Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000181909
Ethics application status
Approved
Date submitted
15/02/2011
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 tablet and drug combination (dihydroartemisinin – piperaquine) for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for vivax malaria in 5 sentinel sites (Binh Phuoc, Dak Nong, Gia Lai, Ninh Thuan and Quang Tri provinces), Viet Nam in 2008 and 2009
Scientific title
Efficacy and safety of artesunate tablet and drug combination (dihydroartemisinin – piperaquine) for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for vivax malaria in 5 sentinel sites (Binh Phuoc, Dak Nong, Gia Lai, Ninh Thuan and Quang Tri provinces), Viet Nam in 2008 and 2009
Secondary ID [1] 253365 0
Nil
Universal Trial Number (UTN)
U1111-1118-9072
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 260899 0
Condition category
Condition code
Infection 259039 259039 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 9 different groups of patients in 5 different study sites. Pf malaria patients in Binh Phuoc and Ninh Thuan sites will receive Artesunate for 7 days in 2008 and in Quang Tri site in 2009. Pf malaria patients in Quang Tri, Gia Lai sites will receive DHA-PIP for 3 days in 2008 and in Binh Phuoc, Dak Nong sites in 2009. Pv malaria patients in Ninh Thuan and Binh phuoc will receive CQ for 3 days in 2009.
- 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] 257804 0
Treatment: Drugs
Comparator / control treatment
single group trials
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259889 0
28-day cure rate or ACPR (adequate clinical and parasitological response) (absence of Parasitemia on day 28, irrespective of axillary temparature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure of late parasitological failure).
Timepoint [1] 259889 0
after start of the study: Day 1, Day 2, Day 3, Day 7, Day 14, Day 21 and D28.
Secondary outcome [1] 268776 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] 268776 0
after start of the study (Day 7, Day 14, Day 21 and Day 28)

Eligibility
Key inclusion criteria
- Adults and children over 6 months old;
- single Infection with P. falciparum;
- Parasitaemia: 1 000–200 000 asexual forms per micro ml of blood;
- Presence of axillary temperature greater than or eqqual 37.5 degrees Centigrade or history of fever within the previous 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 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 among children <5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions.
- Mixed or mono-infection with another Plasmodium species;
- Presence of severe malnutrition
- Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhoea with dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases, HIV/AIDS);
- History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment;
- Positive pregnancy test or lactating

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
1/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 3127 0
Viet Nam
State/province [1] 3127 0
Gia Lai
Country [2] 3128 0
Viet Nam
State/province [2] 3128 0
Quang Tri
Country [3] 3129 0
Viet Nam
State/province [3] 3129 0
Ninh Thuan
Country [4] 3130 0
Viet Nam
State/province [4] 3130 0
Binh phuoc

Funding & Sponsors
Funding source category [1] 258280 0
Other
Name [1] 258280 0
WHO
Country [1] 258280 0
Philippines
Funding source category [2] 258281 0
Other
Name [2] 258281 0
Global funds
Country [2] 258281 0
Viet Nam
Primary sponsor type
Other
Name
Ministry of Health
Address
138A Giang vo street, Ba Dinh, Ha Noi, 10.000
Country
Viet Nam
Secondary sponsor category [1] 257443 0
Other
Name [1] 257443 0
IMPE Ho Chi Minh
Address [1] 257443 0
699 Tran Hung Dao, Ward 5, Ho Chi Minh city, 70.000
Country [1] 257443 0
Viet Nam
Secondary sponsor category [2] 257444 0
Other
Name [2] 257444 0
IMPE Qui Nhon
Address [2] 257444 0
611B, Nguyen Thai Hoc Street, Quinhon city, Binh Dinh Province, 53.000
Country [2] 257444 0
Viet Nam
Other collaborator category [1] 251759 0
Other Collaborative groups
Name [1] 251759 0
Binh Phuoc Malaria center
Address [1] 251759 0
14 road, Tien Thanh commune, Dong Xoai town, Binh Phuoc province, 77.000
Country [1] 251759 0
Viet Nam
Other collaborator category [2] 251760 0
Other Collaborative groups
Name [2] 251760 0
Ninh Thuan Malaria center
Address [2] 251760 0
156 Ngo Gia Tu street, Phan Rang - Thap Cham city, Ninh Thuan Province, 63.000
Country [2] 251760 0
Viet Nam
Other collaborator category [3] 251761 0
Other Collaborative groups
Name [3] 251761 0
Dak Nong malaria center
Address [3] 251761 0
Nghia Tan commnue, Gia Nghia town, Dak Nong Province, 64.000
Country [3] 251761 0
Viet Nam
Other collaborator category [4] 251762 0
Other Collaborative groups
Name [4] 251762 0
Gia Lai Malaria center
Address [4] 251762 0
63 Phan Dinh Phung street, Pleiku city, Gia lai province, 54.000
Country [4] 251762 0
Viet Nam
Other collaborator category [5] 251763 0
Other Collaborative groups
Name [5] 251763 0
Quang Tri Malaria center
Address [5] 251763 0
Hoang Dieu street, Dong Ha city, Quang tri Province, , 46.000
Country [5] 251763 0
Viet Nam

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260260 0
Ethics Committee of National Institute of Malarialogy, Parasitology and Entomology
Ethics committee address [1] 260260 0
245 Luong The Vinh street, Trung Van, Tu Liem, Hanoi, 10.200
Ethics committee country [1] 260260 0
Viet Nam
Date submitted for ethics approval [1] 260260 0
30/07/2008
Approval date [1] 260260 0
10/08/2008
Ethics approval number [1] 260260 0
Ethics committee name [2] 260261 0
WHO WPRO Ethics Review Committee (ERC)
Ethics committee address [2] 260261 0
WHO Western Pacific Regional Office, United NAtionas Avenue, Manila 1000.
Ethics committee country [2] 260261 0
Philippines
Date submitted for ethics approval [2] 260261 0
06/09/2008
Approval date [2] 260261 0
02/10/2008
Ethics approval number [2] 260261 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 5 sites in Vietnam. The drugs and study sites are: AS7 in Bu Dang of Binh Phuoc, Huong Hoa of Quang Tri and Bac Ai of Ninh Thuan, DHA-PIP in Gia Lai, Quang Tri, Binh phuoc, and Dak Nong, CQ in Ninh Son of Ninh Thuan and Bu Dang of Binh Phuoc, 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 monotherapy for Pf cases and CQ for Pv cases, 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 Viet Nam in assessing the current national treatment guidelines for uncomplicated P. falciparum and P. vivax malaria.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32061 0
Address 32061 0
Country 32061 0
Phone 32061 0
Fax 32061 0
Email 32061 0
Contact person for public queries
Name 15308 0
Tran Cong Dai
Address 15308 0
WHO - Vietnam
63 Tran Hung Dao, Hanoi, 10.000
Country 15308 0
Viet Nam
Phone 15308 0
+84 913201706
Fax 15308 0
Email 15308 0
TranCongD@wpro.who.int
Contact person for scientific queries
Name 6236 0
Ta Thi Tinh
Address 6236 0
Head of malaria Research and Treatment
245 Luong The Vinh street, Trung Van, Tuliem, Hanoi
10.200
Country 6236 0
Viet Nam
Phone 6236 0
+84 912 684 889
Fax 6236 0
+ 84 38543015
Email 6236 0
tinhnimpe@yahoo.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

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