Clinical trial NCT02353494: Efficacy and Safety of Dihydroartemisinin-piperaquine (DHP) for the Treatment of Uncomplicated Malaria
Official title: Efficacy and Safety of Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Plasmodium Falciparum and Plasmodium Vivax Malaria in Timika, Indonesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plasmodium Falciparum Infection
Plasmodium Vivax Infection
Lead sponsor: Menzies School of Health Research
Sponsor class: OTHER
Collaborators: name: Eijkman Institute for Molecular Biology
name: World Health Organization
First posted: 2015-02-02
Enrollment: 130
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from uncomplicated Plasmodium falciparum / Plasmodium vivax infections attending the study hospital during the study period.

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

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.

Eligibility 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

Primary outcomes:
measure: The proportion of adverse and serious adverse observed during the follow up period
timeFrame: 6 months
measure: The cumulative incidence of success and failure rates at day 42, PCR-uncorrected and PCR-corrected
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of patients aparasitaemic on days 1 and 2
timeFrame: 6 months
measure: Haematological recovery
timeFrame: 6 months
measure: Gametocyte carriage during follow up
timeFrame: 6 months
Other outcomes:
Locations:
city: Timika
country: Indonesia
facility: Timika District Hospital
Study officials:
affiliation: Timika Research Facility Kompleks RSMM, Timika-Papua, Indonesia
name: Jeanne R Poespoprodjo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: