Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
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
Query!
Scientific title
Efficacy and safety of artesunate and dihydroartemisinin-piparaquine (DHA-PIP) for the treatment of uncomplicated Plasmodium falciparum malaria in Yunnan, China
Query!
Secondary ID [1]
253105
0
none
Query!
Universal Trial Number (UTN)
U1111-1117-7777
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
malaria
258665
0
Query!
Condition category
Condition code
Infection
258811
258811
0
0
Query!
Other infectious diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
257626
0
Treatment: Drugs
Query!
Comparator / control treatment
None
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
259672
0
28-day cure rate or ACPR (adequate clinical and parasitological response)
Query!
Assessment method [1]
259672
0
Query!
Timepoint [1]
259672
0
after start of the study
Query!
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)
Query!
Assessment method [2]
259673
0
Query!
Timepoint [2]
259673
0
at the end of the study
Query!
Secondary outcome [1]
266368
0
Safety. This will be assessed using the individual patient case report form or questionnaire during the study duration.
Query!
Assessment method [1]
266368
0
Query!
Timepoint [1]
266368
0
after start of study
Query!
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.
Query!
Minimum age
6
Months
Query!
Query!
Maximum age
60
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Date of first participant enrolment
Anticipated
1/09/2010
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
120
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
3048
0
China
Query!
State/province [1]
3048
0
Yunnan
Query!
Funding & Sponsors
Funding source category [1]
258081
0
Other
Query!
Name [1]
258081
0
World Health Organization
Query!
Address [1]
258081
0
World Health Organization Western Pacific Regional Office, United Nations Avenue, Manila 1000
Query!
Country [1]
258081
0
Philippines
Query!
Primary sponsor type
Government body
Query!
Name
National Institute of Parasitic Diseases, China Center for Disease Control and Prevention
Query!
Address
207 Ruijin No.2 Rd, Shanghai, 200025
Query!
Country
China
Query!
Secondary sponsor category [1]
257265
0
Government body
Query!
Name [1]
257265
0
Yunnan Institute of Parasitic Diseases
Query!
Address [1]
257265
0
6 Xiyuan Road, Puer, Yunnan province, 66500
Query!
Country [1]
257265
0
China
Query!
Other collaborator category [1]
251655
0
Hospital
Query!
Name [1]
251655
0
Labang Town Hospital
Query!
Address [1]
251655
0
Labang Town, Yingjiang County, Yunnan province, 679300
Query!
Country [1]
251655
0
China
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
260068
0
China Center for Disease Control and Prevention Ethical committee
Query!
Ethics committee address [1]
260068
0
155 Changli Rd, Beijing,102206
Query!
Ethics committee country [1]
260068
0
China
Query!
Date submitted for ethics approval [1]
260068
0
Query!
Approval date [1]
260068
0
07/06/2010
Query!
Ethics approval number [1]
260068
0
201007
Query!
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.
Query!
Trial website
None
Query!
Trial related presentations / publications
None
Query!
Public notes
Query!
Contacts
Principal investigator
Name
31922
0
Query!
Address
31922
0
Query!
Country
31922
0
Query!
Phone
31922
0
Query!
Fax
31922
0
Query!
Email
31922
0
Query!
Contact person for public queries
Name
15169
0
Tang Linhua
Query!
Address
15169
0
National Institute of Parasistic Diseases, China Center for Disease Control and Prevention
207 Ruijin No.2 Rd, Shanghai, 200025
Query!
Country
15169
0
China
Query!
Phone
15169
0
+86 21 6437 3359
Query!
Fax
15169
0
+86 21 6433 2670
Query!
Email
15169
0
[email protected]
Query!
Contact person for scientific queries
Name
6097
0
Tang Linhua
Query!
Address
6097
0
National Institute of Parasistic Diseases, China Center for Disease Control and Prevention
207 Ruijin No.2 Rd, Shanghai, 200025
Query!
Country
6097
0
China
Query!
Phone
6097
0
+86 21 6437 3359
Query!
Fax
6097
0
+86 21 6433 2670
Query!
Email
6097
0
[email protected]
Query!
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
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
A Single Mutation in K13 Predominates in Southern China and Is Associated With Delayed Clearance of Plasmodium falciparum Following Artemisinin Treatment
2015
https://doi.org/10.1093/infdis/jiv249
Dimensions AI
No evidence of amplified Plasmodium falciparum plasmepsin II gene copy number in an area with artemisinin-resistant malaria along the China–Myanmar border
2020
https://doi.org/10.1186/s12936-020-03410-6
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF