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Trial registered on ANZCTR


Registration number
ACTRN12615000748516
Ethics application status
Approved
Date submitted
12/04/2015
Date registered
20/07/2015
Date last updated
20/07/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy study of artemether-lumefantrine for the treatment of malaria in Solomon Islands.
Scientific title
Efficacy study of artemether-lumefantrine for the treatment of Plasmodium falciparum (P. falciparum or Pf) and Plasmodium vivax (P. vivax or Pv) in Solomon Islands.
Secondary ID [1] 286514 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria infection 294729 0
Condition category
Condition code
Infection 295018 295018 0 0
Other infectious diseases
Public Health 295280 295280 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with a microscopically confirmed P. falciparum or P. vivax infection on day 0 will be administered a fixed dose combination of artemether (20 mg) and lumefantrine (120 mg) (CoartemTM, Novartis) as a six-dose regimen twice a day for three days according to body weight under direct supervision by the study team. The mode of administration is oral dosing as follows: 5 to <15 kg bodyweight: 1 tablet per dose; 15 to <25 kg: 2 tablets per dose; 25 to <35 kg: 3 tablets per dose; =35 kg: 4 tablets per dose. In addition, the Pv group will also receive oral primaquine once daily for 14 days (0.25 mg base/kg/day), starting on Day 28 after completion of the 28-day follow-up. The study patients will be observed for 30 min after drug administration for adverse reactions or vomiting. Any patient who vomited during this observation period will be re-treated with the same dose of AL and observed for an additional 30 min. Patients are requested to return to the clinic on days 1, 2, 3, 7, 14, 21 and 28 for clinical and parasitological assessment as per protocol follow up schedule, or whenever they did not feel well.
Intervention code [1] 291605 0
Treatment: Drugs
Intervention code [2] 292289 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294773 0
Primary Outcome 1: To assess the therapeutic efficacy of artemether-lumefantrine (AL, Coartem Trademark) combination therapy for the treatment of uncomplicated Plasmodium falciparum and P. vivax infections in an area of Solomon Islands. The efficacy of AL in the two groups are compared by the number of patients cured of their infection over a 28-day follow-up period. Recrudescence of infection will be determined by Polymerase Chain Reaction (PCR) analysis. Early treatment failure (ETF), late parasitological failure (LPF), late clinical failure (LCF) and late parasitological failure (LPF) as defined in WHO (2003: Assessment and monitoring of antimalarial drug efficacy for the treatment of uncomplicated falciparum malaria. Geneva: World Health Organization. 68 pp). Note: Primaquine was administered after Day 28, hence the effect of artemether-lumefantrine combination therapy was solely evaluated in this group.
Timepoint [1] 294773 0
Absence of parasitaemia on day 28 irrespective of axillary temperature without previously meeting any of the criteria of Early Treatment Failure (ETF) or Late Clinical Failure (LCF) or Late Parasitological Failure (LTF).
Secondary outcome [1] 314017 0
Safety
Timepoint [1] 314017 0
Absence of side effects up to 28 days post-treatment
All patients will be asked about old symptoms and new symptoms emerging since previous visit during the follow-up. Known possible side effects include stomach cramps, nausea, vomiting and diarrhoea. Where clinically indicated patients will be evaluate and treated appropriately. All adverse events will be recorded on the case reporting form. For a patient who vomits twice, the patient will be withdrawn from the study and he/she will given rescue treatment.

Eligibility
Key inclusion criteria
(i) Sex: male or female
(ii) Age: between 1 year and 65 years old
(iii) Falciparum or vivax infection with parasitemia between 500 and 100,000 parasites/ul of blood
(iv) History of fever during 48 hours prior to time of recruitment
(v) Ability to swallow oral medication
(vi) Is willing to give small amounts of blood via finger prick
(vii) Written informed consent from the patient or parent/guardian (in the case of young children), assent from child (ages 8-17 years inclusive).
(viii) Written informed consent and agreed to treatment follow-up for a total of 28 days
(ix) Willingness on the part of the patient to return to the clinic for scheduled check-ups during the 28-day follow-up period
Minimum age
1 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Severe/cerebral malaria or history of another serious medical disease
(ii) Prior treatment with an artemisinin or another antimalarial drug within the previous 7 days
(iii) Pregnancy and lactating
(iv) Inability to communicate well with the investigator (poor mental development or evidence of psychiatric disorder)
(v) Are likely to be absent from the household during the study period.
(vi) Chronic infectious diseases other than malaria (e.g. tuberculosis)
(vii) Known allergy and/or intolerance to drug(s) being tested

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of drugs was not concealed. Patients were sequentially enrolled and given treatment: CoArtem (a fixed dose combination of artemether (20 mg) and lumefantrine (120 mg) as a six-dose regimen twice a day for three days. For the P. vivax group, patients were administered primaquine daily for 14 days at the presecribed dose according to body weight after Day 28.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Both Pf and Pv group of patients received 3-day artemether-lumefantrine. But the Pv group received an additional oral primaquine once daily for 14 days (0.25 mg base/kg/day), starting on Day28 after completion of the 28-day follow-up.
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Assuming an expected treatment failure rate of 5% with artemether-lumefantrine, a power of 80%, and a 5% level of significance, 59 subjects will need to be enrolled in each of the Pf or Pv group. A 15% drop-out (or loss to follow-up) can be expected during a 28-day study, so a total of 70 patients should be enrolled in each of the Pf or Pv group

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/05/2008
Actual
30/06/2008
Date of last participant enrolment
Anticipated
11/11/2008
Actual
8/10/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment outside Australia
Country [1] 6804 0
Solomon Islands
State/province [1] 6804 0
Malaita Province

Funding & Sponsors
Funding source category [1] 291080 0
Other
Name [1] 291080 0
World Health Organization
Country [1] 291080 0
Philippines
Primary sponsor type
Government body
Name
Ministry of Health
Address
Vector Borne Disease Control Program Tongs Building, Hibiscus Avenue,, Honiara
Country
Solomon Islands
Secondary sponsor category [1] 289757 0
None
Name [1] 289757 0
Address [1] 289757 0
Country [1] 289757 0
Other collaborator category [1] 278431 0
Government body
Name [1] 278431 0
Australian Malaria Institute
Address [1] 278431 0
Weary Dunlop Drive, Gallipoli Barracks, Enoggera, Qld 4208.
Country [1] 278431 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292663 0
National Health Research Ethics Committee, Solomon Islands
Ethics committee address [1] 292663 0
Ethics committee country [1] 292663 0
Solomon Islands
Date submitted for ethics approval [1] 292663 0
Approval date [1] 292663 0
23/11/2006
Ethics approval number [1] 292663 0
0706

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56442 0
Dr Lyndes Wini
Address 56442 0
Locked Bag, National Vector Borne Diseases Control Program, Ministry of Health and Medical Services, Honiara, Solomon Islands
Country 56442 0
Solomon Islands
Phone 56442 0
+67739748
Fax 56442 0
+67738022
Email 56442 0
lyndes.wini@gmail.com
Contact person for public queries
Name 56443 0
Jeffrey Hii
Address 56443 0
Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvidhi Rd, Bangkok 10400
Country 56443 0
Thailand
Phone 56443 0
+66 (0)9 03025573
Fax 56443 0
+66 (0) 2354 5629
Email 56443 0
hiijk1@gmail.com
Contact person for scientific queries
Name 56444 0
Jeffrey Hii
Address 56444 0
Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvidhi Rd, Bangkok 10400
Country 56444 0
Thailand
Phone 56444 0
+66 (0)9 03025573
Fax 56444 0
+66 (0) 2354 5629
Email 56444 0
hiijk1@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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