Investigator(s)
| WHO Technical Officer |
Herdiana Hasan Basri WHO Indonesia Herdiana Hasan Basri 
|
| Principal Investigator |
Din Syafruddin Department Parasitology, Faculty of Medicine, Hasanuddin University Din Syafruddin
|
| Co-Investigator(s) |
Puji Budi Setia Asih Eijkman Research Centre for Molecular Biology, National Research and Innovation Agency Puji Budi Setia Asih
|
Title(s) and abstract
| Scientific title | Therapeutic Efficacy Study (TES) for first line of anti-malaria drug (Dihydroartemisinin Piperaquine/DHA-PPQ) at Kupang and West Sumba districts of NTT province, Indonesia |
| Public title | Study anti-malaria drug efficacy in NTT province, Indonesia |
| Background | Artemisinin-based combination therapy (ACT) has been adopted as first line therapy for uncomplicated falciparum malaria in Indonesia since 2004. Dihydroartemisinin–piperaquine (DHA–PPQ) has been used as first-line therapy for uncomplicated falciparum malaria in Indonesia since 2010. Reports to date revealed that DHA–PPQ is highly effective to treat any human malaria cases. Although certain studies reported few cases of delayed parasite clearance, this evidence was not linked to the artemisinin resistance. Routine monitoring of the therapeutic efficacy of ACT is essential for making timely changes of treatment policy. It can also help to detect early changes in the parasite susceptibility to anti-malarial drugs. The efficacy of DHA–PPQ will be evaluated in 2 sentinel sites in Kupang and South West Districts, East Nusa Tenggara. Currently, DHA-PPQ combination is the only available ACT in Indonesia and initial therapeutic efficacy studies conducted in several sentinel sites documented various efficacy and side effects. |
| Objectives | The present study aims is to evaluate the parasite clearance day and assess the efficacy and safety of DHA-PPQ for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax infections in Kupang and West Sumba Districts, East Nusa Tenggara Province, Indonesia. |
| Study Methods | The study will be designed as one arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria. Clinical and parasitological parameters will be monitored over 42 day by making blood films and blood blots on filter papers to evaluate drug efficacy following the guideline recommended by WHO. The participant’s enrolment will be conducted from November 2022 to July 2023. Two hundred and forty uncomplicated falciparum and vivax malaria cases will be enrolled through active and passive case detections upon informed consent and treated with DHA-PPQ from primary health centre containing 40 mg DHA and 320 mg PPQ per tablet and will be administered once a day for 3 days in front of study team and followed-up weekly for 42 days. Persons are aged between 1 and 65 years, weighed more than 5 kg, with fever or history of fever in the preceding 24 h, with slide-confirmed malaria with parasitaemia of ≥ 500/ul asexual parasites for P. falciparum and ≥ 250/ul asexual parasites for P. vivax. Persons will be excluded with the following exclusion criteria: pregnant, have a history of allergy to the study drugs or study drug’s derivative, have previously completed treatment with an anti-malarial drug in the preceding 2 weeks, or have a medical history of untreated hypertension or chronic heart, kidney, or liver disease. |
| Expected outcomes and use of results | Parasitological responses and classification of new infection, including lost to follow up and protocol violation will be classified according to criteria of the WHO. With this tight regulation it is hope that the expected outcomes from this study, DHA–PPQ is still highly effective in both sites and will continue to play a role in the treatment of uncomplicated malaria in Indonesia until malaria is successfully eliminated in the country. |
| Keywords | Therapeutic efficacy; P. falsiparum; P. vivax: Indonesia; Dihydroartemisinin Piperaquine |
Research Details
| Student research | No |
| Start Date | 21-Nov-2022 |
| End Date | 20-Jul-2023 |
| Key Implementing Institution | Department Parasitology, Faculty of Medicine, Hasanuddin University |
| Multi-country research | No |
| Nationwide research | No |
| Indonesia | |
| Research Domain(s) | Communicable Disease Research |
| Research field(s) | Malaria |
| Involves human subjects | Yes |
| Intervention Evaluation Research | |
| Data Collection | Primary data |
| Proposal reviewed by other Committee | Final decision available |