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Trial registered on ANZCTR


Registration number
ACTRN12613000408785
Ethics application status
Approved
Date submitted
4/04/2013
Date registered
15/04/2013
Date last updated
15/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Artemether-Lumefantrine and Amodiaquine-Artesunate for treatment of Uncomplicated Malaria in Children in Uganda
Scientific title
Efficacy of Artemether-Lumefantrine and Amodiaquine-Artesunate for treatment of Uncomplicated Malaria in Children in Uganda
Secondary ID [1] 282316 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uncomplicated falciparum malaria in children 288761 0
Condition category
Condition code
Infection 289120 289120 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
artemether-lumefantrine in fixed combination tablet each containing 20 mg of artemethr and 120 mg lumefantrine. Tablets will be given twice daily for three consecutive days. The number of tablets per dose is according to body weight. Children between 5 and 14 kg body weight will receive 1 tablet, between 15 and 24 kg, two tablets, between 25 and 34 kg, 3 tablets, and over 35 kg 4 tablets per dose. This dosing regimen is as per natioanl policy for this indication.
Intervention code [1] 286855 0
Treatment: Drugs
Comparator / control treatment
artesunate-amodiaquine co-formulated in 3 tablet strengths based on body wight will be adminstered once a day for thre days. Children who weigh between 5 and 9 kg will receive 1 tablet containing artesunate 25 mg /amodiaquine 67.5 mg; children between 9 and 18 kg body weight will receive 1 tablet conatianing artesunate 50 mg/amodiaquine 35 mg; and children between 18 and 36 kg body weight will receive 1 tablet containing artesunate 100 mg/amodiaquine 270 mg once daily for three consecutive days. This dosing regimen is as per national policy for this indication.
Control group
Active

Outcomes
Primary outcome [1] 289232 0
Risk of treatment failure unadjusted and adjusted by genotyping at day 28
Timepoint [1] 289232 0
Day 28
Secondary outcome [1] 302077 0
Incidence of adverse events of moderate or greater severity, at least possibly related to study medications, excluding patients requiring quinine therapy, as reported by patients or observed by investigators. Clinical laboratory studies may be required to confirm a diagnosis or to follow-up an adverse event
Timepoint [1] 302077 0
Days 1,2,3, 7, 14, 21 and 28 or day of treatment failure

Eligibility
Key inclusion criteria
Age 6-59 months
Uncomplicated malaria due to P. falciparum mono-infection with parasite density between 2000 and 200,000 /microliter of blood
Fever ( > 37.5 degrees Celsius axillary) or history of fever in the previous 24 hours
Provision of informed consent and ability to participate in 28-day follow-up (patient has easy access to health unit)
Not previously enrolled in this study
Minimum age
6 Months
Maximum age
59 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Weight less than 5 kg
History of serius side effects to study medications
Concomitnt febrile illness in addition to malaria
Danger and signs or evidence of severe malaria
Severe malnutiriton
Regular medication which may interfere with the antimalarial pharmacokinetic
History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study subjects will be screened from the outpatient department of the sentinel health centers. Eligible subjects will be randomly assigned to receiving either artemether-lumefantrine or amodiaquine-artesunate. Computer generated randomization lists will be created for each of the 3 sentinel site and sent in a sealed envelope to the study nurse of each site. Only study nurse will have access to the randomization list. To allocate subjects to the appropriate treatment group, the study nurse will select the next available number and corresponding study drug.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4972 0
Uganda
State/province [1] 4972 0

Funding & Sponsors
Funding source category [1] 287009 0
Government body
Name [1] 287009 0
Uganda Ministry of Health and Uganda Malaria Surveillance Project Drug Efficacy
Address [1] 287009 0
Uganda Natioanl Malaria Control Program, Ministry of Health
C/O Seraphine Adibaku
Box 7272
Kampala
Uganda
Country [1] 287009 0
Uganda
Funding source category [2] 287010 0
Other
Name [2] 287010 0
World Health Organization
Address [2] 287010 0
20 avenue Appia
CH 1211
Geneva 27
Switzerland
Country [2] 287010 0
Switzerland
Primary sponsor type
Government body
Name
Uganda National Malaria COntrol Program, Ministry of Health
Address
C/O Seraphine Adibaku
Box 7272
Kampala
Uganda

Country
Uganda
Secondary sponsor category [1] 285793 0
Other
Name [1] 285793 0
Uganda Malaria Surveillance Project (UMSP)/ Infectious Diseases Research Collaboration (IDRC)
Address [1] 285793 0
Catherine Tugaineyo
P.O. Box 7475
Kampala
Uganda

Country [1] 285793 0
Uganda
Other collaborator category [1] 277348 0
University
Name [1] 277348 0
Moses Kamya
Makerere University College of Health Sciences, School of Medicine
Address [1] 277348 0
Box 7062
Kampala
Uganda

Country [1] 277348 0
Uganda
Other collaborator category [2] 277349 0
University
Name [2] 277349 0
University of California San Francisco (UCSF)
Peter/Padilla/Tamara Clark
Address [2] 277349 0
San Francisco General Hospital
1001 Potrero Avenue
San Francisco, CA 94110, USA

Country [2] 277349 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289050 0
WHO ERC
Ethics committee address [1] 289050 0
20, avenue Appia
CH1211 Genva 27
Switzerland
Ethics committee country [1] 289050 0
Switzerland
Date submitted for ethics approval [1] 289050 0
Approval date [1] 289050 0
27/03/2013
Ethics approval number [1] 289050 0
RPC559

Summary
Brief summary
To estimate the clinical and parasitological efficacy of two artemisinin-based combination therapies (artemether-lumefantrine and artesunate-amodiaquine) included in the national policy for the treatment of uncomplicated falciparum malaria in children. The study will be conducted in three Uganda Malaria Surveillance Project sentinel sites. The results will be used to formulate recommendations enabling the Ministy of Health to make decisions about the possible need for updating the current national antimalarial treatment policy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38982 0
Prof Mosses Kamya
Address 38982 0
Director Infectious Disease Research Collaboration/
Uganda Malaria Surveillance Project
Box 7475
Kampala
Uganda

Country 38982 0
Uganda
Phone 38982 0
+256 414 53 06 92
Fax 38982 0
Email 38982 0
mkamya@infocom.co.ug
Contact person for public queries
Name 38983 0
Ms Catherine Tugaineyo
Address 38983 0
Uganda Malaria Surveillance Project
Box 7475
Kampala
Uganda
Country 38983 0
Uganda
Phone 38983 0
+256 414 53 06 92
Fax 38983 0
Email 38983 0
ctugaineyo@muucsf.org
Contact person for scientific queries
Name 38984 0
Ms Catherine Tugaineyo
Address 38984 0
Uganda Malaria Surveillance Project
Box 7475
Kampala
Uganda
Country 38984 0
Uganda
Phone 38984 0
+256 414 53 06 92
Fax 38984 0
Email 38984 0
ctugaineyo@muucsf.org

No information has been provided regarding IPD availability
Summary results
No Results