Please be advised that due to the high volume of submissions, the ANZCTR is currently experiencing delays in processing submissions from those outside of Australia and New Zealand. As the ANZCTR is funded by Australia and New Zealand, we must prioritise submissions from these countries first. International submissions should allow additional time for registration. Apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610001028099
Ethics application status
Approved
Date submitted
16/11/2010
Date registered
23/11/2010
Date last updated
23/11/2010
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 in Yunnan, China
Scientific title
Efficacy and safety of artesunate and dihydroartemisinin-piparaquine (DHA-PIP) for the treatment of uncomplicated Plasmodium falciparum malaria in Yunnan, China
Secondary ID [1] 253105 0
none
Universal Trial Number (UTN)
U1111-1117-7777
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
malaria 258665 0
Condition category
Condition code
Infection 258811 258811 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The efficacy and safety of 2 drugs used by the control program as anti-malarial standard treatment, artesunate and DHA-PIP, will be assessed separately in 2 different groups of patients in 2 different study sites. Malaria patients in Yingjiang, Dehong site will receive co-formulated DHA-PIP for 3 days. Patients in Menglian site will receive Artesunate for 7 days.
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).
Dydroartimisinin- piperquine(DHA-PIP) dose is a dose of 2mg/kg/day DHA and 16mg/kg/day PIP for 3 days.
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] 257626 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259672 0
28-day cure rate or ACPR (adequate clinical and parasitological response)
Timepoint [1] 259672 0
after start of the study
Primary outcome [2] 259673 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] 259673 0
at the end of the study
Secondary outcome [1] 266368 0
Safety. This will be assessed using the individual patient case report form or questionnaire during the study duration.
Timepoint [1] 266368 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
- 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 that 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
- 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.

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
Active, not 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] 3048 0
China
State/province [1] 3048 0
Yunnan

Funding & Sponsors
Funding source category [1] 258081 0
Other
Name [1] 258081 0
World Health Organization
Address [1] 258081 0
World Health Organization Western Pacific Regional Office, United Nations Avenue, Manila 1000
Country [1] 258081 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] 257265 0
Government body
Name [1] 257265 0
Yunnan Institute of Parasitic Diseases
Address [1] 257265 0
6 Xiyuan Road, Puer, Yunnan province, 66500
Country [1] 257265 0
China
Other collaborator category [1] 251655 0
Hospital
Name [1] 251655 0
Labang Town Hospital
Address [1] 251655 0
Labang Town, Yingjiang County, Yunnan province, 679300
Country [1] 251655 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260068 0
China Center for Disease Control and Prevention Ethical committee
Ethics committee address [1] 260068 0
155 Changli Rd, Beijing,102206
Ethics committee country [1] 260068 0
China
Date submitted for ethics approval [1] 260068 0
Approval date [1] 260068 0
07/06/2010
Ethics approval number [1] 260068 0
201007

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 in 2 sites Dehong and Menglian, Pu’er, Yunnan province in 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 ACT DHA-PIP or 7-day artesunate monotherapy 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 malaria.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 31922 0
Address 31922 0
Country 31922 0
Phone 31922 0
Fax 31922 0
Email 31922 0
Contact person for public queries
Name 15169 0
Tang Linhua
Address 15169 0
National Institute of Parasistic Diseases, China Center for Disease Control and Prevention
207 Ruijin No.2 Rd, Shanghai, 200025
Country 15169 0
China
Phone 15169 0
+86 21 6437 3359
Fax 15169 0
+86 21 6433 2670
Email 15169 0
ipdtlh@public3.sta.net.cn
Contact person for scientific queries
Name 6097 0
Tang Linhua
Address 6097 0
National Institute of Parasistic Diseases, China Center for Disease Control and Prevention
207 Ruijin No.2 Rd, Shanghai, 200025
Country 6097 0
China
Phone 6097 0
+86 21 6437 3359
Fax 6097 0
+86 21 6433 2670
Email 6097 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