Efficacy and safety of artemether-lumefantrine, artesunate-amodiaquine and dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria in three provinces in Angola

Not Applicable

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

• Registration Number: ACTRN12615000107527
• Lead Sponsor: Ministry of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. age between 6 months to 9 years;
2. weight greater than or equal to 5 kg;
3. mono-infection with P. falciparum detected by microscopy;
4. parasitaemia of 2000 - 100000 asexual forms per microliter;
5. presence of axillary or tympanic temperature greater than or equal to 37.5 degree centigrade or history of fever during the past 24 h;
6. hemoglobin greater than 5.0g/dl;
7. ability to swallow oral medication;
8. easy access to the health facility and ability/willingness to return to the health facility over the course of the four weeks (six weeks for DP) of follow-up;
9. 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;
2. pneumonia or bronchopneumonia;
3. history of taking antimalarials (or antibiotics with antimalarial activity such as cotrimoxazol, tetracycline or doxycycline) in the last 14 days;
4. mixed or mono-infection with another Plasmodium species detected by microscopy;
5. presence of severe malnutrition defined as a child aged 6-60 months whose weight-for-height is below –3 z-score
6. 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);
7. regular medication, which may interfere with antimalarial pharmacokinetics;
8. 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