Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000214639
Ethics application status
Approved
Date submitted
27/12/2013
Date registered
28/02/2014
Date last updated
28/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of Dihydroartemisinine-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria, and chloroquine for Plasmodium vivax in Homalin (Sagaing Division), Lashio (Shan State) and Bokepyin (Tanintharyi Division).
Scientific title
A study evaluating the efficacy and safety of Dihydroartemisinine-piperaquine for the treatment of uncomplicated plasmodium falciparum malaria, and chloroquine for plasmodium vivax in Homalin (Sagaing Division), Lashio (Shan State) and Bokepyin (Tanintharyi Division)
Secondary ID [1] 283821 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 290796 0
Condition category
Condition code
Infection 291164 291164 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients are over 13 years of age. For patients with plasmodium falciparum malaria dihydroartemisinin-piperaquine will be administered 2-2.4/16-19.2 mg/kg (Body weight will be recorded on day 0 to the nearest kilogram on a Salter scale. Patients should not wear excessive clothing while being weighed as this can overestimate their true weight. The screening weight will be used to satisfy the inclusion or exclusion for nutrition status as well as to calculate the dose (number of tablets) to be administered) once a day orally for 3 days. Less than 18 kgs will be given one tablet per day. Less than 29 kgs will be given 1 and a half tablets per day, less than 39 kgs will be given 2 tablets per day and over 40 Kgs will be given three tablets per day. Each tablet contains 40mg dihydroartemisinin and 320mg piperaquine phosphate.

For patients with P. vivax malaria will be administered with chloroquine 10 mg, 10 mg and 5 mg per kg orally on day 0, 1 and 2 respectively.
Enrolled patients will be observed for at least 30 min after treatment to ensure that they do not vomit the medicine. If vomiting occurs within 30 min of treatment, the full treatment dose will be repeated.
Thereafter, patients are required to undergo regular clinical reassessment. Blood films for parasite counts will be made on days 2, 3 and 7 and then weekly for the remainder of the follow-up period, i.e. on days 14, 21, 28.
Intervention code [1] 288508 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291153 0
The patient will be monitored for 42 days when treated with Dihydroartemisinine-piperaquine and for 28 days when treated with chloroquine. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. P. falciparum patients will be hospitalized for 7 days or until parasite clearance. On the basis of the results of the assessments, patients will be classified as having early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response.The proportion of patients experiencing therapeutic failure during the follow-up period will be used to estimate the efficacy of the study drug(s). PCR analysis will be used to distinguish between a true recrudescence due to treatment failure and episodes of reinfection for falciparum malaria.
Timepoint [1] 291153 0
28 days after chloroquine and 42 days for dihydroartemisinine-piperaquine
Secondary outcome [1] 306149 0
nil
Timepoint [1] 306149 0
nil

Eligibility
Key inclusion criteria
- age above 13 years inclusive and above except females aged 13-17 year old inclusive;
- mono-infection with P. falciparum detected by microscopy (parasitaemia of 500-100,000/micro litre asexual forms) or P. vivax detected by microscopy (parasitaemia greater than 250/micro litre asexual forms);
- presence of axillary equal to 37.5 degrees celsius 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
13 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- presence signs of severe falciparum malaria according to the definitions of WHO;
- mixed or mono-infection with another Plasmodium species detected by microscopy;
- 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
- a positive pregnancy test or breastfeeding;
- unable to or unwilling to take a pregnancy test or contraceptives.

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)
Patients on site having symptoms of malaria
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
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/01/2014
Actual
1/01/2014
Date of last participant enrolment
Anticipated
1/01/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 5701 0
Myanmar
State/province [1] 5701 0
Lashio (Shan State)
Country [2] 5702 0
Myanmar
State/province [2] 5702 0
Bokepyin (Tanintharyi Division)
Country [3] 5703 0
Myanmar
State/province [3] 5703 0
Homalin (Sagaing Division)

Funding & Sponsors
Funding source category [1] 288480 0
Charities/Societies/Foundations
Name [1] 288480 0
World Health Organization
Country [1] 288480 0
Switzerland
Primary sponsor type
Hospital
Name
Clinical Research Unit (malaria), Defense Services General Hospital
Address
Ministry of Defence, Mingalardon
Yangon
Country
Myanmar
Secondary sponsor category [1] 287179 0
None
Name [1] 287179 0
Nil
Address [1] 287179 0
Country [1] 287179 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290342 0
Medical Ethics Committee
Ethics committee address [1] 290342 0
The Republic of the Union of Myanmar Office of the Commander in Chief (Army) Directorate of Medical Services
Yangon
Ethics committee country [1] 290342 0
Myanmar
Date submitted for ethics approval [1] 290342 0
14/08/2013
Approval date [1] 290342 0
26/08/2013
Ethics approval number [1] 290342 0
Ethics committee name [2] 290343 0
World Health Organization Research Ethics Review Committee
Ethics committee address [2] 290343 0
20 avenue Appia
CH 1211 Geneve 20
Ethics committee country [2] 290343 0
Switzerland
Date submitted for ethics approval [2] 290343 0
24/07/2013
Approval date [2] 290343 0
22/11/2013
Ethics approval number [2] 290343 0
RPC598

Summary
Brief summary
To study the efficacy of antimalarial drugs in Myanmar.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45198 0
Dr Khin Phyu Pyar
Address 45198 0
Consultant Physician
Head of Clinical Research Unit (Malaria)
No (1) Defense Services General Hospital (1000 beds), Mingaladon
Country 45198 0
Myanmar
Phone 45198 0
+9513135195
Fax 45198 0
Email 45198 0
[email protected]
Contact person for public queries
Name 45199 0
Dr Sai Aik Hla
Address 45199 0
Physician/Member of Clinical Research Unit (Malaria)
No (1) Defense Services General Hospital (1000 beds), Mingaladon
Country 45199 0
Myanmar
Phone 45199 0
+9513135195
Fax 45199 0
Email 45199 0
[email protected]
Contact person for scientific queries
Name 45200 0
Dr Khin Phyu Pyar
Address 45200 0
Consultant Physician
Head of Clinical Research Unit (Malaria)
No (1) Defense Services General Hospital (1000 beds), Mingaladon
Country 45200 0
Myanmar
Phone 45200 0
+9513135195
Fax 45200 0
Email 45200 0
[email protected]

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
No additional documents have been identified.