Triple Artemisinin-based Combination Therapy for Delaying Drug Resistance Development - a Randomized Clinical Trial

Launched by MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES · Feb 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat uncomplicated malaria caused by a parasite called Plasmodium falciparum. Researchers want to find out if using a combination of three different artemisinin-based treatments, given in a specific order, is more effective than the standard treatment alone. This is important because there are concerns that the malaria parasite may become resistant to current treatments. The trial will involve children aged 6 months to 10 years who have confirmed malaria and meet certain health criteria.

If your child is eligible and participates in the trial, they will receive one of the treatment combinations and will be monitored closely over several weeks to check how well the treatment works and if there are any side effects. The study aims to determine if this new approach can lead to better recovery rates and provide valuable insights into treating malaria more effectively. It's essential for parents or guardians to give consent for their child to join and to ensure that they can attend all scheduled follow-up visits.

Gender

ALL

Eligibility criteria

• • Patients presenting at the health facility with suspected acute uncomplicated malaria will be screened for eligibility.
• Inclusion Criteria:
• • Age from 6 - 120 months
• • Weight ≥ 5 kg
• • Body temperature ≥37.5°C or history of fever in the last 24 hours
• • Microscopy confirmed P. falciparum mono-infection
• • Parasitemia level of 1000-200000/μL
• • Ability to swallow oral medication
• • Ability and willingness to abide by the study protocol and the stipulated follow-up visits
• • A written proxy informed consent from a parent/guardian
• Exclusion Criteria:
• • Children aged below 6 months will not be included in the study because ACTs are contraindicated in this group.
• • Evidence of severe malaria or danger signs
• • Known allergy to trial medicines
• • Reported antimalarial intake ≤2 weeks
• • Haemoglobin \<5 g/dL
• • Blood transfusion within last 90 days
• • Febrile condition other than malaria
• • Known underlying chronic or severe disease (including severe malnutrition).