ACTRN12611001253998CompletedPhase 4
Efficacy and safety of artesunate+sulfadoxine/pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria in Kassala (Kassala State), Kosti (White Nile state), Sinnar (Sinnar State), Damazin (Blue Nile State), Sudan
Federal Ministry of Health of Sudan0 sites352 target enrollmentStarted: December 7, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 352
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 6 Months to 60 Years (—)
- Sex
- All
Inclusion Criteria
- •*age above 6 months with the exception of 12-17 years old female minors and unmarried females aged 18 years and above;
- •*mono-infection with P. falciparum detected by microscopy;
- •*parasitaemia of 1000 – 100000 /micro liter asexual forms;
- •*presence of axillary temperature greater or equal to 37.5 degrees centigrade 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 World Health Organization (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 < 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, Human Immuno Deficiency Virus /Auto Immune Deficiency Syndrome (HIV/AIDS);
- •*regular medication, which may interfere with antimalarial pharmacokinetics;
- •*history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); and
- •*a positive pregnancy test or breastfeeding;
- •*Unable to or unwilling to take a pregnancy test or contraceptives.
Investigators
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