Efficacy and Safety of Dihydroartemisinin-piperaquine (DHP) for the Treatment of Uncomplicated Malaria
- Conditions
- Plasmodium Vivax InfectionPlasmodium Falciparum Infection
- Registration Number
- NCT02353494
- Lead Sponsor
- Menzies School of Health Research
- Brief Summary
This is an observational safety and efficacy study on dihydroartemisinin-piperaquine in Timika, Indonesia with a 42 day follow up period.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of adverse and serious adverse observed during the follow up period 6 months The cumulative incidence of success and failure rates at day 42, PCR-uncorrected and PCR-corrected 6 months
- Secondary Outcome Measures
Name Time Method Haematological recovery 6 months Proportion of patients aparasitaemic on days 1 and 2 6 months Gametocyte carriage during follow up 6 months
Trial Locations
- Locations (1)
Timika District Hospital
🇮🇩Timika, Indonesia