- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02353494
Efficacy and Safety of Dihydroartemisinin-piperaquine (DHP) for the Treatment of Uncomplicated Malaria
Efficacy and Safety of Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Plasmodium Falciparum and Plasmodium Vivax Malaria in Timika, Indonesia
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Timika, Indonesia
- Timika District Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The proportion of adverse and serious adverse observed during the follow up period
Time Frame: 6 months
|
6 months
|
The cumulative incidence of success and failure rates at day 42, PCR-uncorrected and PCR-corrected
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients aparasitaemic on days 1 and 2
Time Frame: 6 months
|
6 months
|
Haematological recovery
Time Frame: 6 months
|
6 months
|
Gametocyte carriage during follow up
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jeanne R Poespoprodjo, MD, PhD, Timika Research Facility Kompleks RSMM, Timika-Papua, Indonesia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Indonesia DHP 2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Plasmodium Falciparum Infection
-
SanofiMedicines for Malaria VentureCompletedPlasmodium Falciparum InfectionBenin, Burkina Faso, Gabon, Kenya, Uganda
-
SanofiMedicines for Malaria VentureTerminatedPlasmodium Falciparum InfectionBenin, Burkina Faso, Gabon, Kenya, Mozambique, Uganda, Vietnam
-
Papua New Guinea Institute of Medical ResearchSwiss Tropical & Public Health Institute; Walter and Eliza Hall Institute of... and other collaboratorsCompletedPlasmodium Falciparum Infection | Plasmodium Vivax Infection | Plasmodium Vivax Clinical Episode | Plasmodium Falciparum Clinical EpisodePapua New Guinea
-
Radboud University Medical CenterErasmus Medical Center; The PATH Malaria Vaccine Initiative (MVI); Havenzieke...CompletedPlasmodium Falciparum | Malaria,Falciparum | Plasmodium Berghei | Controlled Human Malaria Infection (CHMI)Netherlands
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...CompletedPlasmodium Falciparum InfectionUnited States
-
University of OxfordCompletedPlasmodium Falciparum InfectionMyanmar
-
SanofiTerminatedPlasmodium Falciparum InfectionBenin, Burkina Faso, Cameroon, Gabon, Kenya, Tanzania
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...CompletedPlasmodium Falciparum InfectionUnited States
Clinical Trials on Dihydroartemisinin-Piperaquine
-
London School of Hygiene and Tropical MedicineMedical Research Council Unit, The GambiaTerminated
-
University of OxfordMahidol Oxford Tropical Medicine Research UnitCompleted
-
Indonesia UniversityCompleted
-
Liverpool School of Tropical MedicineThe Research Council of Norway; Makerere University; Kenya Medical Research InstituteCompleted
-
Richard MwaisweloNational Institute for Medical Research, Tanzania; Muhimbili University of... and other collaboratorsCompletedMalaria | Chemoprophylaxis | Underfive ChildrenTanzania
-
National Institute for Medical Research, TanzaniaNational Malaria Control Program, TanzaniaActive, not recruiting
-
University of California, San FranciscoMahidol University; Holley-Cotec Pharmaceuticals Co., LTD.Completed
-
Centro de Investigação em Saúde de ManhiçaBarcelona Institute for Global HealthCompleted
-
London School of Hygiene and Tropical MedicineUniversity of Sheffield; Institute of Tropical Medicine, BelgiumCompleted
-
Simon KariukiCenters for Disease Control and PreventionCompleted