Efficacy and safety of artemisinin-based combinations: artesunate+amodiaquine and artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum in the sites of BUHIGA, KAZIRABAGENI and KIGOBE MUTOYI in KARUZI , MAKAMBA, BUJUMBURA MAIRIE et GITEGA provinces, respectively, BURUNDI

Phase 4

Withdrawn

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

• Registration Number: ACTRN12616001006437
• Lead Sponsor: Ministry of Health of Burundi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 528

Inclusion Criteria

1. age between 6 and 120 months;
2. mono-infection with P. falciparum detected by microscopy;
3. parasitaemia of 1000 - 200000/mocroliter asexual forms;
4. presence of axillary temperature greater than or equal 37.5 degrees 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 parent or guardian;

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 (Appendix 1);
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);

Study & Design

• Study Type: Interventional
• Study Design: Not specified