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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 14 July 2014
Main ID:  ISRCTN40020296
Date of registration: 09/10/2008
Primary sponsor: Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Public title: A phase IV randomised study to assess the tolerability of artesunate-amodiaquine (AS-AQ) (Winthrop® fixed dose combination [FDC]) and artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in Liberia N/A
Scientific title:
Date of first enrolment: Sep 29 2008
Target sample size: 1000 patients
Recruitment status: Completed/Not recruiting
URL:  http://isrctn.org/ISRCTN40020296
Study type:  Interventional
Study design:  A randomised, single-blind, two-armed, single-centre comparative study  
Countries of recruitment
Contacts
Key inclusion & exclusion criteria
Inclusion criteria: 1. Aged greater than or equal to 6 years, either sex
2. Weight greater than or equal to 18 kg
3. Symptoms of malaria defined as fever (axillary temperature greater than or equal to 37.5°C), or history of fever in previous 48 hours
4. Microscopic confirmation of asexual stages of P. falciparum or mixed infection
5. Willingness to attend for follow-up
6. Signed informed consent by patient or responsible caregiver

Exclusion criteria: 1. Pregnancy (pregnancy test to be performed in women of childbearing age)
2. Severe malaria
3. AS-AQ or AL treatment at appropriate dose or more than two doses of another antimalarial in the previous 4 weeks
4. Known hypersensitivity to artemisinin derivates or amodiaquine, or artemether-lumefantrine
5. Severe anaemia (less than 5 g/dl haemoglobin)
6. Concomitant febrile illness if additional medication is required other than antipyretics


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Malaria
Intervention(s)
Patients will be equally randomised into the following treatment groups:
1. Artesunate-amodiaquine (AS-AQ Winthrop®, Sanofi-Aventis): tablet strength AS/AQ 100/270 mg. Participants will be dosed according to body weight:
18 - 35.9 kg = 1 x 100/270 mg tablet once daily
Greater than 36 kg = 2 x 100/270 mg tablets once daily
2. Artemether-lumefantrine (Coartem, Novartis): tablet strength A/L 20/120 mg. Participants will be dosed according to body weight:
15 - 24.9 kg = 2 x 20/120 mg tablets twice daily, 8 - 12 hour between dosages
25 - 34.9 kg = 3 x 20/120 mg tablets twice daily, 8 - 12 hour between dosages
Greater than 35 kg = 4 x 20/120 mg tablets twice daily, 8 - 12 hour between dosages

For both arms: 3 days of treatment + 25 follow-up days (study duration/patient = 28 days).
Primary Outcome(s)
To describe clinical tolerability of a fixed dose of AS-AQ (Winthrop® FDC) in adults and children over 6 years with uncomplicated P. falciparum malaria compared to a non-AQ containing reference therapy, i.e. artemether-lumefantrine. The clinical tolerability will be defined as the occurrence of most common adverse events.
Secondary Outcome(s)
1. To describe serious adverse and drug related adverse events occurring within 1 month of drug administration for both treatment
2. To assess efficacy of treatment at 28 days (polymerase chain reaction [PCR] genotyping corrected)
3. To describe day 0 and day 7 blood levels of desethyl-amodiaquine and lumefantrine
Secondary ID(s)
7071
Source(s) of Monetary Support
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Secondary Sponsor(s)
N/A
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