outcome results
None listed