Status:
COMPLETED
Study to Compare the Triple ACT AL+AQ With the ACT AL in Cambodia and Vietnam
Lead Sponsor:
University of Oxford
Conditions:
Malaria, Falciparum
Eligibility:
All Genders
2-65 years
Phase:
PHASE3
Brief Summary
This study is a multi-centre, open-label randomised trial to assess the efficacy, safety and tolerability of the Triple ACT artemether-lumefantrine+amodiaquine (AL+AQ) compared to the ACT artemether-l...
Detailed Description
"The study of artemether-lumefantrine or artemether-lumefantrine combined with amodiaquine will be a two-arm randomized open label comparative study. The main activity proposed is a series of detaile...
Eligibility Criteria
Inclusion
- Male or female, aged from 2 years to 65 years old
- Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum (or mixed with non-falciparum species)
- Asexual P. falciparum parasitaemia: 16 to 200,000/microlitre, determined on a thin or thick blood film
- Fever defined as \> 37.5°C tympanic temperature or a history of fever within the last 24 hours
- Written informed consent (by parent/guardian in case of children)
- Willingness and ability of the patients or parents/guardians to comply with the study protocol for the duration of the study
Exclusion
- Signs of severe/complicated malaria
- Haematocrit \< 25% or Hb \< 8 g/dL at screening
- Acute illness other than malaria requiring treatment
- For females: pregnancy, breast feeding
- Patients who have received artemisinin or a derivative or an artemisinin-containing combination therapy (ACT) within the previous 7 days
- History of allergy or known contraindication to artemisinins, lumefantrine or amodiaquine
- Previous splenectomy
- corrected QT interval \> 450 milliseconds at moment of presentation
- Documented or claimed history of cardiac conduction problems
- Previous participation in the current study or another study in the previous 3 months
Key Trial Info
Start Date :
March 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2020
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT03355664
Start Date
March 19 2018
End Date
March 4 2020
Last Update
July 15 2022
Active Locations (4)
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1
Siem Pang Health Center
Siem Pang, Stung Treng, Cambodia, 1803
2
Pailin Referral Hospital
Pailin, Cambodia, 2401
3
Hospital for Tropical Diseases of Khanh Hoa,
Vạn Giã, Khanh Hoa, Vietnam
4
Phuoc Long Hospital
Phước Long, Phuoc, Vietnam