Efficacy and safety of dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in 6 sentinel sites in Indonesia

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000753651
• Date of registration: 16/07/2014
• Prospective Registration: Yes
• Primary sponsor: Ministry of Health
• Public title: Efficacy and safety of dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in 6 sentinel sites in Indonesia
• Scientific title: Efficacy and safety of dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in 6 sentinel sites in Indonesia
• Date of first enrolment: 15/08/2014
• Target sample size: 1200
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12614000753651.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: Phase 4

Countries of recruitment

Indonesia

Contacts

• Name: Dr Jeanne Rini Poespoprodjo

• Name: Dr Jeanne Rini Poespoprodjo

Key inclusion & exclusion criteria

Inclusion criteria: *age between one year (weight more than 5 kgs) to 65 years old;
*mono-infection with P. falciparum or P. vivax detected by microscopy;
*parasitaemia of more than 1000/µl asexual parasites
*presence of axillary temperature equal to or greater than 37.5 degrees Centigrade 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.

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 (Appendix 1); presence of danger signs as described in appendix 1 in patients with P. vivax infections
*Unmarried females over 12 years of age or who have had their menarche
*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 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 in eligible married women (include this criterion only if adults are included)


Age minimum: 3 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Malaria;
Malaria

Infection - Studies of infection and infectious agents

Intervention(s)

To assess the efficacy and safety of dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax in 6 sentinel sites in Indonesia.

Dose regimen:
Dihydroartemisinin-piperaquine (tablet containing 40 mg dihydroartemisinin and 320 mg piperaquine): 2.25/18 mg/kg once daily for three consecutive days according to the following weight bands:6-10 kg body weight: 1/2 tablet, 11-17 kg body weight (bw): 1 tablet; 18-30 kg body weight (bw): 1 1/2 tablets; 31-40 kg body weight (bw): 2 tablets; 41-60 kg body weight: 3 tablets. The treatment will be taken orally under supervision of the study team. Eligibile subjects will be treated for three days and followed up for 28 days.

Primary Outcome(s)

% of adverse events (abdominal discomfort, nausea, headache and dizziness and any other events) in the dihydroartemisinin-piperaquine treated patients. All patients will be asked routinely about previous symptoms and about symptoms that have emerged since the previous follow-up visit. All adverse events will be recorded on the adverse event form[At 42 day following treatment]

% of dihydroartemisinin-piperaquine treatment failures (early treatment failure+late clinical failure+late parasitological failure). Enrolled patients will be assessed for parasitological (using microscopy) and clinical responses during the 42 days follow-up and treatment outcomes will be classified according to the latest WHO protocol (http://www.who.int/malaria/publications/atoz/9789241597531/en/index.html).[At 42 day following treatment]

Secondary Outcome(s)

To determine the blood concentration of piperaquine to assess treatment adherence and the relationships of drug level at these times and treatment failure[On day 7 and day of recurrence]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Ministry of Health

Ethics review

Status: Approved
Approval date:
Contact:

Ethical Review Committee , World Health Organization (ERC, WHO)