Radical cure for vivax malaria in Indonesia

Recruitment & Eligibility

Status: Completed

Sex: Male

Target Recruitment: 240

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

1. Presence of clinical condition requiring hospitalization
2. Presence of significant anaemia, as defined by Hb < 8 g/dL
3. G6PD deficient determined by a standard qualitative test
4. Definite plans for an absence of 3 days or more from the base within 28 days of being enrolled
5. Known history or evidence of clinically significant disorders:
5.1. Cardiovascular
5.2. A corrected QT interval (QTc) >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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Measure the efficacy of the two primaquine combination regimens against relapse, relative to the relapse rate of the artesunate alone regimen.<br><br>Relapse efficacy is defined as:<br>100% x natural relapse rate - relapse rate post-PQ/natural relapse rate