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

Plasmodium Falciparum Infection Clinical Trial

Official title:

Efficacy and Safety of Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Plasmodium Falciparum and Plasmodium Vivax Malaria in Timika, Indonesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02353494
• Other study ID #: Indonesia DHP 2013
• Status: Completed
• Phase: N/A
• First received: January 28, 2015
• Last updated: January 31, 2017
• Start date: March 2015
• Est. completion date: May 2016

Study information

• Verified date: January 2017
• Source: Menzies School of Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Malaria
• Plasmodium Falciparum Infection
• Plasmodium Vivax Infection

Intervention

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

Locations

Country	Name	City	State
Indonesia	Timika District Hospital	Timika

Sponsors (3)

Lead Sponsor	Collaborator
Menzies School of Health Research	Eijkman Institute for Molecular Biology, Jakarta, Indonesia, World Health Organization

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of adverse and serious adverse observed during the follow up period		6 months
Primary	The cumulative incidence of success and failure rates at day 42, PCR-uncorrected and PCR-corrected		6 months
Secondary	Proportion of patients aparasitaemic on days 1 and 2		6 months
Secondary	Haematological recovery		6 months
Secondary	Gametocyte carriage during follow up		6 months