Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001650280
Ethics application status
Approved
Date submitted
20/09/2018
Date registered
5/10/2018
Date last updated
5/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of the combination dihydroartemisinin-piperaquine (DHA-PIP) for the treatment of uncomplicated Plasmodium falciparum malaria in Champasack province, Laos PDR
Scientific title
Efficacy and safety of the combination dihydroartemisinin-piperaquine (DHA-PIP) for the treatment of uncomplicated Plasmodium falciparum malaria in Champasack province, Laos PDR
Secondary ID [1] 296147 0
None
Universal Trial Number (UTN)
None
Trial acronym
TES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 309733 0
Condition category
Condition code
Infection 308540 308540 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral tablets of drug contains DHA 40mg – PIP 320 mg will be administered at a dose of expressed as milligram base per kilogram body weight, one daily doses per day for three days.
5kg-9kg = 1/2 tablet once daily for 3 days
10kg- 19kg = 1 tablet once daily for 3 days
20kg-29kg = 1,1/2 tablet once daily for 3 days
30 kg - 39 kg = 2 tablets once daily for 3 days
40 kg- > 60kg = 3 tablets once daily for 3 days

All doses of medicine will be administered under the supervision of a qualified member of staff designated by the principal investigator.
Intervention code [1] 312474 0
Treatment: Drugs
Comparator / control treatment
No control groups
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307516 0
The proportion of treatment success confirmed by using blood smears for microscopy and dry blood spot for Polymerase Chain-Reaction (PCR). For the purposes of this study, treatment success is defined as patients who have an adequate clinical and parasitological response to treatment.
Timepoint [1] 307516 0
42 days after treatment the primary timepoint patients will be assessed daily on Day0,1,2 and 3 and weekly thereafter ( D7,D14,D21,D28,D35) until Day 42
Secondary outcome [1] 352158 0
Evaluate safety by the incidence of adverse events assessed by clinical observation of symptoms. For example: vomiting, abdominal pain, and rashes
Timepoint [1] 352158 0
Any time adverse events occur between Day 0 and Day 7

Eligibility
Key inclusion criteria
- Age between 5 months and above to 60 years old as maximum age;
- P. falciparum confirmed by microscopy;
- P. Falciparum parasitaemia of 1000-100,000/µl asexual forms;
- Presence of axillary temperature more than 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;
- Informed consent from the patient or from a parent or guardian in the case of children aged less than 12 year old;
- Informed assent from any minor participant aged more than 12 years and less than 18 years old ;
- Consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under 18 years.
Minimum age
5 Months
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- presence of general danger signs in children aged under 5 months or signs of severe falciparum malaria according to the definitions of WHO
- weight under 5 kg;
- 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 < 115 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);
- Female patients of child-bearing age, defined as those who menstruate and who are sexually active, will be not included in the study, because they are always not honest to tell on their sexual intercourse experience, which also reflects local culture if they are not yet married.
- a positive pregnancy tested or lactating women; and
- Unable to or unwilling to take pregnancy test or to use contraception for women of child- bearing age and who are sexually active.

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)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
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
As the treatment failure rate to the DHA-PIP in the area is unknown, 5% has been chosen. At a confidence level of 95% and a precision around the estimate of 5%, a minimum of 50 patients must be included. With a 20% increase to allow loss to follow-up and withdrawals during the 42-day follow-up period, 100 patients should be included in the study for p.falciparum.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/09/2016
Date of last participant enrolment
Anticipated
Actual
31/08/2017
Date of last data collection
Anticipated
Actual
15/10/2017
Sample size
Target
100
Accrual to date
Final
42
Recruitment outside Australia
Country [1] 20857 0
Lao People's Democratic Republic
State/province [1] 20857 0
Champasack province

Funding & Sponsors
Funding source category [1] 300733 0
Other
Name [1] 300733 0
World Health Organization
Country [1] 300733 0
Lao People's Democratic Republic
Funding source category [2] 300734 0
Government body
Name [2] 300734 0
Ministry of Health
Country [2] 300734 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] 300271 0
None
Name [1] 300271 0
Address [1] 300271 0
Country [1] 300271 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301512 0
National Ethics Committee for Health Research
Ethics committee address [1] 301512 0
Samsenthai road, Ban Khaoyot, Sisattanak district, vientiane capital
Ethics committee country [1] 301512 0
Lao People's Democratic Republic
Date submitted for ethics approval [1] 301512 0
02/05/2016
Approval date [1] 301512 0
08/06/2016
Ethics approval number [1] 301512 0
106/NIOPH

Summary
Brief summary
This 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 drug combination DHA-PIP, and monitored for 42 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 as having an adequate clinical and parasitological 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 due to treatment failure and episodes of reinfection.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87254 0
Dr Bouasy Hongvanthong
Address 87254 0
Center of Malariology, Parasitology and Entomology
Nongdouang raod, Ban khoualuang tai, Chanthabouly district, Vientiane capital
Country 87254 0
Lao People's Democratic Republic
Phone 87254 0
+856 21 214040
Fax 87254 0
+ 856 21 218131
Email 87254 0
[email protected]
Contact person for public queries
Name 87255 0
Vienxay Vanisaveth
Address 87255 0
Center of Malariology, Parasitology and Entomology
Nongdouang raod, Ban khoualuang tai, Chanthabouly district, Vientiane capital
Country 87255 0
Lao People's Democratic Republic
Phone 87255 0
+ 856 21 214040
Fax 87255 0
+ 856 21 218131
Email 87255 0
[email protected]
Contact person for scientific queries
Name 87256 0
vonethalom Thongpaseut
Address 87256 0
Center of Malariology, Parasitology and Entomology
Nongdouang raod, Ban khoualuang tai, Chanthabouly district, Vientiane capital
Country 87256 0
Lao People's Democratic Republic
Phone 87256 0
+856 21 214040
Fax 87256 0
+ 856 21 218131
Email 87256 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
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