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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12614000344695
Date of registration: 31/03/2014
Prospective Registration: No
Primary sponsor: Ministry of Health of Cambodia
Public title: Routine Monitoring and Evaluation of efficacy and safety of Dihydroartemisinin-Piperaquine in Trapaeng Raeng Centre (Kampot), in Phnom Dek Centre ( Preah Vihear), in Snuol Centre (Kratie), and in Veunsai centre (Ratanakiri) for the treatment of uncompleted Plasmodium falciparum malaria and Plasmodium vivax malaria (Only in Kampot and Ratanakiri) in Cambodia
Scientific title: Routine Monitoring and Evaluation of efficacy and safety of Dihydroartemisinin-Piperaquine in Trapaeng Raeng Centre (Kampot), in Phnom Dek Centre ( Preah Vihear), in Snuol Centre (Kratie), and in Veunsai centre (Ratanakiri) for the treatment of uncompleted Plasmodium falciparum malaria and Plasmodium vivax malaria (Only in Kampot and Ratanakiri) in Cambodia
Date of first enrolment: 09/11/2013
Target sample size: 240
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12614000344695.aspx
Study type:  Interventional
Study design:  Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;  
Phase:  Not Applicable
Countries of recruitment
Cambodia
Contacts
Name: Dr Didier Menard   
Address:  Institute Pasteur of Cambodia 5 Blvd Monivong, BP 983 Phnom Penh, Cambodia Cambodia
Telephone: 855 12 715 666
Email: dmenard@pasteur-kh.org
Affiliation: 
Name: Dr Mey Bouth Denis   
Address:  National Centre for Parasitology, Entomology and Malaria Control # 372 Monivong Blvd (322 Corner St.), Phnom Penh Cambodia
Telephone: 855 12 858 320
Email: meybouthd@gmail.com
Affiliation: 
Key inclusion & exclusion criteria
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 or P. vivax detected by microscopy; P. falciparum or P. vivax parasitaemia of 500-100,000/microliter asexual forms;
- 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

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


Age minimum: 2 Years
Age maximum: 60 Years
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Patient with Plasmodium falciparum infection;Patient with Plasmodium vivax infection;
Patient with Plasmodium falciparum infection
Patient with Plasmodium vivax infection
Infection - Other infectious diseases
Intervention(s)
-Patients with P. falciparum or P. vivax infection are orally treated with Dihydroartemisinin-Piperaquine with the adult dose of 2-4 mg/kg for Dihydroartemisinin and 20mg/kg for Piperaquine over 3 consecutive days.
- Patients have to take each dose of drug in front of the medical staff at the study site and closely observed for the first 30 minutes following each dose.
- Patients who vomit in less than 30 minutes or vomit after one hour after administration of the treatment will be re-administered the full dose of the treatment".
Primary Outcome(s)
- Proportion of adequate clinical and parasitological response of the patients with P.falciparum and P. vivax to the treatment of DHA-PIP.
- Polymerase chain reaction is used to differentiate between reinfection and recrudescence for the recurrent infection at day 28 and day 42.[the treatment outcome will be evaluated at day 28 and day 42 after the completion of a complete 3-day treatment course at day0, day 1 and day2. ]
Secondary Outcome(s)
Proportion of treatment failure of the patients with P. falciparum and P. vivax to Dihydroartemisinin-Piperaquine by applying the method of polymerase chain reaction (PCR) which is to differentiate between the reinfection and recrudescence at day 28 and day 42. [the treatment outcome will be evaluated at day 28 and day 42 after the completion of a complete 3-day treatment course at day0, day 1 and day2. ]
Secondary ID(s)
Nil known
Source(s) of Monetary Support
World Health Organization
Secondary Sponsor(s)
National Center for Parasitology, Entomology and Malaria Control
Ethics review
Status: Approved
Approval date:
Contact:
National Ethics Committee for Health Research
Results
Results available:
Date Posted:
Date Completed:
URL:
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