Therapeutic Efficacy Study (TES) For First Line of Antimalaria Drug (Dihydroartemisinin Piperaquine/DHP) in Two Sentinel Sites in Indonesia
Therapeutic Efficacy Study (TES) For First Line of Antimalaria Drug (Dihydroartemisinin Piperaquine/DHP) in Individuals Infected with Plasmodium falciparum or Plasmodium vivax at Two Sentinel Sites in Indonesia
World Health Organization, Country Office Indonesia
142 participants
Nov 23, 2020
Interventional
Conditions
Summary
Title: Therapeutic Efficacy Study (TES) for First Line Anti-Malarial Drug (Dihydroartemisinin Piperaquine/DHP) in two sentinel sites in Indonesia. Purpose: To assess the efficacy of the current first treatment policy Objective: To assess the efficacy and safety of dihydroartemisinin-piperaquine for the treatment of uncomplicated P. falciparum and P. vivax malaria infections. Study Sites: Papua Province (2 Districts at the Border area with Papua New Guinea) Study Period: November 2020 to September 2021 . Study Design: One arm prospective study. Patient population: Febrile patients aged between one year to 65 years old, with confirmed uncomplicated P. falciparum or P. vivax infection. Young female of child bearing age (between 12-17 years) will be excluded due to culturally sensitive reasons. Sample Size: A total of 240 patients (60 with P. falciparum and 60 with P. vivax malaria) will be enrolled in each site per each antimalarial drug. Treatment(s) and follow-up: DHA-PPQ (containing 40 mg dihydroartemisinin and 320 mg piperaquine) tablets will be administered once a day for 3 days, administered as a weight per dose regimen of 2.25 and 18 mg/kg of dihydroartemisinin and piperaquine. Clinical and parasitological parameters will be monitored over a 42-day follow-up period to evaluate drug efficacy. Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis. Secondary endpoints: The frequency and nature of adverse events. Optional exploratory endpoints: To determine the polymorphism of molecular markers for artemisinin resistance (K13).
Eligibility
Inclusion Criteria8
- age between one year (weight more than 5 kgs) to 65 years old;
- mono-infection with P. falciparum or P. vivax detected by microscopy;
- parasitaemia of more than 500 asexual parasites/µl for P. falciparum and 250 asexual parasites/µl P. vivax
- presence of axillary temperature 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 aged less than 17 years (age of majority in this country)
- informed assent from any minor participant aged from 12 to age of majority years; and
Exclusion Criteria8
- presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO; presence of danger signs in patients with P. vivax infections
- 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), included COVID-19;
- regular medication, which may interfere with antimalarial pharmacokinetics;
- history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); and
- a positive pregnancy test or breastfeeding (include this criterion only if adults are included)
- unable to or unwilling to take pregnancy test or to use contraception for married women; or young females of child bearing age (12 years and above or those who had their menarche) will be excluded due to culturally sensitive reasons in Indonesia.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DHA-PPQ (containing 40 mg dihydroartemisinin and 320 mg piperaquine) tablets will be administered once a day for 3 days, administered as a weight per dose regimen of 2.25 and 18 mg/kg of dihydroartemisinin and piperaquine.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12622000248763