Malaria Infections and Infestations Plasmodium vivax malaria
Conditions
Interventions
A single center randomized open label non-inferiority study of PQ treatment against the cumulative relapse rate over 1 year when administered with two different companion blood schizontocides as radic
Kimia Pharma, Bandung, Indonesia) of 200mg base three times daily for 7 days plus concurrent dosing with 0.5mg/kg primaquine base once daily for 14 days (Malafree™
15mg primaquine base/tablet
Shin Poon Pharmaceuticals, Seoul, South Korea)
2. DHA-PP+PQ = combined dihydroartemsinin plus piperaquine (Euartesim™, Sigma Tau, Italy
40mg dihydroartemisinin base and 320mg of piperaquine base per tablet) of three tablets for participants 75kg for three days, followed by 0.5mg/kg primaquine daily for 14 days commencing on day 28 af
Guilin Pharmaceuticals Co. Ltd, Shanghai, China) was administered in a total dose of 200mg on day of enrollment, followed by a single daily dose for 6 more days
Follow up was for 365 days, counting
Sponsors
Eijkman-Oxford Clinical Research Unit (Indonesia)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male patients between the age of 18 and 60 years 2. Traveled for >1 month to north eastern Papua within the past 12 months 3. Body weight > 40 kg and = 90 kg 4. Presence of P. vivax parasitemia mono- or mixed infection with another plasmodial species confirmed by positive microscopy of P. vivax with parasite density =20/ µL of blood 5. Written informed consent provided by patient. If the patient was unable to write, witnessed consent was permitted 6. Glucose-6-phosphate dehydrogenase (G6PD) normal using the nicotinamide adenine dinucleotide phosphate-oxidase (NADPH) qualitative fluorescent spot test (Trinity Biologicals, USA) 7. Able to swallow oral medication 8. Able and willing to participate based on information given to patient
Exclusion criteria
Exclusion criteria: 1. Presence of clinical condition requiring hospitalization 2. Presence of significant anaemia, as defined by Hb 450 ms* 5.3. Respiratory, including active tuberculosis 5.4. Hepatic 5.5. Renal 5.6. Gastrointestinal 5.7. Immunological 5.8. Neurological, including hearing impairment 5.9. Endocrine 5.10. Infectious 5.11. Malignancy 5.12. Psychiatric 6. Recent head trauma 7. Any other clinically significant finding that the investigator judges will place the patient at risk or interfere with the study results 8. Known to have or be confirmed: 8.1. Active Hepatitis A (e.g. by detection of anti HAV-IgM) 8.2. Hepatitis B surface antigen (HBsAg) carrier 8.3. Hepatitis C antibody (HCV Ab). 9. Liver function tests (AST/ALT levels) more than 2.5 times the upper limit of normal range 10. Renal impairment as indicated by abnormal creatinine clearance of < 60 ml/min, measured using Cockcroft-Gault formula 11. Known history of hypersensitivity, allergy or adverse reactions to piperaquine, quinine or primaquine, artesunate, dihydroartemisinin (DHA) or other artemisinins 12. Previous participation in the present clinical trial with DHA/PQP 13. Had received any investigational drug within the past 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure and compare, using a non-inferior design, the cumulative relapse rate over one year of the two arms relative to the natural relapse rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Measure the efficacy of the two primaquine combination regimens against relapse, relative to the relapse rate of the artesunate alone regimen. Relapse efficacy is defined as: 100% x natural relapse rate - relapse rate post-PQ/natural relapse rate | — |
Countries
Indonesia
Outcome results
None listed