Efficacy and safety of artesunate in treatment of malaria caused by Plasmodium falciparum parasite in Guyana

Phase 4

Completed

• Conditions: Malaria; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12616000526471
• Lead Sponsor: Regional Office for the Americas of the World Health Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. age greater or equal to 2 years;
2. mono-infection with P. falciparum detected by microscopy;
3. parasitaemia of 1000–100,000/microliter asexual forms;
4. presence of axillary temperature greater or equal to 37.5 degrees C 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 patients or parent or guardian of children.

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. mixed or mono-infection with another Plasmodium species detected by microscopy;
3. presence of severe malnutrition defined as a child aged 6-60 months has a mid-upper arm circumference belo 115 mm)
4. 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);
5. regular medication, which may interfere with antimalarial
pharmacokinetics;
6. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
7. a positive pregnancy test or breastfeeding (include this criterion only if adults are included);
8. unable to or unwilling to take a pregnancy test or contraceptives (for women of child-bearing age);
9. previous antimalarial drug intake in the past 48 hours;
10. Patients presenting with splenectomy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified