Efficacy and Safety of Dihydroartemisinin-piperaquine (DHP) for the Treatment of Uncomplicated Malaria
|ClinicalTrials.gov Identifier: NCT02353494|
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : February 1, 2017
|Condition or disease||Intervention/treatment|
|Plasmodium Falciparum Infection Plasmodium Vivax Infection||Drug: Dihydroartemisinin-Piperaquine|
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.
|Study Type :||Observational|
|Actual Enrollment :||130 participants|
|Official Title:||Efficacy and Safety of Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Plasmodium Falciparum and Plasmodium Vivax Malaria in Timika, Indonesia|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
- Drug: Dihydroartemisinin-Piperaquine
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 ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353494
|Timika District Hospital|
|Principal Investigator:||Jeanne R Poespoprodjo, MD, PhD||Timika Research Facility Kompleks RSMM, Timika-Papua, Indonesia|