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Trial registered on ANZCTR


Registration number
ACTRN12618001572257
Ethics application status
Approved
Date submitted
12/09/2018
Date registered
20/09/2018
Date last updated
20/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Salavanh province in Lao PDR.
Scientific title
Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Salavanh province in Lao PDR.
Secondary ID [1] 296026 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 309556 0
Condition category
Condition code
Infection 308378 308378 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single co-formulated drug treatment Standard treatment 6 doses of oral artemether(20mg)-lumefantrine (120mg)/ tablet, given twice a day for 3 days for specific weight groups: 5-14kg=1 tablet twice daily for 3 days; 15-24kg = 2 tablets twice daily for 3 days; 25-34 kg = 3 tablets twice daily for 3 days and 35 kg and above = 4 tablets twice daily for 3 days
The WHO 28 day in vivo protocol used in this study consists of parasite count and temperature
measurements at baseline ( day 0 before dosing) and on days 1,2,3,7,14,21,28
Intervention code [1] 312362 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307357 0
Proportion of treatment success confirmed by using blood smears for microscopy and dry blood spot for Polymerase Chain-Reaction (PCR).
Timepoint [1] 307357 0
28 days after treatment is the primary timepoint. Patients will be assessed daily on Day 0, 1, 2 and 3, and weekly thereafter (D7, D14, D21) until Day 28.
Secondary outcome [1] 351594 0
Evaluate safety by the incidence of adverse events assessed by clinical observation of symptoms. For example: vomiting, abdominal pain, and rashes.
Timepoint [1] 351594 0
Any time adverse events occur between Day 0 and Day 28.

Eligibility
Key inclusion criteria
- age between 6 months and above;
- mono-infection with P. falciparum detected by microscopy;
- P. falciparum parasitaemia of 250-100.000/µl asexual forms;
- presence of axillary temperature = 37.5 °C or history of fever during the past 24 h;
- ability to swallow oral medication;
- ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
- Informed consent from the patient or from a parent or guardian in the case of children.
Minimum age
6 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO
- mixed or mono-infection with another Plasmodium species detected by microscopy;
- presence of severe malnutrition (defined as a child whose growth standard is below –3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 110 mm);
- presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
-regular medication, which may interfere with antimalarial pharmacokinetics;
- history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); and
- Women age 12-18 years old
- a positive pregnancy test or lactating
- Unable to or unwilling to take contraceptives for pregnancy negative married women of child- bearing age.

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)
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
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/04/2017
Date of last participant enrolment
Anticipated
Actual
13/09/2017
Date of last data collection
Anticipated
Actual
17/10/2017
Sample size
Target
50
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 20829 0
Lao People's Democratic Republic
State/province [1] 20829 0
Salavanh Province

Funding & Sponsors
Funding source category [1] 300616 0
Other
Name [1] 300616 0
World Health Organization
Country [1] 300616 0
Lao People's Democratic Republic
Primary sponsor type
Government body
Name
Ministry of Health
Address
Samsanthai road, Ban thatkhao, Sisattanak district, Vientiane Capital.
Country
Lao People's Democratic Republic
Secondary sponsor category [1] 300121 0
None
Name [1] 300121 0
Address [1] 300121 0
Country [1] 300121 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301404 0
National Ethics Committee for Health Research
Ethics committee address [1] 301404 0
Samsenthai road, Ban Khaoyot, Sisattanak district, vientiane capital
Ethics committee country [1] 301404 0
Lao People's Democratic Republic
Date submitted for ethics approval [1] 301404 0
02/05/2016
Approval date [1] 301404 0
08/06/2016
Ethics approval number [1] 301404 0
105/NIOPH
Ethics committee name [2] 301408 0
WHO Ethics Research Committee
Ethics committee address [2] 301408 0
WHO Western Pacific Regional Office, United Nations Ave, Ermita, Manila, 1000 Metro Manila, Philippines
Ethics committee country [2] 301408 0
Philippines
Date submitted for ethics approval [2] 301408 0
12/06/2016
Approval date [2] 301408 0
12/07/2016
Ethics approval number [2] 301408 0
2016.12.LAO.1.MVP

Summary
Brief summary
This surveillance study is a one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria. , People with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with the ACT artemether-lumefantine for uncomplicated P. falciparum malaria and monitored for 28 days. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. On the basis of the results of these assessments, the patients will be classified as having therapeutic failure (early or late) or an adequate response. The proportion of patients experiencing therapeutic failure during the follow-up period will be used to estimate the efficacy of the study drug(s). PCR analysis will be used to distinguish between a true recrudescence due to treatment failure and episodes of reinfection.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86886 0
Dr Bouasy Hongvanthong
Address 86886 0
Center of Malariology, Parasitology and Entomology
Nongdouang raod, Ban khoualuang tai, Chanthabouly district, Vientiane capital
Country 86886 0
Lao People's Democratic Republic
Phone 86886 0
+856 21 214040
Fax 86886 0
+ 856 21 218131
Email 86886 0
[email protected]
Contact person for public queries
Name 86887 0
Dr Vienxay Vanisaveth
Address 86887 0
Center of Malariology, Parasitology and Entomology
Nongdouang raod, Ban khoualuang tai, Chanthabouly district, Vientiane capital
Country 86887 0
Lao People's Democratic Republic
Phone 86887 0
+ 856 21 214040
Fax 86887 0
+ 856 21 218131
Email 86887 0
[email protected]
Contact person for scientific queries
Name 86888 0
Dr vonethalom Thongpaseut
Address 86888 0
Center of Malariology, Parasitology and Entomology
Nongdouang raod, Ban khoualuang tai, Chanthabouly district, Vientiane capital
Country 86888 0
Lao People's Democratic Republic
Phone 86888 0
+856 21 214040
Fax 86888 0
+ 856 21 218131
Email 86888 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.