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

NCT02353494 | Completed

• 1 other identifier: Indonesia DHP 2013
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational safety and efficacy study on dihydroartemisinin-piperaquine in Timika, Indonesia with a 42 day follow up period.

Conditions

Plasmodium Falciparum Infection; Plasmodium Vivax Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Proportion of patients aparasitaemic on days 1 and 2

  6 months

• Haematological recovery

  6 months

• Gametocyte carriage during follow up

  6 months

Interventions

Dihydroartemisinin-Piperaquine DRUG

Treatment according to national guidelines with follow up.

Eligibility Criteria

• Age: 12 Months - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from uncomplicated Plasmodium falciparum / Plasmodium vivax infections attending the study hospital during the study period.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Menzies School of Health Research: lead
• Eijkman Institute for Molecular Biology: collaborator
• World Health Organization: collaborator

Study Sites (1)

Timika District Hospital

Timika, Indonesia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples for genotyping of Plasmodium vivax and Plasmodium falciparum.

Study Officials

• Jeanne R Poespoprodjo, MD, PhD

  Timika Research Facility Kompleks RSMM, Timika-Papua, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 2, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

ID (1)