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Trial registered on ANZCTR


Registration number
ACTRN12610000935033
Ethics application status
Approved
Date submitted
28/10/2010
Date registered
3/11/2010
Date last updated
23/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in 3 sentinel sites (LuangPrabang, Khammoune and Attapeu provinces), Lao Peoples’ Democratic Republic
Scientific title
Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in 3 sentinel sites (LuangPrabang, Khammoune and Attapeu provinces), Lao Peoples’ Democratic Republic
Secondary ID [1] 252980 0
None
Universal Trial Number (UTN)
U1111-1117-6432
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
malaria 258558 0
Condition category
Condition code
Infection 258677 258677 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; 25-34kg = 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] 257533 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259575 0
28-day cure rate (ACPR-adequate clinical and parasitological response)
Timepoint [1] 259575 0
during 28 days follow-up per patient
Secondary outcome [1] 266183 0
PCR-corrected ACPR. Polymerase chain reaction (PCR) is a molecular tool/test that will differentiate if the recrudesence is a true failure or a reinfection
Timepoint [1] 266183 0
at the end of study
Secondary outcome [2] 266184 0
Safety. This will be assessed using the case report form questionnaire per patient during treatment and at the end of the 28-day follow-up.
Timepoint [2] 266184 0
During treatment and after 28 days follow-up per patient.

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/u asexual forms;
- presence of axillary temperature = 37.5 degrees C or history of fever during the past 24 hours;
- 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
Gender
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
- Unmarried 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
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
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] 3006 0
Lao People's Democratic Republic
State/province [1] 3006 0
Khammoune
Country [2] 3007 0
Lao People's Democratic Republic
State/province [2] 3007 0
Attapeu
Country [3] 3008 0
Lao People's Democratic Republic
State/province [3] 3008 0
Luang Prabang

Funding & Sponsors
Funding source category [1] 257949 0
Other
Name [1] 257949 0
World Health Organization
Address [1] 257949 0
World Health Organization Western Pacific Regional Office, United Nations Avenue, 1000 Manila
Country [1] 257949 0
Philippines
Funding source category [2] 257950 0
Other
Name [2] 257950 0
Global Funds for Malaria (GFATM) through the Ministry of Health, Lao PDR
Address [2] 257950 0
Ministry of Health, [MOH is the GFATM Primary Recipeint], Chaoanouvong Road, Ban Simeuang, Sisatanak District, Vientaine Capital, Area code (021)
Country [2] 257950 0
Lao People's Democratic Republic
Primary sponsor type
Government body
Name
Ministry of Health
Address
Chaoanouvong Road, Ban Simeuang, Sisatanak District, Vientaine Capital, Area code (021)
Country
Lao People's Democratic Republic
Secondary sponsor category [1] 257150 0
Other
Name [1] 257150 0
Khammoune Provincial Malaria Station
Address [1] 257150 0
Khammoune Province
Anou Road, Ban Laophoxay, Thakert District, Area code (051)
Country [1] 257150 0
Lao People's Democratic Republic
Secondary sponsor category [2] 257182 0
Other
Name [2] 257182 0
Attapue Provincial Malaria Station
Address [2] 257182 0
No.3 Road Ban Xaysaath, Samakixay District, Area code (036)
Country [2] 257182 0
Lao People's Democratic Republic
Secondary sponsor category [3] 257183 0
Other
Name [3] 257183 0
Luang Prabang provincial Malaria Station
Address [3] 257183 0
Sackarin Road, Ban thonchaleune Luangprabang District, Area code (071)
Country [3] 257183 0
Lao People's Democratic Republic
Other collaborator category [1] 251628 0
Hospital
Name [1] 251628 0
Khammoune Provincial Hospital
Address [1] 251628 0
Anou Road, Ban Laophoxay,Thakhert District, Area code (051)
Country [1] 251628 0
Lao People's Democratic Republic
Other collaborator category [2] 251632 0
Hospital
Name [2] 251632 0
Attapue Provincial Hospital
Address [2] 251632 0
No. 3 Road, Ban Meuangmay. Sammakixay District, Area code (036)
Country [2] 251632 0
Lao People's Democratic Republic
Other collaborator category [3] 251633 0
Hospital
Name [3] 251633 0
Luang Prabang Provincial Hospital
Address [3] 251633 0
Nasamphane Road, Ban phoumork Luangprabang District, Area code (071)
Country [3] 251633 0
Lao People's Democratic Republic
Other collaborator category [4] 251634 0
Hospital
Name [4] 251634 0
Chomphet District Hospital
Address [4] 251634 0
No. 4B Road, Ban Chienman, Chomphet District , Area code (071), Luang Prabang
Country [4] 251634 0
Lao People's Democratic Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259960 0
WHO WPRO Ethics Review Committee (ERC)
Ethics committee address [1] 259960 0
WHO Western Pacific Regional Office, United Nations Avenue, 1000 Manila
Ethics committee country [1] 259960 0
Philippines
Date submitted for ethics approval [1] 259960 0
Approval date [1] 259960 0
19/07/2010
Ethics approval number [1] 259960 0
Ethics committee name [2] 259961 0
National Ethics Committee for Health Research (NECHR)
Ethics committee address [2] 259961 0
Ministry of Health
Vientiane
Ethics committee country [2] 259961 0
Lao People's Democratic Republic
Date submitted for ethics approval [2] 259961 0
Approval date [2] 259961 0
04/06/2010
Ethics approval number [2] 259961 0
NECHR/314

Summary
Brief summary
This surveillance study is a one-arm prospective evaluation of the clinical and parasitological responses to directly observed treatment for uncomplicated malaria. The objective is to assess the efficacy and safety of artemether-lumfantrine for the treatment of uncomplicated Plasmodium falciparum malaria in 3 sites Luang Prabang, Khammoune and Attapeu provinces in Lao PDR. The WHO 28-day in vivo protocol will be used. People with uncomplicated falciparum malaria who meet the study inclusion criteria will be enrolled, treated on site with the ACT artemether-lumefantine and monitored weekly for 28 days. The follow-up consists 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. PCR analysis will be used to distinguish between a true recrudescence or reinfection. The results of this study will be used to assist the Ministry of Health of Lao PDR in assessing the current national treatment guidelines for uncomplicated P. falciparum malaria.
Trial website
Trial related presentations / publications
Mekong Malaria III. Towards Malaria Elimination in the Greater Mekong Subregion.
Monitoring Antimalaria Drug Efficacy in the Greater Mekong Subregion; An overview of results from 2008 to 2011. The Southeast Asia Journal of Tropical Medicine and Public Health. Volume 44 (supplement 1) 2013
Public notes

Contacts
Principal investigator
Name 31846 0
Dr Bouasy Hongvanthong
Address 31846 0
Center of Malariology, Parasitology and Entomology
Ministry of Public Health, Vientiane
Country 31846 0
Lao People's Democratic Republic
Phone 31846 0
+856214040
Fax 31846 0
Email 31846 0
hongvanthong@gmail.com
Contact person for public queries
Name 15093 0
Dr Chanthavisouk Chitsavang
Address 15093 0
Office of the WHO Representative in Lao PDR, 125 saphanthong Road unit 5, Ban saphanthong tai, Sisatanak District, Vientaine Capital, Area code (021)
Country 15093 0
Lao People's Democratic Republic
Phone 15093 0
Mobile no: (856) 20 5516966
Fax 15093 0
(856) 21 218131
Email 15093 0
chanthavisoukc@who.int
Contact person for scientific queries
Name 6021 0
Dr Dr Viengxay Vanisaveth
Address 6021 0
Centre of Malariology Parasitology and Entomology
T2 Road, Ban koualuang tai, Chanthabouly District, Vientaine Capital, Area code (021)
Country 6021 0
Lao People's Democratic Republic
Phone 6021 0
(856) 21 214040
Fax 6021 0
(856) 21 218131
Email 6021 0
v.viengxay@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary