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Efficacy and Safety of Dihydroartemisinin-piperaquine (DHP) for the Treatment of Uncomplicated Malaria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02353494
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : February 1, 2017
Sponsor:
Collaborators:
Eijkman Institute for Molecular Biology
World Health Organization
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Plasmodium Falciparum Infection Plasmodium Vivax Infection Drug: Dihydroartemisinin-Piperaquine

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.

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Study Type : Observational
Actual Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria


Intervention Details:
  • Drug: Dihydroartemisinin-Piperaquine
    Treatment according to national guidelines with follow up.


Primary Outcome Measures :
  1. The proportion of adverse and serious adverse observed during the follow up period [ Time Frame: 6 months ]
  2. The cumulative incidence of success and failure rates at day 42, PCR-uncorrected and PCR-corrected [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Proportion of patients aparasitaemic on days 1 and 2 [ Time Frame: 6 months ]
  2. Haematological recovery [ Time Frame: 6 months ]
  3. Gametocyte carriage during follow up [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
Samples for genotyping of Plasmodium vivax and Plasmodium falciparum.


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering from uncomplicated Plasmodium falciparum / Plasmodium vivax infections attending the study hospital during the study period.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353494


Locations
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Indonesia
Timika District Hospital
Timika, Indonesia
Sponsors and Collaborators
Menzies School of Health Research
Eijkman Institute for Molecular Biology
World Health Organization
Investigators
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Principal Investigator: Jeanne R Poespoprodjo, MD, PhD Timika Research Facility Kompleks RSMM, Timika-Papua, Indonesia
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Responsible Party: Menzies School of Health Research
ClinicalTrials.gov Identifier: NCT02353494    
Other Study ID Numbers: Indonesia DHP 2013
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Malaria
Protozoan Infections
Parasitic Diseases
Piperaquine
Dihydroartemisinin
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents