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Trial registered on ANZCTR


Registration number
ACTRN12611000175976
Ethics application status
Approved
Date submitted
8/01/2011
Date registered
15/02/2011
Date last updated
16/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of artesunate and dihydroartemisinin-piperaquine tablets for the treatment of uncomplicated Plasmodium falciparum malaria and Chloroquine for the treatment of Plasmodium vivax malaria in Bu Dang of Binh Phuoc, Tuy Duc of Dak Nong, Huong Hoa of Quang Tri and Gia Lai provinces, Viet Nam in 2010
Scientific title
Efficacy and safety of artesunate and dihydroartemisinin-piperaquine tablets for the treatment of uncomplicated Plasmodium falciparum malaria and Chloroquine for the treatment of Plasmodium vivax malaria in Bu Dang of Binh Phuoc, Tuy Duc of Dak Nong, Huong Hoa of Quang Tri and Gia Lai provinces, Viet Nam in 2010
Secondary ID [1] 253416 0
Nil
Universal Trial Number (UTN)
U1111-1118-8979
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 260898 0
Condition category
Condition code
Infection 259038 259038 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The efficacy and safety of 3 drugs used by the control program as anti-malarial standard treatment, artesunate, DHA-PIP and CQ, will be assessed separately in 4 different groups of patients in 3 different study sites. Pf malaria patients in Binh Phuoc and Dak Nong sites will receive Artesunate for 7 days; Pf patienst in Quang Tri and Gia Lai will recieve co-formulated DHA-PIP for 3 days; and vivax patienst in Quang Tri will receive CQ.
- Oral artesunate (50 mg/tab) will be administered at a total dose of 16 mg/kgbw over 7 days (1st day: 4 mg/kgbw, 2nd to 7th days: 2 mg/kgbw/day).
- Oral dihydroartemisinin-piperaquine(DHA-PIP) will be administered at a dose of 2mg/kg/day DHA and 16mg/kg/day PIP for 3 days.
- Oral chloroquine will be administered at a total dose of 25mg/kgbw (10 mg/kgbw on day0, 10mg/kgbw on day1 and 5 mg/kgbw on day2).
The WHO 28 day in vivo protocol, used in this study, consists of parasite count and temperature measurements at baseline (day0 before dosing) and on days 1, 2, 3, 7, 14, 21 and 28.
Intervention code [1] 257803 0
Treatment: Drugs
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259888 0
Primary Outcome 1: 28/42 -day cure rate or ACPR (adequate clinical and parasitological response)
(absence of parasitaemia on day 28/42, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure)
Timepoint [1] 259888 0
after start of the study : Day 1, Day 2, Day 3, Day 7, Day 14, Day 21, Day 28, Day 35 and Day 42
Secondary outcome [1] 268775 0
PCR-corrected ACPR (PCR: polymerase chain reaction, a molecular tool/test to differentiate if the failure is a true resistance or reinfection)
Timepoint [1] 268775 0
after start of study (Day 7, Day 14, Day 21, Day 28 with artesunate, chloroquine, Day 35 and Day 42 with Dihydroartemisinin - Piperaquine)

Eligibility
Key inclusion criteria
- age between 02 to 60 years old;
- mono-infection with P. falciparum or P. vivax detected by microscopy;
- Pf= parasitaemia of 500 – 100,000 asexual forms/ micro ml of blood;
- Pv = parasitemia 250-50,000 asexual forms/ micro ml of blood;
- presence of axillary temperature greater than or equal
37.5 degrees Centigrade 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
2 Years
Maximum age
60 Years
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 diarrhoea 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
- Single female with ages 12 – 18 years old.
- a positive pregnancy test or breastfeeding.
- unable to or unwilling to take contraceptives (for 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
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] 3123 0
Viet Nam
State/province [1] 3123 0
Binh Phuoc
Country [2] 3124 0
Viet Nam
State/province [2] 3124 0
Dak Nong
Country [3] 3125 0
Viet Nam
State/province [3] 3125 0
Quang Tri
Country [4] 3126 0
Viet Nam
State/province [4] 3126 0
Gia Lai

Funding & Sponsors
Funding source category [1] 258277 0
Other Collaborative groups
Name [1] 258277 0
World Health Organization
Address [1] 258277 0
World Health Organization Western Pacific Regional Office, United Nations Avenue, Manila 1000
Country [1] 258277 0
Philippines
Funding source category [2] 258278 0
Other
Name [2] 258278 0
Global Funds
Address [2] 258278 0
Ministry of Health
138A Giang Vo street, Ba Dinh, Ha Noi 10.000
Country [2] 258278 0
Viet Nam
Primary sponsor type
Government body
Name
Ministry of Health
Address
138A Giang Vo street, Ba Dinh, Ha Noi, 10.000
Country
Viet Nam
Secondary sponsor category [1] 257441 0
Government body
Name [1] 257441 0
IMPE Ho Chi Minh
Address [1] 257441 0
699 Tran Hung Dao street, ward 5, Ho Chi Minh City, 70.000
Country [1] 257441 0
Viet Nam
Secondary sponsor category [2] 257442 0
Government body
Name [2] 257442 0
IMPE Qui Nhon
Address [2] 257442 0
611B, Nguyen Thai Hoc street, Qui Nhon city, Binh Dinh province, 53.000
Country [2] 257442 0
Viet Nam
Other collaborator category [1] 251757 0
Other Collaborative groups
Name [1] 251757 0
Binh Phuoc malaria control center
Address [1] 251757 0
14 road, Tien Thanh Commune, Dong Xoai Town, Binh Phuoc Province, 77.000
Country [1] 251757 0
Viet Nam
Other collaborator category [2] 251758 0
Other Collaborative groups
Name [2] 251758 0
Dak Nong Provincial Malaria Center
Address [2] 251758 0
Nghia Tan Commune, Gia Nghia town, Dak Nong Province
Country [2] 251758 0
Viet Nam

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260257 0
Ethics committee of National Institute of malariology, Parasitology and Entomology
Ethics committee address [1] 260257 0
245 Luong The Vinh Street, Trung Van, Tu Liem, Hanoi
10.200
Ethics committee country [1] 260257 0
Viet Nam
Date submitted for ethics approval [1] 260257 0
29/03/2010
Approval date [1] 260257 0
10/04/2010
Ethics approval number [1] 260257 0
Ethics committee name [2] 260259 0
WHO WPRO Ethics Review Committee (ERC)
Ethics committee address [2] 260259 0
WHO Western Pacific Regional Office, United NAtionas Avenue, Manila 1000
Ethics committee country [2] 260259 0
Philippines
Date submitted for ethics approval [2] 260259 0
30/04/2010
Approval date [2] 260259 0
19/07/2010
Ethics approval number [2] 260259 0

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 dihydroartemisinin-piperaquine (DHA-PIP) and artesunate (AS7) monotherapy for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine (CQ) for the treatment of Plasmodium vivax malaria in 4 sites in Vietnam. The drugs and study sites are: AS7 in Bu Dang of Binh Phuoc and Tuy Duc of Dak Nong, DHA-PIP in Gia Lai, and DHA-PIP and CQ in Huong Hoa of Quang Tri, Viet Nam. The WHO 28-day in vivo protocol will be used. People with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with the ACT DHA-PIP or 7-day artesunate or chloroquine.
Trial website
WWW.nimpe.com.vn
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32059 0
Address 32059 0
Country 32059 0
Phone 32059 0
Fax 32059 0
Email 32059 0
Contact person for public queries
Name 15306 0
Tran Cong Dai
Address 15306 0
WHO Vietnam
63 Tran Hung Dao Street, Ha Noi, 10.000
Country 15306 0
Viet Nam
Phone 15306 0
+84 9132011706
Fax 15306 0
Email 15306 0
TranCongD@wpro.who.int
Contact person for scientific queries
Name 6234 0
Ta Thi Tinh
Address 6234 0
Head of Malaria Research & Treatment Department.
Natinal Institute of Malariology, Parasitology and Entomology
245 Luong The Vinh street, Trung van, Tu Liem, Ha Noi
10.200
Country 6234 0
Viet Nam
Phone 6234 0
+84912684889
Fax 6234 0
+84 438543015
Email 6234 0
tinhnimpe@yahoo.com

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