Efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum in health units of the Agua Grande and Lobata districts of the Sao Tome Island, Sao Tome and Principe

Phase 4

Not yet recruiting

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

• Registration Number: ACTRN12616001609448
• Lead Sponsor: Ministry of Health of Sao Tome and Principe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-21
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

1. age from 6 months to 60 years;
2. mono-infection with P. falciparum detected by microscopy;
3. parasitaemia of 500–100,000/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 the patient or parent/ guardian of children.
8. informed assent from any minor participant aged from 12 to age of majority years; and
9. consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under the age of majority years.

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. weight under 5 kg;
3. Haemoglobin < 8g/dl;
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 has a mid-upper arm circumference below 115 mm)
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);
9. a positive pregnancy test or breastfeeding; and
10. unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age and who are sexually active.

Study & Design

• Study Type: Interventional
• Study Design: Not specified