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).

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000214639
• Date of registration: 28/02/2014
• Prospective Registration: No
• Primary sponsor: Clinical Research Unit (malaria), Defense Services General Hospital
• 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)
• Date of first enrolment: 01/01/2014
• Target sample size: 200
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12614000214639.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 3 / Phase 4

Countries of recruitment

Myanmar

Contacts

• Name: Dr Khin Phyu Pyar

• Name: Dr Sai Aik Hla

Key inclusion & exclusion criteria

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

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.


Age minimum: 13 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Malaria;
Malaria

Infection - Other infectious diseases

Intervention(s)

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.

Primary Outcome(s)

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. [28 days after chloroquine and 42 days for dihydroartemisinine-piperaquine]

Secondary Outcome(s)

nil[nil]

Secondary ID(s)

Nil

Source(s) of Monetary Support

World Health Organization

Ethics review

Status: Approved
Approval date:
Contact:

Medical Ethics Committee

Status: Approved
Approval date:
Contact:

World Health Organization Research Ethics Review Committee