This trial is active, not recruiting.

Conditions plasmodium falciparum infection, plasmodium vivax infection
Treatment dihydroartemisinin-piperaquine
Sponsor Menzies School of Health Research
Collaborator Eijkman Institute for Molecular Biology, Jakarta, Indonesia
Start date March 2015
End date August 2016
Trial size 200 participants
Trial identifier NCT02353494, Indonesia DHP 2013


This is an observational safety and efficacy study on dihydroartemisinin-piperaquine in Timika, Indonesia with a 42 day follow up period.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

The proportion of adverse and serious adverse observed during the follow up period
time frame: 6 months
The cumulative incidence of success and failure rates at day 42, PCR-uncorrected and PCR-corrected
time frame: 6 months

Secondary Outcomes

Proportion of patients aparasitaemic on days 1 and 2
time frame: 6 months
Haematological recovery
time frame: 6 months
Gametocyte carriage during follow up
time frame: 6 months

Eligibility Criteria

Male or female participants from 12 months up to 65 years old.

Inclusion criteria: - age between one year (weight more than 5 kgs) to 65 years old; - mono-infection with Plasmodium falciparum or Plasmodium vivax detected by microscopy; - parasitaemia of more than 1000/μl asexual parasites for P. falciparum and more than 250/μl asexual parasites for P. vivax - presence of axillary temperature ≥ 37.5 °C 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 - 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 dihydroartemisinin-piperaquine - a positive pregnancy test or breastfeeding

Additional Information

Official title Efficacy and Safety of Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Plasmodium Falciparum and Plasmodium Vivax Malaria in Timika, Indonesia
Principal investigator Jeanne R Poespoprodjo, MD, PhD
Description Dihydroartemisinin-piperaquine (DHA-Pip) is part of the current national guidelines for the treatment of uncomplicated malaria in Indonesia. In order to guarantee safe and efficacious treatment for all patients diagnosed with uncomplicated malaria in the area, it is essential to monitor the effectiveness of the recommended treatment from a clinical perspective and assess whether the provided treatment is safe for recipients. This trial re-evaluates the local efficacy and safety of DHA-Pip for P. falciparum and P. vivax infections. Patients with uncomplicated malaria attending a public health care facility in Timika, Papua, Indonesia, who meet the study inclusion criteria will be enrolled, treated on site with DHA-Pip and followed up for 42 days. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. On the basis of the results of these assessments, the patients will be classified as having therapeutic failure (early or late) or an adequate response. The proportion of patients experiencing therapeutic failure and drug related adverse events during the follow-up period will be used to estimate the efficacy and safety of the study drug. PCR analysis will be used to distinguish between a true recrudescence due to treatment failure and episodes of reinfection. The outcome of the proposed project will have a direct impact on the decision making process of the Indonesian Ministry of Health on whether there is a need to alter the existing antimalarial treatment guidelines.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Menzies School of Health Research.