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Trial registered on ANZCTR


Registration number
ACTRN12610001008011
Ethics application status
Approved
Date submitted
16/11/2010
Date registered
18/11/2010
Date last updated
18/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of artesunate and dihydroartemisinin-piparaquine (DHA-PIP) for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine in Plasmodium vivax malaria in Yunnan and Jiangsu province, China
Scientific title
Efficacy and safety of artesunate and dihydroartemisinin-piparaquine (DHA-PIP) for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine in Plasmodium vivax malaria in Yunnan and Jiangsu province, China
Secondary ID [1] 253106 0
None
Universal Trial Number (UTN)
U1111-1118-1628
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 258667 0
Condition category
Condition code
Infection 258812 258812 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
P. falciparum patients will receive either artesunate or DHA-PIP, and P. vivax patients will receive chloroquine. All drugs will be given by oral route.
Artesunate 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).
Dihydroartemisinin-Piperaquine (DHA-PIP) will be administered at a total dose of 2mg/kg/day DHA and 16mg/kg/day PIP for 3 days.
Chloroquine total dose is 25 mg/kgbw over 3 days. (1st day: 10mg/kgbw, 2nd day: 10mg/kgbw and 3rd day: 5 mg/kgbw).
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] 257627 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259674 0
Primary Outcome 1: 28-day cure rate or ACPR (adequate clinical and parasitological response)
Timepoint [1] 259674 0
after start of the study
Primary outcome [2] 259675 0
PCR-corrected ACPR (PCR: polymerase chain reaction, a molecular tool/test to differentiate if the failure is a true resistance or reinfection)
Timepoint [2] 259675 0
at the end of the study
Secondary outcome [1] 266369 0
Safety. This will be assessed using the individual patient case report form or questionnaire during the study duration.
Timepoint [1] 266369 0
after start of study

Eligibility
Key inclusion criteria
- age between 6 months to 60 years old;
- mono-infection with P. falciparum detected by microscopy with parasitaemia of 1000-100,000/ul asexual forms
- mono-infection with P. vivax detected by microscopy with parasitaemia of more than 250/ul asexual forms
- presence of axillary or tympanic temperature = 37.5 degrees centigrade, or oral or rectal temperature of = 38 degrees centigrade 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
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);
- a positive pregnancy test or breastfeeding;
- unable to or unwilling to take a pregnancy test or contraceptives (for women of child-bearing age);
unmarried women 12-18 years old;
- G6PD deficiency for P.vivax patients.

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
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 3049 0
China
State/province [1] 3049 0
Yunnan
Country [2] 3050 0
China
State/province [2] 3050 0
Jiangsu

Funding & Sponsors
Funding source category [1] 258082 0
Other
Name [1] 258082 0
World Health Organization
Address [1] 258082 0
World Health Organization Western Pacific Regional Office, United Nations Avenue, Manila 1000
Country [1] 258082 0
Philippines
Primary sponsor type
Government body
Name
National Institute of Parasitic Diseases, China Center for Disease Control and Prevention
Address
207 Ruijin No.2 Rd, Shanghai, 200025
Country
China
Secondary sponsor category [1] 257266 0
Government body
Name [1] 257266 0
Yunnan Institute of Parasitic Diseases
Address [1] 257266 0
6 Xiyuan Road, Puer city, Yunnan province, 66500
Country [1] 257266 0
China
Secondary sponsor category [2] 257267 0
Government body
Name [2] 257267 0
Jiangsu Institute of Parasitic Diseases
Address [2] 257267 0
Mei Yuan Road, Wuxi City, Jiangsu province, 214000
Country [2] 257267 0
China
Other collaborator category [1] 251656 0
Hospital
Name [1] 251656 0
Labang Town Hospital
Address [1] 251656 0
Labang Town, Yingjiang County, Yunnan province, 679300
Country [1] 251656 0
China
Other collaborator category [2] 251657 0
Hospital
Name [2] 251657 0
Liji Town Hospital
Address [2] 251657 0
Liji Town, Suining County, Jiangsu province, 221200
Country [2] 251657 0
China
Other collaborator category [3] 251658 0
Hospital
Name [3] 251658 0
Taoyuan Town Hospital
Address [3] 251658 0
Taoyuan Town, Suining County, Jiangsu province, 221200
Country [3] 251658 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260072 0
National Institute of Parasitic Diseases, China CDC Ethical committee
Ethics committee address [1] 260072 0
207 Ruijin No.2 Road, Shanghai, 200025
Ethics committee country [1] 260072 0
China
Date submitted for ethics approval [1] 260072 0
Approval date [1] 260072 0
28/04/2008
Ethics approval number [1] 260072 0
none

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 P. vivax malaria in 3 sites Dehong and Menglian, Pu’er, in Yunnan province and in Suining county in Jiangsu province, China. 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 appropriate drugs 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 China in assessing the current national treatment guidelines for uncomplicated P. falciparum and P. vivax malaria.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 31923 0
Address 31923 0
Country 31923 0
Phone 31923 0
Fax 31923 0
Email 31923 0
Contact person for public queries
Name 15170 0
Tang Linhua
Address 15170 0
National Institute of Parasistic Diseases, China Center for Disease Control and Prevention
207 Ruijin No.2 Rd, Shanghai, 200025
Country 15170 0
China
Phone 15170 0
+86 21 6437 3359
Fax 15170 0
+86 21 6433 2670
Email 15170 0
ipdtlh@public3.sta.net.cn
Contact person for scientific queries
Name 6098 0
Tang Linhua
Address 6098 0
National Institute of Parasistic Diseases, China Center for Disease Control and Prevention
207 Ruijin No.2 Rd, Shanghai, 200025
Country 6098 0
China
Phone 6098 0
+86 21 6437 3359
Fax 6098 0
+86 21 6433 2670
Email 6098 0
ipdtlh@public3.sta.net.cn

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