An observational study in Plasmodium Falciparum Infection and Plasmodium Vivax Infection, sponsored by Menzies School of Health Research. Completed at 1 site in Indonesia. Open to participants aged 12 Months to 65 Years. Per ClinicalTrials.gov, last updated 2017-02-01.
Sponsored by Menzies School of Health Research · Observational
This is an observational safety and efficacy study on dihydroartemisinin-piperaquine in Timika, Indonesia with a 42 day follow up period.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 130 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Menzies School of Health Research is the lead sponsor of 45 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients suffering from uncomplicated Plasmodium falciparum / Plasmodium vivax infections attending the study hospital during the study period.
Exclusion criteria:
Treatment according to national guidelines with follow up.
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
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
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Menzies School of Health Research