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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000344695

Enrollment

240

Registered

2014-03-31

Start date

2013-11-09

Completion date

2013-11-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study is to evaluate the efficacy and safety of dihydroartemisinin-piperaquine for the treatment of uncomplicated P. falciparum and P. vivax malaria in Cambodia

Interventions

-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-administe

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

2 Years to 60 Years

Healthy volunteers

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

Outcome results