Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000696594
Ethics application status
Approved
Date submitted
12/06/2015
Date registered
3/07/2015
Date last updated
3/07/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Routine Monitoring and Evaluation of efficacy and safety of Dihydroartemisinin-Piperaquine in Kvav Health Centre (Siemreap), in Kbal Romeas ( Stung Treng), in Veurn Sai (Rattanakiri) and in Koh Ngek Health Centre (Mondulkiri) for the treatment of uncomplicated Plasmodium falciparum malaria in Cambodia 2014.
Scientific title
Routine Monitoring and Evaluation of efficacy and safety of Dihydroartemisinin-Piperaquine in Kvav Health Centre (Siemreap), in Kbal Romeas ( Stung Treng), in Veurn Sai (Rattanakiri) and in Koh Ngek Health Centre (Mondulkiri) for the treatment of uncomplicated Plasmodium falciparum malaria in Cambodia 2014.
Secondary ID [1] 286901 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uncomplicated Plasmodium falciparum Malaria 295315 0
Condition category
Condition code
Infection 295583 295583 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
DHA-PIP (DHA-PIP Trademark, Holley Kin Pharmaceutical Co. Ltd, Guangzhou, China): one tablet of DHA-PIP contains 40mg of dihydroartemisinin (DHA) and 320 mg piperaquine (PIP). It is an oral [by mouth] administration, one dose a day for 3 consecutive days. An adult dose (from 40 kg to 60kg body weight or more than 15 years old) consisted of three doses of 3 tablets over consecutive days (Total dose 9 tablets). The approximate total adult dose was 2-4 mg/kg for DHA and 20mg/kg for PIP.

All doses of medicine will be administered under the supervision of a qualified member of the staff designated by the principal investigator. The study patients will be observed for 30 min after medicine administration for adverse reactions or vomiting. Any patient who vomits during this observation period will be re-treated with the same dose of medicine and observed for an additional 30 min. If the patient vomits again, he or she will be withdrawn and offered rescue therapy. The patients are recommended to stay at the health facilities until they complete the treatment course for malaria infection.
Intervention code [1] 292086 0
Treatment: Drugs
Comparator / control treatment
No control. Open label study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295289 0
The proportion of patients with treatment failures. Patients will be classified as early late clinical failure, late parasitological failure or an adequate clinical and parasitological response. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis.
Timepoint [1] 295289 0
days 1, 2, 3, 7, 14, 21, 28, 35 and 42.
Secondary outcome [1] 315272 0
The frequency and nature of adverse events. Clinical examination to detect blistering, peeling, loosening of skin, chills, convulsions, difficulty swallowing, fast heartbeat, joint or muscle pain etc...
Timepoint [1] 315272 0
days 1, 2, 3, 7, 14, 21, 28, 35 and 42.

Eligibility
Key inclusion criteria
*age between 2 and 60 years except unmarried females between 12 and 18 years old (potential unpredicted pregnancy);
mono-infection with P. falciparum by microscopy; P. falciparum parasitaemia of 500-100,000/microliter asexual forms;
*presence of axillary above to 37.5 °C or history of fever during the past 24 h;
*ability to swallow oral [by mouth] 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 aged less than 12 years;
*informed assent from any minor participant aged more than 12 years and less than 60 years; and
*consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under 18 years.
Minimum age
2 Years
Maximum age
No limit
Sex
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;
*weight under 5 kg;
*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 diarrhea 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);
*unmarried women 12-18 years old;
*a positive pregnancy test or breastfeeding;
*unable to or unwilling to take a pregnancy test or unwilling to take pregnancy test or contraceptives (for women of child-bearing age).

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2014
Actual
15/05/2014
Date of last participant enrolment
Anticipated
28/02/2015
Actual
18/02/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 6971 0
Cambodia
State/province [1] 6971 0
Siemreap
Country [2] 7001 0
Cambodia
State/province [2] 7001 0
Stung Treng
Country [3] 7002 0
Cambodia
State/province [3] 7002 0
Mondulkiri
Country [4] 7003 0
Cambodia
State/province [4] 7003 0
Rattanakiri

Funding & Sponsors
Funding source category [1] 291455 0
Government body
Name [1] 291455 0
Ministry of Health, Cambodia
Country [1] 291455 0
Cambodia
Primary sponsor type
Government body
Name
Ministry of Health, Cambodia
Address
Nº 27 B2 , St 656, Khan Toul Kork,
Phnom Penh, Cambodia
Office: #372, Monivong Blvd.
Phnom Penh, Cambodia
P.O. box 1062
Country
Cambodia
Secondary sponsor category [1] 290135 0
Government body
Name [1] 290135 0
National Centre for Parasitology, Entomology and Malaria Control Program, Cambodia
Address [1] 290135 0
#372, Monivong Blvd, Corner St. 322
Phnom Penh, Cambodia
Country [1] 290135 0
Cambodia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The general objective of this study is to assess the efficacy and safety of Dihydroartemisinin-Piperaquine in Kvav Health Centre (Siemreap), in Kbal Romeas ( Stung Treng) and in Koh Ngek Health Centre (Mondulkiri) for the treatment of uncomplicated Plasmodium falciparum malaria in Cambodia.
The primary objectives are:
*to measure the clinical and parasitological efficacy of Dihydroartemisinin-Piperaquine for the treatment of uncomplicated P. falciparum in patients aged between 2 and 60 years old, except unmarried 12-18 females, suffering from P. falciparum by determining the proportion with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy;
*to differentiate recrudescence from new infection by polymerase chain reaction (PCR) analysis for P. falciparum malaria;
The secondary objectives are:
*to evaluate the incidence of adverse events; and
*to formulate recommendations and to enable the Ministry of Health to make informed decisions about whether the current national antimalarial treatment guidelines should be updated.
The exploratory objectives are:
*to assess the in vitro susceptibility of P. falciparum solates to dihydroarteminisinin, piperaquine at D0 and Day of recrudescence;
*to determine the polymorphism of molecular markers of Plasmodium falciparum and Kelch gene

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58050 0
Dr Rithea Leang
Address 58050 0
National Centre for Parasitology, Entomology and Malaria Control
Cambodia
#372, Monivong Blvd, Corner St. 322
Phnom Penh, Cambodia
Country 58050 0
Cambodia
Phone 58050 0
855 12 715 666
Fax 58050 0
Email 58050 0
[email protected]
Contact person for public queries
Name 58051 0
Dr Rithea Leang
Address 58051 0
National Centre for Parasitology, Entomology and Malaria Control
Cambodia
#372, Monivong Blvd, Corner St. 322
Phnom Penh, Cambodia
Country 58051 0
Cambodia
Phone 58051 0
855 12 715 666
Fax 58051 0
Email 58051 0
[email protected]
Contact person for scientific queries
Name 58052 0
Dr Rithea Leang
Address 58052 0
National Centre for Parasitology, Entomology and Malaria Control
Cambodia
#372, Monivong Blvd, Corner St. 322
Phnom Penh, Cambodia
Country 58052 0
Cambodia
Phone 58052 0
855 12 715 666
Fax 58052 0
Email 58052 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
SourceTitleYear of PublicationDOI
Dimensions AIPlasmodium falciparum dihydroartemisinin-piperaquine failures in Cambodia are associated with mutant K13 parasites presenting high survival rates in novel piperaquine in vitro assays: retrospective and prospective investigations2015https://doi.org/10.1186/s12916-015-0539-5
N.B. These documents automatically identified may not have been verified by the study sponsor.