ICTRP Search Portal

Main

Note: This record shows only 22 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:	24 April 2017
Main ID:	ISRCTN51688713
Date of registration:	09/10/2008
Prospective Registration:	Yes
Primary sponsor:	Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Public title:	Efficacy of amodiaquine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Nimba county, Liberia
Scientific title:	Efficacy of amodiaquine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Nimba county, Liberia
Date of first enrolment:	17/11/2008
Target sample size:	300
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN51688713
Study type:	Interventional
Study design:	Randomised single-blind two-armed single-centre comparative study (Treatment)
Phase:	Not Applicable

Countries of recruitment
Liberia

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Richard Smith
Address:	Saclepea CHC - Nimba county Liberia
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: 1. Age group of 6 and 59 months, either sex
2. Weight greater than or equal to 5 kg
3. Slide-confirmed infection with Plasmodium falciparum only (no mixed infections)
4. Asexual parasite density between 2,000 and 200,000/µl of blood, and
5. Measured axillary temperature greater than or equal to 37.5°C or history of fever in the last 48 hours, and
6. High probability of respecting the follow-up visits (residence within 1 hour walking distance from the OPD, no upcoming travel plans, etc.), and
7. Informed consent from a parent or guardian aged at least 18 years
Exclusion criteria: 1. General danger signs according to the World Health Organization (WHO) definition
2. Signs of severe/complicated malaria according to the WHO definition
3. Severe anaemia (haemoglobin less than 5 g/dL)
4. Known history of hypersensitivity to any of the study drugs
5. Severe malnutrition (as defined by a weight-for-height below 70% of median and/or symmetrical oedemas involving at least the feet)
6. Concomitant febrile illness judged as due to causes other than malaria with the potential to confound study outcome (measles, acute lower tract respiratory infection, otitis media, tonsillitis, abscesses, severe diarrhoea with dehydration, etc; mild flu shouldn't lead to exclusion)
7. Having received already a full course of the treatment (or one of the treatments) under study in the previous 10 days

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria
Infections and Infestations
Plasmodium falciparum malaria

Intervention(s)

Patients will be equally randomised into the following treatment groups:
1. Artesunate-amodiaquine fixed dose combination (AS/AQ FDC) (artesunate amodiaquine Winthrop® Sanofi Aventis):
1.1. Artesunate 25 mg/amodiaquine 67.5 mg 1 tablet/day for 3 days in children 5 kg to 8.9 kg
1.2. Artesunate 50 mg/amodiaquine 135 mg 1 tablet/day for 3 days in children 9 kg to 17.9 kg
1.3. Artesunate 100 mg/amodiaquine 270 mg 1 tablet/day for 3 days in children 18 kg to 35.9 kg
2. Coartem®: artemether 20 mg - lumefantrine 120 mg co-formulated tabs (Coartem®, Novartis) given as six twice-daily doses over three days:
2.1. One tablet/dose for weight 5 - 14.9 kg (total 6 tablets)
2.2. Two tablets/dose for weight 15 - 24.9 kg (total 12 tablets)
2.3. Three tablets/dose for weight 25 - 34.9 kg (total 18 tablets)
2.4. Four tablets/dose for weight greater than or equal to 35 kg (total 24 tablets)
The second dose will be given 8 to 12 hours after the first dose, given at inclusion. Patients will be given milk, or encouraged to breastfeed, before each dose is taken.

For both arms: 3 days of treatment + 39 follow-up days (study duration/patient = 42 days).

Primary Outcome(s)

1. To evaluate the efficacy of both drugs uncorrected by PCR genotyping at day 42 and to compare the re-infection rates
2. To evaluate the PCR corrected and uncorrected efficacy of amodiaquine-artesunate and artemether-lumefantrine on day 28 of follow up

Secondary Outcome(s)

1. To assess the safety of amodiaquine-artesunate and artemether-lumefantrine treatment among children between 6 and 59 months old suffering from uncomplicated malaria by documenting adverse events that occurred during the study, before:
1.1. Day 28
1.2. Day 42
1.3. By documenting serious adverse events (SAE)
2. To assess inter patient absorption differences possibly influencing efficacy by measuring the pharmacokinetic (PK) of amodiaquine and lumefantrine at day 0 and day 7

Secondary ID(s)

7070

Source(s) of Monetary Support

Drugs for Neglected Diseases initiative (DNDi) (Switzerland)

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.