Evaluating the effectiveness of artemisinin combination therapy (ACT) in treating malaria in East Africa

Phase 4

Completed

• Conditions: ncomplicated P. falciparum malaria; Infections and Infestations; Uncomplicated Plasmodium falciparum malaria

• Registration Number: ISRCTN63145981
• Lead Sponsor: Rwanda Biomedical Centre

Brief Summary

2019 results in https://doi.org/10.1093/trstmh/trz009

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-05-31
• Study Start: 2020-04-10
• Last Update Posted: 1 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 536

Inclusion Criteria

1. Aged 1 to 14 years
2. A slide-confirmed mono-infection of P. falciparum, asexual parasitemia between 1000 and 100000 p/ul
3. Able to attend follow-up visits
4. Written informed consent provided by parent or guardian. If the
parent/caretaker is illiterate, a witness’ signature and the
thumbprint of the participant’s parent/caretaker will be required.

Exclusion Criteria

1. Severe malnutrition
2. Co-morbidity including but not limited to: infection, severe anaemia, epilepsy, abnormal cardiac rhythm, hypoglycemia, jaundice, respiratory distress, and recent history of allergy,
3. Presence of danger signs including: an inability to drink, vomiting in the past 24 h, an axillary temperature of > 37.5°C or rectal/tympanic temp > 38.0°C, a history of fever within past 24 hours, and/or a recent history of multiple convulsions, unconsciousness, inability to stand or sit

Study & Design

• Study Type: Interventional
• Study Design: Not specified