Status:
COMPLETED
Efficacy and Safety of ASAQ and PD for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania
Lead Sponsor:
National Institute for Medical Research, Tanzania
Collaborating Sponsors:
Muhimbili University of Health and Allied Sciences
World Health Organization
Conditions:
Uncomplicated Falciparum Malaria
Eligibility:
All Genders
6-10 years
Phase:
PHASE4
Brief Summary
The World Health Organization recommends regular surveillance of antimalarial efficacy to monitor the performance of different drugs. The Tanzanian National Malaria Control Programme (NMCP) in collabo...
Eligibility Criteria
Inclusion
- Patients aged 6 months to 10 years.
- mono-infection with P. falciparum detected by microscopy;
- parasitaemia of 250 - 200,000/μl asexual forms;
- presence of axillary temperature ≥37.5 °C or history of fever during the past 24 hours
- 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 parents or guardians of children.
Exclusion
- mRDT negative
- presence of general danger signs in children aged 6 months to 10 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1);
- weight under 5 Kg
- mixed or mono-infection with another Plasmodium species detected by microscopy;
- presence of severe malnutrition (defined as a child who has symmetrical oedema involving at least the feet or has a mid-upper arm circumference \< 110 mm in children ≤ 59 months; or BMI of \<16 in children aged 5 years and above)
- 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 medicine(s) being tested or used as alternative treatment(s);
Key Trial Info
Start Date :
July 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2017
Estimated Enrollment :
333 Patients enrolled
Trial Details
Trial ID
NCT03431714
Start Date
July 14 2017
End Date
December 8 2017
Last Update
February 13 2018
Active Locations (1)
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1
National Institute for Medical Research
Tanga, Tanzania